Viewing Study NCT02972658

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Ignite Creation Date: 2025-12-25 @ 12:10 AM
Ignite Modification Date: 2026-01-04 @ 5:50 AM
Study NCT ID: NCT02972658
Status: TERMINATED
Last Update Posted: 2019-12-03
First Post: 2016-11-21
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia
Sponsor:
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Raw JSON

{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D024801', 'term': 'Tauopathies'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000608388', 'term': 'lanabecestat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'information.center@astrazeneca.com', 'phone': '877-240-9479', 'title': 'AstraZeneca Information Center', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': 'The sponsor shall review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days from the time submitted to the sponsor for review. Investigator shall delay publication of their results of the study until the results of the multi-center study are published or presented, provided the multi-center results are published within 24 months of the termination.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was stopped after an independent assessment concluded that the feeder study AZES was futile. Because of this, the originally planned delayed-start analysis for this study was not performed.'}}, 'adverseEventsModule': {'timeFrame': 'Up To 156 Weeks', 'description': 'All AZFD participants who received at least one dose of study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.', 'otherNumAtRisk': 76, 'deathsNumAtRisk': 76, 'otherNumAffected': 11, 'seriousNumAtRisk': 76, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.', 'otherNumAtRisk': 139, 'deathsNumAtRisk': 139, 'otherNumAffected': 23, 'seriousNumAtRisk': 139, 'deathsNumAffected': 0, 'seriousNumAffected': 8}, {'id': 'EG002', 'title': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 8, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 5}, {'id': 'EG003', 'title': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.', 'otherNumAtRisk': 131, 'deathsNumAtRisk': 131, 'otherNumAffected': 17, 'seriousNumAtRisk': 131, 'deathsNumAffected': 1, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 10, 'numAffected': 8}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 7, 'numAffected': 5}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 8, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 8, 'numAffected': 5}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'seriousEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Colitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Enteritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Oesophageal motility disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Small intestinal obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Diverticulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Influenza', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Femoral neck fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Femur fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Radiation proctitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Electrocardiogram repolarisation abnormality', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Weight decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Musculoskeletal chest pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Breast cancer in situ', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Breast cancer metastatic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Laryngeal squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Optic neuritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}, {'term': 'Neuropsychiatric symptoms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 76, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 139, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 74, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 131, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 21.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': "Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG001', 'title': 'AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG002', 'title': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}, {'id': 'OG003', 'title': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}], 'classes': [{'categories': [{'measurements': [{'value': '9.61', 'spread': '1.60', 'groupId': 'OG000'}, {'value': '9.25', 'spread': '1.21', 'groupId': 'OG001'}, {'value': '8.41', 'spread': '1.65', 'groupId': 'OG002'}, {'value': '10.41', 'spread': '1.25', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': 'ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure. Feeder study AZES was stopped for futility, the original Delayed Start analysis was replaced with MMRM analysis and no comparisons between treatment groups were made.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '129', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG001', 'title': 'AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG002', 'title': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}, {'id': 'OG003', 'title': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-9.19', 'spread': '1.47', 'groupId': 'OG000'}, {'value': '-8.45', 'spread': '1.10', 'groupId': 'OG001'}, {'value': '-7.37', 'spread': '1.51', 'groupId': 'OG002'}, {'value': '-7.48', 'spread': '1.14', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': "The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADCS-iADL measure.