Ignite Creation Date:
2025-12-25 @ 5:06 AM
Ignite Modification Date:
2026-03-17 @ 3:15 AM
Study NCT ID:
NCT02406027
Status:
TERMINATED
Last Update Posted:
2025-04-29
First Post:
2015-03-27
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer's Disease Spectrum
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'C000634126', 'term': 'atabecestat'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Senior Director', 'organization': 'Janssen Research & Development, LLC'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The major limitation of this study was early termination of the study/program by the sponsor, which resulted in small numbers of participants in groups, precluding meaningful interpretation of some of the analyses.'}}, 'adverseEventsModule': {'timeFrame': 'Up to 3 years', 'description': 'Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).', 'eventGroups': [{'id': 'EG000', 'title': 'Double-blind Treatment Phase (Period 1): Placebo', 'description': 'Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.', 'otherNumAtRisk': 35, 'deathsNumAtRisk': 35, 'otherNumAffected': 17, 'seriousNumAtRisk': 35, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 10 mg', 'description': 'Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.', 'otherNumAtRisk': 29, 'deathsNumAtRisk': 29, 'otherNumAffected': 11, 'seriousNumAtRisk': 29, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG002', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 25 mg', 'description': 'Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 14, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG003', 'title': 'Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg', 'description': 'Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.', 'otherNumAtRisk': 15, 'deathsNumAtRisk': 15, 'otherNumAffected': 10, 'seriousNumAtRisk': 15, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG004', 'title': 'OL Phase (Period 2): Placebo to Atabecestat 25 mg', 'description': 'Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.', 'otherNumAtRisk': 14, 'deathsNumAtRisk': 14, 'otherNumAffected': 11, 'seriousNumAtRisk': 14, 'deathsNumAffected': 0, 'seriousNumAffected': 4}, {'id': 'EG005', 'title': 'OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg', 'description': 'Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 12, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG006', 'title': 'OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg', 'description': 'Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.', 'otherNumAtRisk': 22, 'deathsNumAtRisk': 22, 'otherNumAffected': 11, 'seriousNumAtRisk': 22, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Ear Discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Cataract', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dry Eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Eye Pruritus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Keratitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Lacrimation Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Macular Fibrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Vitreous Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Diverticulum Intestinal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Gastrooesophageal Reflux Disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Inguinal Hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Malaise', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Abscess Neck', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Bacterial Blepharitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Candida Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Cystitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Dermatophytosis of Nail', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, 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'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 3}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Upper Respiratory Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Urinary Tract Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 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'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Burns Third Degree', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Craniocerebral Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Thoracic Vertebral Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Wrist Fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Hepatic Enzyme Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Transaminases Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Foot Deformity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Osteoarthritis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Psychotic Disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Calculus Urinary', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Renal Colic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Ureteric Obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}, {'term': 'Menorrhagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 29, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 15, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 14, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 26, 'numAffected': 0}, {'groupId': 'EG006', 'numAtRisk': 22, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 21.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '15', 'groupId': 'OG003'}, {'value': '14', 'groupId': 'OG004'}, {'value': '26', 'groupId': 'OG005'}, {'value': '22', 'groupId': 'OG006'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Phase (Period 1): Placebo', 'description': 'Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 10 mg', 'description': 'Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg', 'description': 'Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG003', 'title': 'Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg', 'description': 'Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.'}, {'id': 'OG004', 'title': 'OL Phase (Period 2): Placebo to Atabecestat 25 mg', 'description': 'Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.'}, {'id': 'OG005', 'title': 'OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg', 'description': 'Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.'}, {'id': 'OG006', 'title': 'OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg', 'description': 'Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.'}], 'classes': [{'title': 'Number of Participants with TEAEs', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '21', 'groupId': 'OG002'}, {'value': '10', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}, {'value': '19', 'groupId': 'OG005'}, {'value': '16', 'groupId': 'OG006'}]}]}, {'title': 'Number of Participants with Serious TEAEs', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '2', 'groupId': 'OG003'}, {'value': '4', 'groupId': 'OG004'}, {'value': '0', 'groupId': 'OG005'}, {'value': '1', 'groupId': 'OG006'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 3 years', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between administration of study drug and up to 3 years that were absent before treatment or that worsened relative to pre-treatment state. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Safety analysis set included all participants who received at least 1 dose of study drug in the study (during Period 1 and 2).'