Viewing Study NCT03823404

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Ignite Creation Date: 2025-12-24 @ 7:57 PM
Ignite Modification Date: 2026-01-27 @ 7:07 AM
Study NCT ID: NCT03823404
Status: COMPLETED
Last Update Posted: 2023-02-23
First Post: 2019-01-24
Is Gene Therapy: True
Has Adverse Events: True
Brief Title: GAIN Trial: Phase 2/3 Study of COR388 in Subjects With Alzheimer's Disease
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-01-23', 'type': 'ACTUAL'}}}}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000711153', 'term': 'COR388'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ksmith@quincetx.com', 'phone': '650 722 9813', 'title': 'Dr. Karen Smith', 'organization': 'Quince Therapeutics, Inc.'}, 'certainAgreement': {'otherDetails': 'Individual investigators and/or their associates may publish findings of this study in scientific journals or present them at scientific meetings, provided the Sponsor is given ample opportunity to review any proposed abstract, manuscript, or slide presentation before its submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected from screening through 48 weeks of treatment and 6 weeks of follow up, a total of approximately 60 weeks.', 'eventGroups': [{'id': 'EG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID', 'otherNumAtRisk': 214, 'deathsNumAtRisk': 214, 'otherNumAffected': 139, 'seriousNumAtRisk': 214, 'deathsNumAffected': 5, 'seriousNumAffected': 25}, {'id': 'EG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID', 'otherNumAtRisk': 212, 'deathsNumAtRisk': 212, 'otherNumAffected': 150, 'seriousNumAtRisk': 212, 'deathsNumAffected': 1, 'seriousNumAffected': 20}, {'id': 'EG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID', 'otherNumAtRisk': 217, 'deathsNumAtRisk': 217, 'otherNumAffected': 88, 'seriousNumAtRisk': 217, 'deathsNumAffected': 0, 'seriousNumAffected': 19}], 'otherEvents': [{'term': 'abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 27}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 34}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ALT increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'AST increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 20}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 3}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'amylase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 8}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'lipase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 14}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 7}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numAffected': 28}, {'groupId': 'EG001', 'numAtRisk': 212, 'numAffected': 16}, {'groupId': 'EG002', 'numAtRisk': 217, 'numAffected': 21}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'seriousEvents': [{'term': 'atrial fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'cardiac arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'sinus node dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'gastric perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'gastric ulcer haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'gastrointestinal haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'general physical health deterioration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'non-cardiac chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'cholecystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'cholecystitis acute', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'abdominal abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'clostridium difficile colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'COVID-19 pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ophthalmic herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'septic shock', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'urosepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'clavicle fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'hip fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'multiple fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'subdural haematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'liver function test abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'electrolyte imbalance', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'foot deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'bladder cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'cholangiocarcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'gastrointestinal cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'lung cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'oesophageal carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'prostate cancer stage II', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'cerebral haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': "dementia Alzheimer's type", 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'metabolic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'aggression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'agitation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'anxiety disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'confusional state', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'hallucination', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'intentional self-injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'mental status changes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'psychotic behaviour', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'renal mass', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'acute respiratory failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'dyspnoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 214, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 212, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 217, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '23.7', 'spread': '8.8', 'groupId': 'OG000'}, {'value': '23.4', 'spread': '8.6', 'groupId': 'OG001'}, {'value': '23.6', 