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Functional Activities Questionnaire (FAQ) Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '137', 'groupId': 'OG001'}, {'value': '74', 'groupId': 'OG002'}, {'value': '130', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG001', 'title': 'AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG002', 'title': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}, {'id': 'OG003', 'title': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.28', 'spread': '0.98', 'groupId': 'OG000'}, {'value': '7.09', 'spread': '0.76', 'groupId': 'OG001'}, {'value': '6.73', 'spread': '1.01', 'groupId': 'OG002'}, {'value': '6.91', 'spread': '0.79', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': "FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now =1; Never did but could do now =0; Normal =0; Has difficulty but does by self =1; Requires assistance =2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for FAQ score.'}, {'type': 'SECONDARY', 'title': "Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score", 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '123', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG001', 'title': 'AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG002', 'title': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}, {'id': 'OG003', 'title': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-18.85', 'spread': '2.58', 'groupId': 'OG000'}, {'value': '-17.57', 'spread': '1.97', 'groupId': 'OG001'}, {'value': '-15.37', 'spread': '2.76', 'groupId': 'OG002'}, {'value': '-18.37', 'spread': '2.09', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': 'The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for iADRS.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline on the Mini-Mental Status Examination (MMSE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG001', 'title': 'AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG002', 'title': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}, {'id': 'OG003', 'title': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.84', 'spread': '0.71', 'groupId': 'OG000'}, {'value': '-5.73', 'spread': '0.54', 'groupId': 'OG001'}, {'value': '-4.72', 'spread': '0.72', 'groupId': 'OG002'}, {'value': '-5.25', 'spread': '0.56', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': "The MMSE is an instrument used to assess a participant's cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.", 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for MMSE.'}, {'type': 'SECONDARY', 'title': 'Change From Baseline Analysis on the ADAS-Cog13', 'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'OG000'}, {'value': '139', 'groupId': 'OG001'}, {'value': '75', 'groupId': 'OG002'}, {'value': '131', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG001', 'title': 'AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) received Lanabecestat 20 mg in AZFD.'}, {'id': 'OG002', 'title': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}, {'id': 'OG003', 'title': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) received Lanabecestat 50 mg in AZFD.'}], 'classes': [{'categories': [{'measurements': [{'value': '16.64', 'spread': '3.45', 'groupId': 'OG000'}, {'value': '12.40', 'spread': '2.25', 'groupId': 'OG001'}, {'value': '16.79', 'spread': '2.47', 'groupId': 'OG002'}, {'value': '15.05', 'spread': '2.06', 'groupId': 'OG003'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'AZES Baseline through AZFD Week 52', 'description': 'ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'All AZFD participants who received at least one dose of study drug and have baseline and at least one post-baseline data for ADAS-Cog13 measure.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.'}, {'id': 'FG001', 'title': 'AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.'}, {'id': 'FG002', 'title': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.'}, {'id': 'FG003', 'title': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '131'}]}, {'type': 'Received at Least 1 Dose of Study Drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '139'}, {'groupId': 'FG002', 'numSubjects': '74'}, {'groupId': 'FG003', 'numSubjects': '131'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'comment': '1 participant was incorrectly marked as "Completed" rather than study terminated by Sponsor.', 'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '76'}, {'groupId': 'FG001', 'numSubjects': '138'}, {'groupId': 'FG002', 'numSubjects': '75'}, {'groupId': 'FG003', 'numSubjects': '131'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Other-determined by Investigator', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '2'}]}, {'type': 'Progressive Disease', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '6'}]}, {'type': 'Withdrawal due to Caregiver Circumstance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}, {'type': 'Sponsor Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '70'}, {'groupId': 'FG001', 'numSubjects': '127'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '119'}]}]}], 'recruitmentDetails': 'Participants who completed feeder study \\[AZES (NCT02245737)\\] were enrolled in this study.', 'preAssignmentDetails': 'Participants who were randomized in Study AZES to either 20 milligrams (mg) or 50 mg of lanabecestat continued on the treatment allocation from the feeder study. Participants randomized to placebo in Study AZES were randomized in a blinded fashion, 1:1 ratio, to either lanabecestat 20 mg or 50 mg daily (QD), administered orally.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '76', 'groupId': 'BG000'}, {'value': '139', 'groupId': 'BG001'}, {'value': '75', 'groupId': 'BG002'}, {'value': '131', 'groupId': 'BG003'}, {'value': '421', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.'}, {'id': 'BG001', 'title': 'AZES Lanabecestat 20 mg/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.'}, {'id': 'BG002', 'title': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.'