Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT04770220
Status:
COMPLETED
Last Update Posted:
2025-11-07
First Post:
2021-02-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'aidan.power@alzheon.com', 'phone': '(508) 861-7709', 'title': 'Aidan Power', 'organization': 'Alzheon'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'All AEs (deaths, Serious Adverse Events, Other Adverse Events) were recorded for up to 95 weeks (13 weeks screening + 78-week treatment + 4 weeks follow-up). All AEs were collected from ICF signing at screening through Safety Follow-up Visit 4 weeks after last efficacy visit at week 78. Medical conditions present at screening were captured as medical history. However, if a condition deteriorated, it was recorded as an AE.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID', 'otherNumAtRisk': 162, 'deathsNumAtRisk': 162, 'otherNumAffected': 94, 'seriousNumAtRisk': 162, 'deathsNumAffected': 0, 'seriousNumAffected': 13}, {'id': 'EG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID', 'otherNumAtRisk': 163, 'deathsNumAtRisk': 163, 'otherNumAffected': 104, 'seriousNumAtRisk': 163, 'deathsNumAffected': 0, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 35}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 42}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Weight Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 23}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 10}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 10}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Cerebral Microhaemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 8}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Decreased Appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 16}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 9}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 16}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Amyloid related imaging abnormality - microhaemorrhages and heamosiderin deposits', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 6}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Anxiety', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 6}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 7}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}], 'seriousEvents': [{'term': 'Angina Pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Cardiac Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Coronary Artery Stenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Myocardial Infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Myocardial Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Hyperthyroidism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Endocrine disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Intestinal Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Chest Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Cholecystitis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Gallbladder necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Cholecystitis Infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Pneumonia Aspiration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Pyelonephritis Acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Ankle Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Bladder Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Femur Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Incarcerated Incisional Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Pelvic Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Blood Calcium Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Blood Potassium Decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Hyponatraemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Glioblastoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Malignant Melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Thyroid Cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Transient Ischaemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Paranoia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Atelectasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 163, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 162, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 163, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 26.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Cognitive Efficacy Endpoint (ADAS-Cog13)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '4.40', 'spread': '0.69', 'groupId': 'OG000'}, {'value': '3.89', 'spread': '0.69', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6058', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.51', 'pValueComment': 'Statistical testing was two-sided at the α=0.05 significance level. Between-treatment group comparison (effect in ALZ-801 minus effect in placebo): LSM difference and p-value.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.98', 'estimateComment': 'ALZ-801 minus placebo', 'groupDescription': 'The null hypothesis was change from baseline (CBL) of ADAS-Cog13 in the ALZ-801 arm was not different from the placebo arm. The alternative hypothesis was that the CBL of ADAS-Cog13 in ALZ-801 arm was different.\n\nA Mixed-Effect Model Repeated Measure (MMRM) model was used with fixed terms for treatment, gender, age group, disease severity based on baseline MMSE (≤ 26 vs. \\> 26), concomitant AD medications, visit, and treatment by visit interaction and baseline ADAS-Cog 13 values as covariates.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER', 'nonInferiorityComment': 'For the primary efficacy outcome of ADAS-Cog 13, this study has \\>90% power to detect a 3.0-point difference between the active ALZ-801 treatment and the placebo in the CBL to Week 78. An increase in ADAS-Cog scores denotes cognitive worsening.\n\nThe primary analysis population was the full analysis set (FAS). The FAS included all study subjects who received at least one dose of the study drug and had at least one baseline assessment and any post baseline efficacy assessment.'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13) scores.\n\nThe ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Full Analysis Set (FAS): The FAS includes all study subjects who received at least one dose of the study drug, had at least one baseline assessment and any post baseline efficacy assessment. All primary and secondary clinical efficacy analyses are conducted on this population.'}, {'type': 'PRIMARY', 'title': 'Incidence, Nature, and Severity of Treatment Emergent Adverse Events (TEAE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'OG000'}, {'value': '163', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'title': 'TEAE', 'categories': [{'measurements': [{'value': '137', 'groupId': 'OG000'}, {'value': '140', 'groupId': 'OG001'}]}]}, {'title': 'Study drug related TEAE', 'categories': [{'measurements': [{'value': '44', 'groupId': 'OG000'}, {'value': '75', 'groupId': 'OG001'}]}]}, {'title': 'Serious TEAE', 'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}, {'title': 'Serious study drug related TEAE', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'TEAE leading to discontinuation of study drug', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}]}, {'title': 'Study drug related TEAE leading to study drug discontinuation', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks)', 'description': 'Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAEs, and TEAEs leading to withdrawal.