'spread': '9.3', 'groupId': 'OG002'}]}]}, {'title': 'Average of Weeks 40/48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '148', 'groupId': 'OG001'}, {'value': '187', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '26.6', 'spread': '12.0', 'groupId': 'OG000'}, {'value': '27.9', 'spread': '11.8', 'groupId': 'OG001'}, {'value': '28.4', 'spread': '12.2', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.0455', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The interim analysis was conducted at significance level of 0.05 and the significance level was adjusted for final analysis.', 'statisticalMethod': 'mixed-effects model for repeated measure', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': "Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'PRIMARY', 'title': "Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '59.9', 'spread': '11.2', 'groupId': 'OG000'}, {'value': '60.1', 'spread': '11.3', 'groupId': 'OG001'}, {'value': '60.4', 'spread': '11.3', 'groupId': 'OG002'}]}]}, {'title': 'Average of Weeks 40/48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '55.4', 'spread': '13.9', 'groupId': 'OG000'}, {'value': '54.4', 'spread': '13.7', 'groupId': 'OG001'}, {'value': '55.5', 'spread': '14.1', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0455', 'groupIds': ['OG000', 'OG001', 'OG002'], 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': "The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.\n\nThe ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Clinical Dementia Rating-Sum of Boxes (CDR-SB)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '211', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.7', 'spread': '2.6', 'groupId': 'OG000'}, {'value': '6.0', 'spread': '2.7', 'groupId': 'OG001'}, {'value': '5.9', 'spread': '2.8', 'groupId': 'OG002'}]}]}, {'title': 'Average of Weeks 40/48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '150', 'groupId': 'OG001'}, {'value': '188', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.2', 'spread': '3.6', 'groupId': 'OG000'}, {'value': '7.2', 'spread': '3.4', 'groupId': 'OG001'}, {'value': '7.4', 'spread': '3.5', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': "Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes 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.\n\nSeverity 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 Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Mini-Mental State Examination (MMSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '18.3', 'spread': '3.3', 'groupId': 'OG000'}, {'value': '18.4', 'spread': '3.2', 'groupId': 'OG001'}, {'value': '18.2', 'spread': '3.3', 'groupId': 'OG002'}]}]}, {'title': 'Average of Week 40/48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '149', 'groupId': 'OG001'}, {'value': '186', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '16.9', 'spread': '5.7', 'groupId': 'OG000'}, {'value': '16.4', 'spread': '5.7', 'groupId': 'OG001'}, {'value': '16.2', 'spread': '5.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'SECONDARY', 'title': 'Neuropsychiatric Inventory (NPI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '216', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.7', 'spread': '8.7', 'groupId': 'OG000'}, {'value': '8.2', 'spread': '11.2', 'groupId': 'OG001'}, {'value': '8.1', 'spread': '10.6', 'groupId': 'OG002'}]}]}, {'title': 'Average of Weeks 40/48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '142', 'groupId': 'OG001'}, {'value': '182', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.7', 'spread': '13.7', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '12.1', 'groupId': 'OG001'}, {'value': '10.4', 'spread': '13.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.\n\nTotal score ranges from 12 to 144; higher scores indicate greater disease severity.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Anti-P. Gingivalis IgG in Serum', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '213', 'groupId': 'OG000'}, {'value': '209', 'groupId': 'OG001'}, {'value': '212', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '191.6', 'spread': '216.8', 'groupId': 'OG000'}, {'value': '202.4', 'spread': '214.0', 'groupId': 'OG001'}, {'value': '193.1', 'spread': '199.5', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '131', 'groupId': 'OG001'}, {'value': '167', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '77.8', 'spread': '123.2', 'groupId': 'OG000'}, {'value': '110.8', 'spread': '184.3', 'groupId': 'OG001'}, {'value': '134.4', 'spread': '201.0', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'Anti-P. gingivalis immunoglobulin G (IgG) in serum\n\nAntibody levels were measured by ELISA and outcome measure are ELISA UNITS (EU)\n\nLower levels represent a pharmacodynamic effect of the drug on its target', 'unitOfMeasure': 'EU', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Magnetic Resonance Imaging', 'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'OG000'}, {'value': '212', 'groupId': 'OG001'}, {'value': '217', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '198', 'groupId': 'OG000'}, {'value': '199', 'groupId': 'OG001'}, {'value': '202', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '1005154', 'spread': '106682', 'groupId': 'OG000'}, {'value': '1008135', 'spread': '105765', 'groupId': 'OG001'}, {'value': '1001711', 'spread': '111145', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '105', 'groupId': 'OG000'}, {'value': '113', 'groupId': 'OG001'}, {'value': '141', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '982782', 'spread': '111888', 'groupId': 'OG000'}, {'value': '987998', 'spread': '102961', 'groupId': 'OG001'}, {'value': '986119', 'spread': '111779', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'Change in magnetic resonance imaging - bilateral whole brain volume\n\nLarger volume may represent effect of the drug on its target', 'unitOfMeasure': 'volume (CM^3)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Periodontal (or Gum) Pocket Depth', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'OG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}, {'value': '77', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '4.04', 'spread': '0.75', 'groupId': 'OG000'}, {'value': '4.03', 'spread': '0.59', 'groupId': 'OG001'}, {'value': '3.74', 'spread': '0.66', 'groupId': 'OG002'}]}]}, {'title': 'Week 48', 'denoms': [{'units': 'Participants', 'counts': [{'value': '39', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '54', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.67', 'spread': '0.92', 'groupId': 'OG000'}, {'value': '3.78', 'spread': '0.71', 'groupId': 'OG001'}, {'value': '3.57', 'spread': '0.61', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Week 48', 'description': 'Periodontal (or gum) pocket depth - pocket depth for only sites with depth \\>= 4mm.