}, {'id': 'BG003', 'title': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.7', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '69.8', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '71.1', 'spread': '6.6', 'groupId': 'BG002'}, {'value': '70.1', 'spread': '6.7', 'groupId': 'BG003'}, {'value': '70.3', 'spread': '7.0', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': 'Details are from AZES baseline.', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}, {'value': '75', 'groupId': 'BG003'}, {'value': '226', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '63', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '56', 'groupId': 'BG003'}, {'value': '195', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '18', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '115', 'groupId': 'BG001'}, {'value': '54', 'groupId': 'BG002'}, {'value': '114', 'groupId': 'BG003'}, {'value': '345', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '16', 'groupId': 'BG003'}, {'value': '56', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '64', 'groupId': 'BG000'}, {'value': '104', 'groupId': 'BG001'}, {'value': '51', 'groupId': 'BG002'}, {'value': '106', 'groupId': 'BG003'}, {'value': '325', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '9', 'groupId': 'BG003'}, {'value': '37', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Puerto Rico', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'Romania', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}]}]}, {'title': 'Hungary', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}]}, {'title': 'United States', 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}, {'title': 'United Kingdom', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '46', 'groupId': 'BG004'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '21', 'groupId': 'BG003'}, {'value': '60', 'groupId': 'BG004'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}, {'title': 'South Korea', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '13', 'groupId': 'BG004'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}]}, {'title': 'Poland', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '34', 'groupId': 'BG004'}]}]}, {'title': 'France', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '33', 'groupId': 'BG004'}]}]}, {'title': 'Australia', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '30', 'groupId': 'BG004'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': "ADAS-Cog13 (13-item Alzheimer's Disease Assessment Scale)", 'classes': [{'categories': [{'measurements': [{'value': '27.9', 'spread': '8.3', 'groupId': 'BG000'}, {'value': '29.6', 'spread': '7.8', 'groupId': 'BG001'}, {'value': '27.0', 'spread': '7.5', 'groupId': 'BG002'}, {'value': '27.1', 'spread': '7.5', 'groupId': 'BG003'}, {'value': '27.9', 'spread': '7.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'description': "ADAS-Cog13, a 13-item rating scale, measured the severity of cognitive dysfunction in persons with Alzheimer's disease (AD). Scores ranged from 0 to 85, with a higher score indicating worse cognitive functioning. Details are from AZES baseline.", 'unitOfMeasure': 'Units on a Scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All randomized participants who received study drug.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-02-06', 'size': 974925, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-04T02:01', 'hasProtocol': True}, {'date': '2018-08-20', 'size': 3637512, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-04T02:02', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 421}}, 'statusModule': {'whyStopped': 'As the feeder study (AZES) was stopped for futility after an independent assessment, this trial was also stopped.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-19', 'studyFirstSubmitDate': '2016-11-21', 'resultsFirstSubmitDate': '2019-06-11', 'studyFirstSubmitQcDate': '2016-11-21', 'lastUpdatePostDateStruct': {'date': '2019-12-03', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-06-11', 'studyFirstPostDateStruct': {'date': '2016-11-23', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-07-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Change From Baseline Analysis on the 13-item Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-Cog13)", 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': 'ADAS-Cog13 (13-item version of ADAS-Cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, apolipoprotein E4 (APOE4) status, acetylcholinesterase inhibitor (AChEI) use at baseline, age at baseline, and pooled country.'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline Analysis on the Alzheimer´s Disease Cooperative Study Activities of Daily Living Inventory Instrumental Items (ADCS-iADL)', 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': "The ADCS-ADL is a 23-item inventory developed as a rater-administered questionnaire answered by the participant's caregiver. The ADCS-ADL measures both basic and instrumental activities of daily living by participants. The range for the ADCS-iADL is 0-59 with higher scores reflecting better performance. LS Mean was determined by MMRM with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country."}, {'measure': 'Change From Baseline on the Functional Activities Questionnaire (FAQ) Score', 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': "FAQ is a 10-item, caregiver-questionnaire and was administered to the study partner and asked to rate the participant's ability to perform a variety of activities ranging from writing checks, assembling tax records, shopping, playing games, food preparation, traveling, keeping appointments, traveling out of neighborhood, keeping track of current events and understanding media. FAQ total score was calculated by adding the scores from each of the 10 items. Each activity is rated on a scale from 0 to 3 (Never did and would have difficulty now =1; Never did but could do now =0; Normal =0; Has difficulty but does by self =1; Requires assistance =2; Dependent =3). FAQ scale is 0 to 30, with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country."