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety Population: subjects who took at least 1 dose of any study drug are included.'}, {'type': 'SECONDARY', 'title': 'Key Secondary Endpoint (A-IADL-W)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '13.59', 'spread': '2.02', 'groupId': 'OG000'}, {'value': '13.60', 'spread': '2.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.9966', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.01', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.84', 'estimateComment': 'ALZ-801 minus placebo', 'groupDescription': 'The A-IADL-W is one of 2 key secondary endpoints. The key secondary efficacy endpoints were to be compared only after the comparison of the primary endpoint has reached statistical significance. Because the primary endpoint did not reach statistical significance, the comparisons for the key secondary endpoints are descriptive only.\n\nThe same MMRM method applied to the primary efficacy endpoint was used to evaluate the between-treatment difference for the key secondary endpoints.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Nominal (descriptive only)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Key Secondary Endpoint (CDR-SB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1.36', 'spread': '0.21', 'groupId': 'OG000'}, {'value': '1.05', 'spread': '0.22', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3090', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.31', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.31', 'estimateComment': 'ALZ-801 minus placebo', 'groupDescription': 'The CDR-SB is one of 2 key secondary endpoints. The key secondary efficacy endpoints were to be compared only after the comparison of the primary endpoint has reached statistical significance. Because the primary endpoint did not reach statistical significance, the comparisons for the key secondary endpoints are descriptive only.\n\nThe same MMRM method applied to the primary efficacy endpoint was used to evaluate the between-treatment difference for the key secondary endpoints.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Functional Assessment (DAD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.2', 'spread': '1.7', 'groupId': 'OG000'}, {'value': '-6.5', 'spread': '1.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2763', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2.6', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.4', 'estimateComment': 'ALZ-801 minus placebo', 'groupDescription': 'The same MMRM method applied to the primary efficacy endpoint was used to evaluate the between-treatment difference for the additional secondary endpoints. The hypothesis testing was done without control for type I errors due to multiple comparisons, and the p-value was considered nominal.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Nominal (descriptive only)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'SECONDARY', 'title': 'Global Cognition Assessment (MMSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '158', 'groupId': 'OG000'}, {'value': '162', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.03', 'spread': '0.33', 'groupId': 'OG000'}, {'value': '-1.60', 'spread': '0.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.4484', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.35', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.47', 'estimateComment': 'ALZ-801 minus placebo', 'groupDescription': 'The same MMRM method applied to the primary efficacy endpoint was used to evaluate the between-treatment difference for the additional secondary endpoints. The hypothesis testing was done without control for type I errors due to multiple comparisons, and the p-value was considered nominal.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Nominal (descriptive only)'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE is a measure of global cognition that is widely used for clinical staging of Alzheimer's Disease. It consists of 11 domains items for a score range of 0-30 to assess general cognitive function. Higher score on MMSE means better cognitive skills.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Imaging Biomarker Endpoint (Hippocampal Volume)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-418.5', 'spread': '21.46', 'groupId': 'OG000'}, {'value': '-345.0', 'spread': '22.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0174', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '73.505', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '30.711', 'estimateComment': 'ALZ-801 minus placebo.', 'groupDescription': 'Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \\> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) hippocampal volume (HV) (uL) as measured by Magnetic Resonance Imaging (MRI). HV atrophy is an early event in AD patients, especially in APOE4/4 homozygotes who show accelerated atrophy compared to APOE3/3 patients with Early AD. HV may be a marker of synaptic loss and neurodegeneration.', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Imaging Biomarker population included all subjects with an evaluable baseline vMRI assessment who had received at least 1 dose of study drug and had at least 1 evaluable post-baseline imaging vMRI assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Imaging Biomarker Endpoint (Cortical Thickness [Whole Cortex])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.060', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '-0.048', 'spread': '0.003', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.012', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.004', 'estimateComment': 'ALZ-801 minus placebo', 'groupDescription': 'Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \\> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Imaging Biomarker Endpoint (Cortical Thickness [Mayo Index])', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.121', 'spread': '0.005', 'groupId': 'OG000'}, {'value': '-0.099', 'spread': '0.005', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0040', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.021', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.007', 'estimateComment': 'ALZ-801 minus placebo', 'groupDescription': 'Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \\> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration. The Mayo Index refers specifically to the measurement of cortical thickness in the medial temporal lobe.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Imaging Biomarker Endpoint (Whole Brain Volume)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-17877.0', 'spread': '955.98', 'groupId': 'OG000'}, {'value': '-15056.0', 'spread': '979.