\n\nThe primary endpoint was mean change in pocket depth from baseline to the end of the double-blind treatment period for tooth sites with depth ≥ 4mm at any time during the study. Therefore, values presented may be less than 4mm.\n\nLarger measure means worse outcome', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-to-Treat Population'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'FG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'FG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '214'}, {'groupId': 'FG001', 'numSubjects': '212'}, {'groupId': 'FG002', 'numSubjects': '217'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '129'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '163'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '85'}, {'groupId': 'FG001', 'numSubjects': '85'}, {'groupId': 'FG002', 'numSubjects': '54'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '2'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '38'}, {'groupId': 'FG002', 'numSubjects': '8'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '38'}, {'groupId': 'FG001', 'numSubjects': '40'}, {'groupId': 'FG002', 'numSubjects': '35'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Other: Various reasons provided', 'reasons': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '6'}]}]}], 'recruitmentDetails': 'A total of 89 centers worldwide screened subjects and included 57 centers in the United States, 9 centers in the United Kingdom, 8 centers in Spain, 7 centers in Poland, 5 centers in France, and 3 centers in the Netherlands.', 'preAssignmentDetails': "Randomized subjects were stratified by baseline Mini-Mental State Examination (MMSE) score (MMSE ≥12 and ≤18, and MMSE ≥19 and ≤24) and Apolipoprotein E genotype (ApoE4 positive either homozygous or heterozygous vs. all others) to assure balanced distribution of mild and moderate Alzheimer's disease and a balanced distribution of ApoE4 subjects, across treatment arms."}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '214', 'groupId': 'BG000'}, {'value': '212', 'groupId': 'BG001'}, {'value': '217', 'groupId': 'BG002'}, {'value': '643', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'COR388 80 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'BG001', 'title': 'COR388 40 mg BID (Twice Daily)', 'description': 'COR388 capsule: BID'}, {'id': 'BG002', 'title': 'Placebo BID (Twice Daily)', 'description': 'Placebo capsule: BID'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.3', 'spread': '6.9', 'groupId': 'BG000'}, {'value': '68.6', 'spread': '6.9', 'groupId': 'BG001'}, {'value': '69.5', 'spread': '6.9', 'groupId': 'BG002'}, {'value': '69.1', 'spread': '6.9', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Age = age at consent', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '117', 'groupId': 'BG000'}, {'value': '123', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}, {'value': '365', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '89', 'groupId': 'BG001'}, {'value': '92', 'groupId': 'BG002'}, {'value': '278', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '78', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '174', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '187', 'groupId': 'BG002'}, {'value': '549', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '42', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '194', 'groupId': 'BG000'}, {'value': '188', 'groupId': 'BG001'}, {'value': '192', 'groupId': 'BG002'}, {'value': '574', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Netherlands', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '31', 'groupId': 'BG003'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '152', 'groupId': 'BG000'}, {'value': '143', 'groupId': 'BG001'}, {'value': '152', 'groupId': 'BG002'}, {'value': '447', 'groupId': 'BG003'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '54', 'groupId': 'BG003'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '49', 'groupId': 'BG003'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Safety Population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-05-17', 'size': 1335843, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2022-12-23T13:32', 'hasProtocol': True}, {'date': '2021-08-27', 'size': 1354957, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2022-12-23T13:33', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 643}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-22', 'studyFirstSubmitDate': '2019-01-24', 'resultsFirstSubmitDate': '2022-12-23', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-22', 'studyFirstPostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-01-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Anti-P. Gingivalis IgG in Serum', 'timeFrame': 'Baseline to Week 48', 'description': 'Anti-P. gingivalis immunoglobulin G (IgG) in serum\n\nAntibody levels were measured by ELISA and outcome measure are ELISA UNITS (EU)\n\nLower levels represent a pharmacodynamic effect of the drug on its target'}, {'measure': 'Magnetic Resonance Imaging', 'timeFrame': 'Baseline to Week 48', 'description': 'Change in magnetic resonance imaging - bilateral whole brain volume\n\nLarger volume may represent effect of the drug on its target'}, {'measure': 'Periodontal (or Gum) Pocket Depth', 'timeFrame': 'Baseline to Week 48', 'description': 'Periodontal (or gum) pocket depth - pocket depth for only sites with depth \\>= 4mm.