}, {'measure': "Change From Baseline on the Integrated Alzheimer's Disease Rating Scale (iADRS) Score", 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': 'The iADRS is a composite that measures both cognition and function. The iADRS comprises scores form the ADAS- Cog and the ADCS-iADL. The iADRS is calculated as a linear combination of the total scores of the ADAS-Cog13 (score range 0 to 85 with higher scores reflecting worse performance) and the ADCS-iADL (score range from 0-59 with higher scores reflecting better performance). The iADRS score ranges from 0 to 144 with higher scores indicating greater impairment. LS Mean was determined by MMRM with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.'}, {'measure': 'Change From Baseline on the Mini-Mental Status Examination (MMSE)', 'timeFrame': 'AZES Baseline through AZFD Week 26', 'description': "The MMSE is an instrument used to assess a participant's cognitive function. The MMSE assesses orientation to time and place, immediate and delayed recall of words, attention and calculation, language (naming, comprehension and repetition), and spatial ability (copying a figure). The range for MMSE total Score is 0 to 30, with a higher score indicating better cognitive performance. LS Mean was determined by MMRM methodology with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country."}, {'measure': 'Change From Baseline Analysis on the ADAS-Cog13', 'timeFrame': 'AZES Baseline through AZFD Week 52', 'description': 'ADAS-cog13 (13-item ADAS cog) is a psychometric instrument that evaluates word recall, ability to follow commands, constructional praxis, naming, ideational praxis, orientation, word recognition, memory, comprehension of spoken language, word-finding, and language ability, with a measure of delayed word recall and concentration/ distractibility. The total score of the 13-item scale ranges from 0 to 85, with an increase in score indicating cognitive worsening. Least Squares (LS) mean was determined by mixed-model repeated measures (MMRM) model with factors for treatment, visit, treatment\\*visit, baseline efficacy score, baseline efficacy score-by-visit interaction, disease status at baseline, APOE4 status, AChEI use at baseline, age at baseline, and pooled country.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's Disease", 'Dementia', 'Brain Diseases', 'Neurodegenerative Diseases', 'Central Nervous System Diseases', 'Nervous System Diseases', 'Mental Disorders', 'Delirium, Dementia, Amnestic, Cognitive Disorders', 'Tauopathies', 'Memory', 'Amyloid'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.lillytrialguide.com/en-US/studies/alzheimer-s/AZFD#?postal=', 'label': "Click here for more information about this study: A Study of LY3314814 in Early Alzheimer's Disease Dementia"}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=16557&attachmentIdentifier=a046bc93-718a-4179-8f30-4b65da56a317&fileName=CSP_NCT02972658.pdf&versionIdentifier=', 'label': 'CSP'}, {'url': 'https://filehosting-v2.pharmacm.com/api/Attachment/Download?tenantId=80217111&parentIdentifier=16557&attachmentIdentifier=a6ee5d0a-4796-4efd-b082-e84fbcbac489&fileName=SAP_NCT02972658.pdf&versionIdentifier=', 'label': 'SAP'}]}, 'descriptionModule': {'briefSummary': "This study is an extension of study I8D-MC-AZES (NCT02245737), the AMARANTH study. The purpose of this study is to evaluate the effectiveness of the study drug lanabecestat in participants with early Alzheimer's disease dementia at the time of entry into study I8D-MC-AZES.", 'detailedDescription': 'Study AZFD was designed to be integrated with 104-week study AZES to form a Delayed-Start study (Study AZES-FD). Study AZES-FD was to be used to test the hypothesis that participants originally randomized to receive placebo in the double-blind feeder study AZES and switched to LY3314814 at the start of study AZFD did not "catch up" on the Alzheimer\'s Disease Assessment Scale-Cognitive Subscale (ADAS-Cog13) at Week 26 of study AZFD to participants originally randomized to receive LY3314814 in the double-blind feeder study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants previously enrolled in AMARANTH (NCT02245737) who meet eligibility criteria for delayed-start I8D-MC-AZFD.\n\nExclusion Criteria:\n\n* Participants who participate in AMARANTH (NCT02245737) who develop new conditions precluding them from enrolling into I8D-MC-AZFD.'}, 'identificationModule': {'nctId': 'NCT02972658', 'briefTitle': "A Study of Lanabecestat (LY3314814) in Early Alzheimer's Disease Dementia", 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': "A Randomized, Double-Blind, Delayed-Start Study of LY3314814 (AZD3293) in Early Alzheimer's Disease Dementia (Extension of Study AZES, The AMARANTH Study)", 'orgStudyIdInfo': {'id': '16557'}, 'secondaryIdInfos': [{'id': 'I8D-MC-AZFD', 'type': 'OTHER', 'domain': 'Eli Lilly and Company'}, {'id': '2016-003440-36', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg', 'description': 'Participants who received Lanabecestat 20 mg in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.', 'interventionNames': ['Drug: Lanabecestat']}, {'type': 'EXPERIMENTAL', 'label': 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'description': 'Participants who received Lanabecestat 50 mg in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.', 'interventionNames': ['Drug: Lanabecestat']}, {'type': 'EXPERIMENTAL', 'label': 'AZES Placebo/AZFD Lanabecestat 20 mg', 'description': 'Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 20 mg.', 'interventionNames': ['Drug: Lanabecestat']}, {'type': 'EXPERIMENTAL', 'label': 'AZES Placebo/AZFD Lanabecestat 50 mg', 'description': 'Participants who received placebo in the feeder study (AZES) were randomized to receive Lanabecestat 50 mg.', 'interventionNames': ['Drug: Lanabecestat']}], 'interventions': [{'name': 'Lanabecestat', 'type': 'DRUG', 'otherNames': ['LY3314814', 'AZD3293'], 'description': 'Administered orally', 'armGroupLabels': ['AZES Lanabecestat 20 milligrams (mg)/AZFD Lanabecestat 20 mg', 'AZES Lanabecestat 50 mg/AZFD Lanabecestat 50 mg', 'AZES Placebo/AZFD Lanabecestat 20 mg', 'AZES Placebo/AZFD Lanabecestat 50 mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 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