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0400', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2821.027', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1366.533', 'estimateComment': 'ALZ-801 minus placebo', 'groupDescription': 'Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \\> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in whole brain volume (uL) as measured by Magnetic Resonance Imaging (MRI).', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Imaging Biomarker Endpoint (Ventricular Volume)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '5186.3', 'spread': '256.19', 'groupId': 'OG000'}, {'value': '4028.9', 'spread': '262.86', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0018', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1157', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '367', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) ventricular volume (uL) as measured by Magnetic Resonance Imaging (MRI).', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Imaging Biomarker Endpoint - DTI in Grey Matter Mean Diffusivity - Bilateral Caudate', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.000028', 'spread': '0.00000775', 'groupId': 'OG000'}, {'value': '0.000007439', 'spread': '0.00000792', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0000214', 'ciLowerLimit': '-0.0000432', 'ciUpperLimit': '0.00000037', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.00000111', 'estimateComment': 'ALZ-801 minus placebo', 'groupDescription': 'Analysis of the DTI-MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \\> 65 years), gender, disease severity based on baseline MMSE, baseline DTI-MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Grey Matter Mean Diffusivity (Bilateral Caudate) as measured by Diffusion Tensor Imaging - Magnetic Resonance Imaging (DTI-MRI). The mean diffusivity (MD) is the average of the three main diffusion values (eigenvalues) obtained from the diffusion tensor imaging (DTI). It is expressed as mm2/s. This unit quantifies the average rate of water diffusion across all directions within a tissue, providing an overall measure of tissue microstructural properties. Lower MD value suggests better maintenance of microstructural integrity of a given brain tissue. Positive treatment effects of ALZ-801 on DTI would present as lower mean diffusivity compared with the placebo group.', 'unitOfMeasure': 'square millimeters per second (mm²/s)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'DTI-MRI Population defined as all participants who had an evaluable baseline DTI-MRI assessment, received at least one dose of study drug, and had at least one evaluable post-baseline DTI-MRI assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Imaging Biomarker Endpoint - DTI in White Matter Mean Diffusivity (Bilateral Fornix)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0000237', 'spread': '0.0000058', 'groupId': 'OG000'}, {'value': '0.000000843', 'spread': '0.00000593', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0064', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.0000228', 'ciLowerLimit': '-0.0000391', 'ciUpperLimit': '-0.0000065', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.00000829', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Bilateral Fornix White Matter Mean Diffusivity as measured by Diffusion Tensor Imaging - Magnetic Resonance Imaging (DTI-MRI). The mean diffusivity (MD) is the average of the three main diffusion values (eigenvalues) obtained from the diffusion tensor imaging (DTI). It is expressed as mm2/s. This unit quantifies the average rate of water diffusion across all directions within a tissue, providing an overall measure of tissue microstructural properties. Lower MD value suggests better maintenance of microstructural integrity of a given brain tissue. Positive treatment effects of ALZ-801 on DTI would present as lower mean diffusivity compared with the placebo group.', 'unitOfMeasure': 'square millimeters per second (mm²/s)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'DTI-MRI Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Imaging Biomarker Endpoint - White Matter Fractional Anisotropy (Bilateral Fornix)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '103', 'groupId': 'OG000'}, {'value': '105', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0154', 'spread': '0.00332', 'groupId': 'OG000'}, {'value': '-0.002089', 'spread': '0.00336', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0465', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.009455', 'ciLowerLimit': '0.0001469', 'ciUpperLimit': '0.01876', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.00472', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Bilateral Fornix White Matter Fractional Anisotropy as measured by Diffusion Tensor Imaging - Magnetic Resonance Imaging (DTI-MRI). Fractional anisotropy (FA) is a unitless, scalar value that measures the degree of anisotropic (directional) water diffusion within a voxel, ranging from 0 to 1. A value of 0 indicates perfectly isotropic (equal in all directions) diffusion, while a value of 1 indicates perfectly anisotropic (directional) diffusion. Higher FA value suggests better maintenance of microstructural integrity of a given brain tissue. Positive treatment effects of ALZ-801 on DTI would present as higher FA in the ALZ-801 group compared with the placebo group.', 'unitOfMeasure': 'Units on a scale (fractions 0-1)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'DTI-MRI Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cognitive Efficacy Endpoint (ADAS-Cog 13) - MCI Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '4.10', 'spread': '0.81', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.83', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0416', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-2.14', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.05', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks.\n\nThe ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS MCI subgroup: all study subjects in the MCI subgroup who received at least one dose of the study drug, had at least one baseline assessment and any post baseline efficacy assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': "Cognitive Efficacy Endpoint (ADAS-Cog 13) - Mild Alzheimer's Disease(Mild AD) Subgroup", 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '4.79', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '5.66', 'spread': '0.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3945', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.87', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1.02', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks.\n\nThe ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Mild AD subgroup: all study subjects in the Mild AD subgroup who received at least one dose of the study drug, had at least one baseline assessment and any post baseline efficacy assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'A-IADL-W - MCI Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '4.84', 'spread': '2.45', 'groupId': 'OG000'}, {'value': '1.43', 'spread': '2.50', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2682', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-3.41', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '3.07', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS MCI Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'A-IADL-W - Mild AD Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '18.55', 'spread': '2.21', 'groupId': 'OG000'}, {'value': '22.20', 'spread': '2.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2178', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3.66', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.96', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Mild AD Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CDR-SB - MCI Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '0.63', 'spread': '0.26', 'groupId': 'OG000'}, {'value': '-0.02', 'spread': '0.27', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0533', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.646', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.333', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS MCI Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'CDR-SB - Mild AD Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '1.84', 'spread': '0.23', 'groupId': 'OG000'}, {'value': '1.97', 'spread': '0.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.6854', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.127', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.314', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Mild AD Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Functional Assessment (DAD) - MCI Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.3', 'spread': '1.9', 'groupId': 'OG000'}, {'value': '-0.2', 'spread': '2.0', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0161', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '6.10', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.52', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS MCI Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Functional Assessment (DAD) - Mild AD Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-11.1', 'spread': '1.8', 'groupId': 'OG000'}, {'value': '-11.6', 'spread': '1.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8387', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.51', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.51', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Mild AD Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Global Cognition Assessment (MMSE) - MCI Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.4', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-0.5', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0795', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.9', 'ciLowerLimit': '-0.103', 'ciUpperLimit': '1.845', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE is a measure of global cognition that is widely used for clinical staging of Alzheimer's Disease. It consists of 11 domains items for a score range of 0-30 to assess general cognitive function. Higher score on MMSE means better cognitive skills.", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS MCI Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Global Cognition Assessment (MMSE) - Mild AD Subgroup', 'denoms': [{'units': 'Participants', 'counts': [{'value': '100', 'groupId': 'OG000'}, {'value': '95', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.6', 'spread': '0.4', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '0.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.8169', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.1', 'ciLowerLimit': '-1.070', 'ciUpperLimit': '0.845', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.5', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE is a measure of global cognition that is widely used for clinical staging of Alzheimer's Disease. It consists of 11 domains items for a score range of 0-30 to assess general cognitive function. Higher score on MMSE means better cognitive skills.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS Mild AD Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hippocampal Volume (MCI Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-411.2', 'spread': '29.60', 'groupId': 'OG000'}, {'value': '-303.1', 'spread': '30.16', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '108.1', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '37.46', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) hippocampal volume (HV) (uL) as measured by Magnetic Resonance Imaging (MRI). HV atrophy is an early event in AD patients, especially in APOE4/4 homozygotes who show accelerated atrophy compared to APOE3/3 patients with Early AD. HV may be a marker of synaptic loss and neurodegeneration.', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population MCI Subgroup: this population included all subjects in the MCI subgroup with an evaluable baseline vMRI assessment who had received at least 1 dose of study drug and had at least 1 evaluable post-baseline imaging vMRI assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Hippocampal Volume (Mild AD Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-423.2', 'spread': '23.27', 'groupId': 'OG000'}, {'value': '-371.8', 'spread': '24.75', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1145', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '51.3', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '32.42', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) hippocampal volume (HV) (uL) as measured by Magnetic Resonance Imaging (MRI). HV atrophy is an early event in AD patients, especially in APOE4/4 homozygotes who show accelerated atrophy compared to APOE3/3 patients with Early AD. HV may be a marker of synaptic loss and neurodegeneration.', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population Mild AD Subgroup: this population included all subjects with an evaluable baseline vMRI assessment who had received at least 1 dose of study drug and had at least 1 evaluable post-baseline imaging vMRI assessment.'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cortical Thickness (Whole Cortex) (MCI Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.059', 'spread': '0.004', 'groupId': 'OG000'}, {'value': '-0.038', 'spread': '0.004', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '< 0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.020', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.005', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population MCI Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cortical Thickness (Whole Cortex) (Mild AD Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.061', 'spread': '0.003', 'groupId': 'OG000'}, {'value': '-0.054', 'spread': '0.003', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0985', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.007', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.004', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population Mild AD Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cortical Thickness (Mayo Index) (MCI Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.117', 'spread': '0.007', 'groupId': 'OG000'}, {'value': '-0.084', 'spread': '0.007', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.033', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.009', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration. The Mayo Index refers specifically to the measurement of cortical thickness in the medial temporal lobe versus the whole cortex.