\n\nThe primary endpoint was mean change in pocket depth from baseline to the end of the double-blind treatment period for tooth sites with depth ≥ 4mm at any time during the study. Therefore, values presented may be less than 4mm.\n\nLarger measure means worse outcome'}], 'primaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11)", 'timeFrame': 'Baseline to Week 48', 'description': "Alzheimer's Disease Assessment Scale-Cognitive Subscale 11 (ADAS-Cog 11) - Total Score The cognitive subscale of the ADAS (ADAS Cog11) was used as a primary efficacy measure and consists of 11 items assessing areas of function most typically impaired in Alzheimer's disease (AD): orientation, verbal memory, language, and praxis. he scale ranges from 0 to 70, with higher scores indicating greater disease severity."}, {'measure': "Alzheimer's Disease Cooperative Study Group-Activities of Daily Living (ADCS-ADL)", 'timeFrame': 'Baseline to Week 48', 'description': "The Alzheimer's Disease Cooperative Study Activities of Daily Living (ADCS-ADL) Inventory Score is a 23-item inventory.\n\nThe ADCS-ADL measures both basic and instrumental activities of daily living The total ADCS-ADL score ranges from 0 to 78, with lower scores indicating greater disease severity."}], 'secondaryOutcomes': [{'measure': 'Clinical Dementia Rating-Sum of Boxes (CDR-SB)', 'timeFrame': 'Baseline to Week 48', 'description': "Clinical Dementia Rating-Sum of Boxes (CDR-SB) - Sum of Boxes 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.\n\nSeverity score assigned for each of 6 domains; total score (SB) ranges from 0 to 18. Higher scores indicate greater disease severity."}, {'measure': 'Mini-Mental State Examination (MMSE)', 'timeFrame': 'Baseline to Week 48', 'description': 'Change in Mini-Mental State Examination (MMSE) - Total Score Minimum Score - 0 Maximum Score - 30 Higher score means better outcome'}, {'measure': 'Neuropsychiatric Inventory (NPI)', 'timeFrame': 'Baseline to Week 48', 'description': 'Neuropsychiatric Inventory (NPI) - Total Score NPI assesses psychopathology in participants with dementia and other neurologic disorders.\n\nTotal score ranges from 12 to 144; higher scores indicate greater disease severity.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': "This is a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 in subjects with a clinical diagnosis of mild to moderate Alzheimer's disease (AD) dementia.", 'detailedDescription': "This was a randomized, double-blind, placebo-controlled study that assessed the efficacy, safety, and tolerability of 2 dose levels of COR388 oral capsules in subjects with probable Alzheimer's disease (AD) dementia according to the National Institute on Aging-Alzheimer's Association (NIA-AA) criteria. The subject did not have other conditions or brain imaging abnormalities that could explain the symptoms of dementia. All subjects were encouraged to have lumbar punctures (LPs) (during screening, week 24 and week 48) in the absence of medical conditions that could increase the risk of the procedure in the opinion of the Investigator. Cerebrospinal fluid (CSF), saliva, and blood were analyzed for measurements of biomarkers of AD and neuroinflammation, and for the presence of bacterial deoxyribonucleic acid (DNA) of Porphyromonas gingivalis (P. gingivalis). A subset of sites monitored subjects for clinical evidence of periodontitis at baseline, 24 and 48 weeks.\n\nThe study consisted of 3 phases: a screening phase of up to 6 weeks, a treatment phase of up to 48 weeks, and a safety follow-up phase of 6 weeks."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'genderBased': True, 'genderDescription': 'Male and female.', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Subject has probable AD dementia according to the NIA-AA criteria.\n* Subject has an Mini-Mental State Examination (MMSE) score 12 and 24 inclusive at both screening and Visit 2 and a ≤3-point difference between these visits.\n* Subject has brain MRI scan consistent with the diagnosis of AD performed during the screening period. Computed Tomography scan can be used only if the subject has an absolute contraindication for MRI.\n* Subject has a Modified Hachinski score ≤4 at screening.\n* Subjects with background symptomatic therapy with acetylcholine esterase inhibitors, and/or memantine, are allowed as long as the dose has been stable for 90 days prior to screening and no changes are planned during the study.\n* Subject has a primary caregiver willing to accept responsibility for supervising the treatment (e.g., administering study drug) and assessing the condition of the subject throughout the study in accordance with all protocol requirements.\n* Subject has body mass index \\<38 kg/m2 at Screening\n\nKey Exclusion Criteria:\n\n* Subject has imaging consistent with a dementia diagnosis other than AD.\n* Subject has had an increase or restoration of cognition based on medical history.\n* Subject with history or current evidence of major psychiatric illness such as schizophrenia, bipolar disorder, or major depressive disorder that may interfere with the patient's ability to perform the study and all assessments. Note: Mild depression or depressive mood arising in the context of AD are not criteria for exclusion. The use of anti-depressants or the use of anti epileptic medication for non seizure-related treatment is allowed if the dose has remained stable for at least 60 days prior to enrollment.\n* Subject has any of the following laboratory findings at screening:\n\n 1. Alanine aminotransferase \\>3 x upper limit of normal (ULN), aspartate aminotransferase \\>3 x ULN, or history of clinically significant liver disease in the Investigator's judgment.\n 2. Hemoglobin ≤10 g/dl.\n 3. Creatinine clearance (CL) of \\<45 ml/min.\n 4. Poorly controlled diabetes as defined by hemoglobin A1C (HbA1C) \\>8.\n 5. 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