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population MCI Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Cortical Thickness (Mayo Index) (Mild AD Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.123', 'spread': '0.006', 'groupId': 'OG000'}, {'value': '-0.109', 'spread': '0.006', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0699', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.014', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.008', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration. The Mayo Index refers specifically to the measurement of cortical thickness in the medial temporal lobe versus the whole cortex.", 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population Mild AD Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Whole Brain Volume (MCI Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-17559.5', 'spread': '1417.91', 'groupId': 'OG000'}, {'value': '-13715.7', 'spread': '1449.14', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0267', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '3843.824', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1726.729', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in whole brain volume (uL) as measured by Magnetic Resonance Imaging (MRI).', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population MCI Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Whole Brain Volume (Mild AD Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-18081.4', 'spread': '1056.74', 'groupId': 'OG000'}, {'value': '-15917.1', 'spread': '1143.24', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1386', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '2164.299', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '1457.282', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in whole brain volume (uL) as measured by Magnetic Resonance Imaging (MRI).', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population Mild AD Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ventricular Volume (MCI Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '4490.5', 'spread': '343.65', 'groupId': 'OG000'}, {'value': '3178.2', 'spread': '350.44', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1312', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '437', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) ventricular volume (uL) as measured by Magnetic Resonance Imaging (MRI).', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population MCI Subgroup'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Ventricular Volume (Mild AD Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '5630.4', 'spread': '274.91', 'groupId': 'OG000'}, {'value': '4573.4', 'spread': '294.71', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0065', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1057', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '386', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) ventricular volume (uL) as measured by Magnetic Resonance Imaging (MRI).', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population Mild AD Subgroup'}, {'type': 'POST_HOC', 'title': 'Cerebellar Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '144', 'groupId': 'OG000'}, {'value': '146', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-577.0', 'spread': '62.50', 'groupId': 'OG000'}, {'value': '-427.2', 'spread': '64.70', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0966', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '149.800', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '89.801', 'groupDescription': 'Analysis of the volumetric MRI outcomes were performed using the same MMRM approach described for analysis of the primary clinical endpoint. The MMRM model included treatment, the use of concomitant AD medications (AChEI or none), age group (50 through 65 years or \\> 65 years), gender, disease severity based on baseline MMSE, baseline volumetric MRI value, visit, and treatment by visit interaction. The MRI magnet strength (1.5 or 3 Tesla) was also included as a covariate in the model.', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) cerebellar volume (uL) as measured by Magnetic Resonance Imaging (MRI).', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population'}, {'type': 'POST_HOC', 'title': 'Cerebellar Volume (MCI Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-566.8', 'spread': '91.78', 'groupId': 'OG000'}, {'value': '-428.8', 'spread': '94.09', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2200', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '137.943', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '112.257', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) cerebellar volume (uL) as measured by Magnetic Resonance Imaging (MRI).', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population MCI Subgroup'}, {'type': 'POST_HOC', 'title': 'Cerebellar Volume (Mild AD Subgroup)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '92', 'groupId': 'OG000'}, {'value': '85', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'OG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'classes': [{'categories': [{'measurements': [{'value': '-583.6', 'spread': '68.62', 'groupId': 'OG000'}, {'value': '-426.2', 'spread': '75.18', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.1005', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Least Squares Mean Difference', 'ciNumSides': 'TWO_SIDED', 'paramValue': '157.414', 'pValueComment': 'Nominal p-value', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '95.523', 'statisticalMethod': 'MMRM', 'nonInferiorityType': 'OTHER'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) cerebellar volume (uL) as measured by Magnetic Resonance Imaging (MRI).', 'unitOfMeasure': 'microliters', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Imaging Biomarker Population Mild AD Subgroup'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'FG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '162'}, {'groupId': 'FG001', 'numSubjects': '163'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '148'}, {'groupId': 'FG001', 'numSubjects': '132'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '31'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'not otherwise specified', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study\n\nPlacebo Comparator: Placebo: Placebo tablet BID'}, {'id': 'BG001', 'title': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one table of ALZ-801 265mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265mg tablet BID.\n\nExperimental: ALZ-801: ALZ-801 tablet 265 mg BID'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '68.5', 'spread': '5.93', 'groupId': 'BG000'}, {'value': '68.4', 'spread': '6.36', 'groupId': 'BG001'}, {'value': '68.5', 'spread': '6.14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Age, Customized', 'classes': [{'title': '50 to <=65', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}]}, {'title': '>65 to 80', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '114', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '82', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '167', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '78', 'groupId': 'BG001'}, {'value': '158', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '145', 'groupId': 'BG000'}, {'value': '144', 'groupId': 'BG001'}, {'value': '289', 'groupId': 'BG002'}]}]}, {'title': 'Multiple Races', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Race Not Reported/Missing', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '18', 'groupId': 'BG002'}]}]}, {'title': 'Hispanic/Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}, {'title': 'Not Hispanic/Latino', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '141', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '288', 'groupId': 'BG002'}]}]}, {'title': 'Ethnicity Not Reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': "Alzheimer's Diagnosis based on MMSE", 'classes': [{'title': 'Mild cognitive impairment (MCI) MMSE 27-30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}]}, {'title': "Mild Alzheimer's Disease (Mild AD) MMSE 22-26", 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '102', 'groupId': 'BG000'}, {'value': '96', 'groupId': 'BG001'}, {'value': '198', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Concomitant AChEI', 'classes': [{'title': 'Yes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '116', 'groupId': 'BG002'}]}]}, {'title': 'No', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '109', 'groupId': 'BG001'}, {'value': '209', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Baseline Clinical Outcomes Assessments (Safety Population)', 'classes': [{'title': 'ADAS-Cog13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24.31', 'spread': '8.86', 'groupId': 'BG000'}, {'value': '23.554', 'spread': '8.26', 'groupId': 'BG001'}, {'value': '23.93', 'spread': '8.56', 'groupId': 'BG002'}]}]}, {'title': 'A-IADL-W', 'denoms': [{'units': 'Participants', 'counts': [{'value': '161', 'groupId': 'BG000'}, {'value': '160', 'groupId': 'BG001'}, {'value': '321', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17.46', 'spread': '20.65', 'groupId': 'BG000'}, {'value': '16.00', 'spread': '18.42', 'groupId': 'BG001'}, {'value': '16.73', 'spread': '19.55', 'groupId': 'BG002'}]}]}, {'title': 'CDR-SB', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2.97', 'spread': '1.45', 'groupId': 'BG000'}, {'value': '3.04', 'spread': '1.53', 'groupId': 'BG001'}, {'value': '3.00', 'spread': '1.49', 'groupId': 'BG002'}]}]}, {'title': 'DAD', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '161', 'groupId': 'BG001'}, {'value': '323', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '93.0', 'spread': '10.34', 'groupId': 'BG000'}, {'value': '93.3', 'spread': '9.94', 'groupId': 'BG001'}, {'value': '93.2', 'spread': '10.13', 'groupId': 'BG002'}]}]}, {'title': 'MMSE', 'denoms': [{'units': 'Participants', 'counts': [{'value': '162', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '325', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.1', 'spread': '2.7', 'groupId': 'BG000'}, {'value': '25.5', 'spread': '2.7', 'groupId': 'BG001'}, {'value': '25.3', 'spread': '2.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The ADAS-Cog13 is a rater administered instrument with 13 items assessing areas of cognitive function most typically impaired in Alzheimer's Disease (AD). The A-IADL Questionnaire detects deficits in complex functions (activities necessary to function independently in society). CDR-SB is a semi-structured interview of participants/caregivers to rate participants' cognitive status across 6 domains of functioning. The DAD evaluates basic and instrumental activities of daily living. The MMSE is a measure of global cognition that is widely used for clinical staging of AD.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Not all patients had all baseline measures taken/assessed/collected at baseline.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-24', 'size': 1588277, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-09-10T09:24', 'hasProtocol': True}, {'date': '2024-04-04', 'size': 960976, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-09-10T09:24', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This is a multi-center Phase 3, randomized, double-blind, placebo-controlled, parallel-group study.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 325}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'dispFirstSubmitDate': '2025-05-08', 'completionDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-10-23', 'studyFirstSubmitDate': '2021-02-22', 'resultsFirstSubmitDate': '2025-09-11', 'studyFirstSubmitQcDate': '2021-02-22', 'dispFirstPostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-10-23', 'studyFirstPostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-11-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-05-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Imaging Biomarker Endpoint (Hippocampal Volume)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) hippocampal volume (HV) (uL) as measured by Magnetic Resonance Imaging (MRI). HV atrophy is an early event in AD patients, especially in APOE4/4 homozygotes who show accelerated atrophy compared to APOE3/3 patients with Early AD. HV may be a marker of synaptic loss and neurodegeneration.'}, {'measure': 'Imaging Biomarker Endpoint (Cortical Thickness [Whole Cortex])', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration."}, {'measure': 'Imaging Biomarker Endpoint (Cortical Thickness [Mayo Index])', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration. The Mayo Index refers specifically to the measurement of cortical thickness in the medial temporal lobe."}, {'measure': 'Imaging Biomarker Endpoint (Whole Brain Volume)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in whole brain volume (uL) as measured by Magnetic Resonance Imaging (MRI).'}, {'measure': 'Imaging Biomarker Endpoint (Ventricular Volume)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) ventricular volume (uL) as measured by Magnetic Resonance Imaging (MRI).'}, {'measure': 'Imaging Biomarker Endpoint - DTI in Grey Matter Mean Diffusivity - Bilateral Caudate', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Grey Matter Mean Diffusivity (Bilateral Caudate) as measured by Diffusion Tensor Imaging - Magnetic Resonance Imaging (DTI-MRI). The mean diffusivity (MD) is the average of the three main diffusion values (eigenvalues) obtained from the diffusion tensor imaging (DTI). It is expressed as mm2/s. This unit quantifies the average rate of water diffusion across all directions within a tissue, providing an overall measure of tissue microstructural properties. Lower MD value suggests better maintenance of microstructural integrity of a given brain tissue. Positive treatment effects of ALZ-801 on DTI would present as lower mean diffusivity compared with the placebo group.'}, {'measure': 'Imaging Biomarker Endpoint - DTI in White Matter Mean Diffusivity (Bilateral Fornix)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Bilateral Fornix White Matter Mean Diffusivity as measured by Diffusion Tensor Imaging - Magnetic Resonance Imaging (DTI-MRI). The mean diffusivity (MD) is the average of the three main diffusion values (eigenvalues) obtained from the diffusion tensor imaging (DTI). It is expressed as mm2/s. This unit quantifies the average rate of water diffusion across all directions within a tissue, providing an overall measure of tissue microstructural properties. Lower MD value suggests better maintenance of microstructural integrity of a given brain tissue. Positive treatment effects of ALZ-801 on DTI would present as lower mean diffusivity compared with the placebo group.'}, {'measure': 'Imaging Biomarker Endpoint - White Matter Fractional Anisotropy (Bilateral Fornix)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Bilateral Fornix White Matter Fractional Anisotropy as measured by Diffusion Tensor Imaging - Magnetic Resonance Imaging (DTI-MRI). Fractional anisotropy (FA) is a unitless, scalar value that measures the degree of anisotropic (directional) water diffusion within a voxel, ranging from 0 to 1. A value of 0 indicates perfectly isotropic (equal in all directions) diffusion, while a value of 1 indicates perfectly anisotropic (directional) diffusion. Higher FA value suggests better maintenance of microstructural integrity of a given brain tissue. Positive treatment effects of ALZ-801 on DTI would present as higher FA in the ALZ-801 group compared with the placebo group.'}, {'measure': 'Cognitive Efficacy Endpoint (ADAS-Cog 13) - MCI Subgroup', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks.\n\nThe ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity."}, {'measure': "Cognitive Efficacy Endpoint (ADAS-Cog 13) - Mild Alzheimer's Disease(Mild AD) Subgroup", 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-cog 13) scores at 78 weeks.\n\nThe ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity."}, {'measure': 'A-IADL-W - MCI Subgroup', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.'}, {'measure': 'A-IADL-W - Mild AD Subgroup', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.'}, {'measure': 'CDR-SB - MCI Subgroup', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity."}, {'measure': 'CDR-SB - Mild AD Subgroup', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity."}, {'measure': 'Functional Assessment (DAD) - MCI Subgroup', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.'}, {'measure': 'Functional Assessment (DAD) - Mild AD Subgroup', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.'}, {'measure': 'Global Cognition Assessment (MMSE) - MCI Subgroup', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE is a measure of global cognition that is widely used for clinical staging of Alzheimer's Disease. It consists of 11 domains items for a score range of 0-30 to assess general cognitive function. Higher score on MMSE means better cognitive skills."}, {'measure': 'Global Cognition Assessment (MMSE) - Mild AD Subgroup', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE is a measure of global cognition that is widely used for clinical staging of Alzheimer's Disease. It consists of 11 domains items for a score range of 0-30 to assess general cognitive function. Higher score on MMSE means better cognitive skills."}, {'measure': 'Hippocampal Volume (MCI Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) hippocampal volume (HV) (uL) as measured by Magnetic Resonance Imaging (MRI). HV atrophy is an early event in AD patients, especially in APOE4/4 homozygotes who show accelerated atrophy compared to APOE3/3 patients with Early AD. HV may be a marker of synaptic loss and neurodegeneration.'}, {'measure': 'Hippocampal Volume (Mild AD Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) hippocampal volume (HV) (uL) as measured by Magnetic Resonance Imaging (MRI). HV atrophy is an early event in AD patients, especially in APOE4/4 homozygotes who show accelerated atrophy compared to APOE3/3 patients with Early AD. HV may be a marker of synaptic loss and neurodegeneration.'}, {'measure': 'Cortical Thickness (Whole Cortex) (MCI Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration."}, {'measure': 'Cortical Thickness (Whole Cortex) (Mild AD Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration."}, {'measure': 'Cortical Thickness (Mayo Index) (MCI Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration. The Mayo Index refers specifically to the measurement of cortical thickness in the medial temporal lobe versus the whole cortex."}, {'measure': 'Cortical Thickness (Mayo Index) (Mild AD Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in total (bilateral) cortical thickness (mm) as measured by MRI. Brain MRI studies in Alzheimer's Disease patients show progressive cortical atrophy, reflecting progressive neurodegeneration. The Mayo Index refers specifically to the measurement of cortical thickness in the medial temporal lobe versus the whole cortex."}, {'measure': 'Whole Brain Volume (MCI Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in whole brain volume (uL) as measured by Magnetic Resonance Imaging (MRI).'}, {'measure': 'Whole Brain Volume (Mild AD Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in whole brain volume (uL) as measured by Magnetic Resonance Imaging (MRI).'}, {'measure': 'Ventricular Volume (MCI Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) ventricular volume (uL) as measured by Magnetic Resonance Imaging (MRI).'}, {'measure': 'Ventricular Volume (Mild AD Subgroup)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in total (bilateral) ventricular volume (uL) as measured by Magnetic Resonance Imaging (MRI).'}], 'primaryOutcomes': [{'measure': 'Primary Cognitive Efficacy Endpoint (ADAS-Cog13)', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Alzheimer's Disease Assessment Scale - Cognitive Subscale 13 (ADAS-Cog13) scores.\n\nThe ADAS-Cog13 is a rater administered instrument that was designed to assess the severity of the dysfunction in the cognitive and noncognitive behaviors characteristic of persons with AD. The cognitive subscale of the ADAS-Cog13 consists of 13 items assessing areas of cognitive function most typically impaired in AD: orientation, verbal memory, language, praxis, delayed free recall, digit cancellation. The ADAS-Cog13 scale ranges from 0 to 85. Higher scores indicate greater disease severity."}, {'measure': 'Incidence, Nature, and Severity of Treatment Emergent Adverse Events (TEAE)', 'timeFrame': 'Entire study: approximately 82 weeks. (first dose of study drug until end of Safety Follow-up Visit at 28 +/- 7 days after the last dose (ie, 78-week treatment period plus 4-weeks follow-up after last dose up to total of 82 weeks)', 'description': 'Safety and tolerability as measured by incidence, nature and severity of treatment emergent adverse events (TEAE), serious TEAEs, and TEAEs leading to withdrawal.'}], 'secondaryOutcomes': [{'measure': 'Key Secondary Endpoint (A-IADL-W)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Amsterdam - Instrumental Activities of Daily Living scores calculated using the weighted average method (A-IADL-W score). The A-IADL Questionnaire is a 70-item informant-based computerized questionnaire aimed at detecting deficits in complex functions at the early stages of AD. Instrumental ADL can be described as the activities necessary to function independently in society. These activities include, but are not limited to, cooking, doing finances, and shopping. They are complex everyday tasks, determined by multiple cognitive processes and controlled processing. They can be distinguished from basic ADL, which include basic self-care skills. The A-IADL-W has a score range of 0-100 and is calculated as follows: (sum of all scores / number of questions scored) × 25. For A-IADL-W, higher scores indicates worse functioning or more impairment.'}, {'measure': 'Key Secondary Endpoint (CDR-SB)', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Clinical Dementia Rating - Sum of Boxes (CDR-SB) scores. CDR-SB is a semi-structured interview of participants and their caregivers. Participant's cognitive status is rated across 6 domains of functioning, including memory, orientation, judgment/problem solving, community affairs, home/hobbies, and personal care. Severity score assigned for each of 6 domains; Total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity."}, {'measure': 'Functional Assessment (DAD)', 'timeFrame': 'Baseline to Week 78', 'description': 'Change from baseline in Disability Assessment for Dementia (DAD)scores. The DAD consists of 40 items with a score range of 0-100 to evaluate the basic and instrumental activities of daily living of subjects with dementia. It is administered through an interview with the caregiver. Higher DAD scores indicate less disability or better function.'}, {'measure': 'Global Cognition Assessment (MMSE)', 'timeFrame': 'Baseline to Week 78', 'description': "Change from baseline in Mini-Mental State Examination (MMSE) score. The MMSE is a measure of global cognition that is widely used for clinical staging of Alzheimer's Disease. It consists of 11 domains items for a score range of 0-30 to assess general cognitive function. Higher score on MMSE means better cognitive skills."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Early Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '41015981', 'type': 'DERIVED', 'citation': "Abushakra S, Power A, Watson D, Porsteinsson A, Sabbagh M, MacSweeney E, Cohen S, Boada Rovira M, Doraiswamy PM, Liang E, Flint S, Kesslak JP, McLaine R, Albayrak A, Schaefer J, Yu J, Tolar L, Dickson S, Hey JA, Tolar M. Clinical Efficacy, Safety and Imaging Effects of Oral Valiltramiprosate in APOEepsilon4/epsilon4 Homozygotes with Early Alzheimer's Disease: Results of the Phase III, Randomized, Double-Blind, Placebo-Controlled, 78-Week APOLLOE4 Trial. Drugs. 2025 Nov;85(11):1455-1472. doi: 10.1007/s40265-025-02250-5. Epub 2025 Sep 28."}]}, 'descriptionModule': {'briefSummary': "This study is being conducted to evaluate the safety and efficacy of ALZ-801 in Early Alzheimer's disease (AD) subjects with the APOE4/4 genotype. This is a double-blind, randomized trial with one dose of ALZ-801 compared to placebo.", 'detailedDescription': 'This is a multi-center, double-blind study that will evaluate 265 mg twice daily (BID) of ALZ-801, an oral tablet, over 78 weeks as a treatment for subjects (50-80 years old) with Early AD who are homozygous for the ε4 allele of the apolipoprotein gene (APOE4 homozygous or APOE4/4). The primary efficacy outcome assessment is a measure of cognition (ADAS-cog 13). Additional measures of global and functional impairments will also be assessed. Imaging and soluble biomarkers of AD and neurodegeneration will be measured and a sub-study to evaluate cerebrospinal fluid (CSF) biomarkers is also included.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of MCI or Mild Dementia due to AD consistent with the National Institute on Aging-Alzheimer's Association (NIA-AA) Working Group Criteria.\n* Homozygous for the ε4 allele of the apolipoprotein E gene (APOE4/4).\n* MMSE score at Screening of 22 to 30 (inclusive).\n* CDR - Global score of 0.5 or 1 and CDR Memory Box Score of ≥ 0.5.\n* RBANS delayed memory index score ≤ 85.\n* Evidence of progressive memory loss over the last 12 months per investigator assessment\n\nExclusion Criteria:\n\n* Brain magnetic resonance imaging (MRI) indicative of significant abnormality per central reader, other than AD related atrophy. Computed tomography (CT) scan acceptable for subjects who cannot undergo MRI.\n* Diagnosis of neurodegenerative disorder other than AD.\n* Diagnosis of major depressive disorder (MDD) within one year prior to screening.\n* Currently taking memantine or has taken memantine within 12 weeks prior to the Baseline Visit.\n* History of suicidal behavior within one year prior to screening or has ongoing suicidal ideation.\n* History of seizures, excluding febrile seizures of childhood or a single distant seizure (\\> 5 years).\n* Medically confirmed history of recent cerebral infarct or transient ischemic attack within one year prior to screening."}, 'identificationModule': {'nctId': 'NCT04770220', 'acronym': 'APOLLOE4', 'briefTitle': 'An Efficacy and Safety Study of ALZ-801 in APOE4/4 Early AD Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alzheon Inc.'}, 'officialTitle': "A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy, Safety and Biomarker Effects of ALZ-801 in Subjects With Early Alzheimer's Disease and APOE4/4 Genotype", 'orgStudyIdInfo': {'id': 'ALZ-801-AD301'}, 'secondaryIdInfos': [{'id': 'R01AG065253', 'link': 'https://reporter.nih.gov/quickSearch/R01AG065253', 'type': 'NIH'}, {'id': '2020-005755-20', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ALZ-801', 'description': 'ALZ-801 265 mg BID tablet orally. Subjects will receive placebo in the morning and one tablet of ALZ-801 265 mg tablet in the evening during the first two weeks of the study; thereafter, they will receive a 265 mg tablet twice daily (BID).', 'interventionNames': ['Drug: Experimental: ALZ-801', 'Drug: Placebo Comparator: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects in the placebo treatment arm will receive placebo tablets BID throughout the study', 'interventionNames': ['Drug: Placebo Comparator: Placebo']}], 'interventions': [{'name': 'Experimental: ALZ-801', 'type': 'DRUG', 'otherNames': ['valiltramiprosate', 'tramiprosate prodrug'], 'description': 'ALZ-801 tablet 265 mg once daily in the evening for the first 2 weeks, then ALZ-801 tablet 265 mg BID', 'armGroupLabels': ['ALZ-801']}, {'name': 'Placebo Comparator: Placebo', 'type': 'DRUG', 'description': 'Placebo tablet BID', 'armGroupLabels': ['ALZ-801', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85004', 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