}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Phase (Period 1): Placebo', 'description': 'Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 10 mg', 'description': 'Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg', 'description': 'Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}], 'classes': [{'title': 'CSF ABeta 1-37: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-37: Asymptomatic at Risk: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.9', 'spread': '7.32', 'groupId': 'OG000'}, {'value': '-65.4', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '-90.0', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-37: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '10.09', 'groupId': 'OG000'}]}]}, {'title': 'CSF ABeta 1-37: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-8.8', 'spread': '17.75', 'groupId': 'OG000'}, {'value': '-62.0', 'spread': '11.02', 'groupId': 'OG001'}, {'value': '-65.9', 'spread': '23.16', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-38: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-38: Asymptomatic at Risk: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.3', 'spread': '7.02', 'groupId': 'OG000'}, {'value': '-42.9', 'spread': '17.49', 'groupId': 'OG001'}, {'value': '-83.5', 'spread': '4.84', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-38: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.2', 'spread': '15.41', 'groupId': 'OG000'}]}]}, {'title': 'CSF ABeta 1-38: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.7', 'spread': '16.52', 'groupId': 'OG000'}, {'value': '-58.6', 'spread': '10.21', 'groupId': 'OG001'}, {'value': '-70.4', 'spread': '23.53', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-40: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-40: Asymptomatic at Risk: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.7', 'spread': '6.12', 'groupId': 'OG000'}, {'value': '-46.2', 'spread': '18.22', 'groupId': 'OG001'}, {'value': '-84.6', 'spread': '5.43', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-40: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '17.19', 'groupId': 'OG000'}]}]}, {'title': 'CSF ABeta 1-40: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-14.5', 'spread': '20.48', 'groupId': 'OG000'}, {'value': '-60.7', 'spread': '13.52', 'groupId': 'OG001'}, {'value': '-72.8', 'spread': '22.30', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-42: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-42: Asymptomatic at Risk: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.1', 'spread': '7.81', 'groupId': 'OG000'}, {'value': '-39.6', 'spread': '24.28', 'groupId': 'OG001'}, {'value': '-76.7', 'spread': '11.01', 'groupId': 'OG002'}]}]}, {'title': 'CSF ABeta 1-42: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.0', 'spread': '7.44', 'groupId': 'OG000'}]}]}, {'title': 'CSF ABeta 1-42: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '10', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-15.0', 'spread': '20.51', 'groupId': 'OG000'}, {'value': '-52.5', 'spread': '11.60', 'groupId': 'OG001'}, {'value': '-57.6', 'spread': '31.42', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Double-blind (DB) Day 1 and DB Week 52', 'description': "CSF samples were obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, and ABeta 1-42. ABeta fragments of different length produced by cleavage of amyloid precursor protein (APP) by beta-secretase (BACE) and gamma-secretase complex in brain and excreted into CSF. Participants were classified as asymptomatic at risk: cognitively and functionally normal (Clinical Dementia Rating Scale score \\[CDR\\] =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Double-blind (DB) Safety Analysis Set included all participants (asymptomatic at risk and prodromal at baseline) who received study treatment during Period 1. Here 'n' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point."}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha and sAPP-beta) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Phase (Period 1): Placebo', 'description': 'Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 10 mg', 'description': 'Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg', 'description': 'Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}], 'classes': [{'title': 'CSF sAPP-alpha: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CSF sAPP-alpha: Asymptomatic at Risk: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.7', 'spread': '12.78', 'groupId': 'OG000'}, {'value': '50.1', 'spread': '13.67', 'groupId': 'OG001'}, {'value': '77.8', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'CSF sAPP-alpha: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.9', 'spread': '24.97', 'groupId': 'OG000'}]}]}, {'title': 'CSF sAPP-alpha: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.2', 'spread': '14.01', 'groupId': 'OG000'}, {'value': '60.2', 'spread': '24.03', 'groupId': 'OG001'}, {'value': '85.1', 'spread': '39.35', 'groupId': 'OG002'}]}]}, {'title': 'CSF sAPP-Beta: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CSF sAPP-Beta: Asymptomatic at Risk: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-10.8', 'spread': '8.44', 'groupId': 'OG000'}, {'value': '-57.5', 'spread': '8.06', 'groupId': 'OG001'}, {'value': '-90.8', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'CSF sAPP-Beta: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.4', 'spread': '18.93', 'groupId': 'OG000'}]}]}, {'title': 'CSF sAPP-Beta: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-11.7', 'spread': '14.47', 'groupId': 'OG000'}, {'value': '-63.5', 'spread': '5.19', 'groupId': 'OG001'}, {'value': '-73.0', 'spread': '21.79', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, DB Day 1 and DB Week 52', 'description': "The CSF samples were obtained for measuring levels of different soluble amyloid precursor protein (sAPP) fragments (sAPP-alpha, sAPP-beta). Participants were classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage alzheimer's disease (AD) (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Double-blind (DB) Safety Analysis Set included all participants (asymptomatic at risk and prodromal at baseline) who received study treatment during Period 1. Here 'n' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point."}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Phase (Period 1): Placebo', 'description': 'Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 10 mg', 'description': 'Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg', 'description': 'Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}], 'classes': [{'title': 'Plasma ABeta 1-38: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'Plasma ABeta 1-38:Asymptomatic at Risk: DB Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-9.9', 'spread': '0.83', 'groupId': 'OG000'}]}]}, {'title': 'Plasma ABeta 1-38: Asymptomatic at Risk:DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.3', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Plasma ABeta 1-38: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.0', 'spread': '10.07', 'groupId': 'OG000'}, {'value': '-6.6', 'spread': '13.56', 'groupId': 'OG002'}]}]}, {'title': 'Plasma ABeta 1-38: Prodromal: DB Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '3.0', 'spread': '24.32', 'groupId': 'OG000'}]}]}, {'title': 'Plasma ABeta 1-38: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '20.3', 'spread': '35.48', 'groupId': 'OG000'}]}]}, {'title': 'Plasma ABeta 1-40: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '19.2', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG001'}, {'value': '4.7', 'spread': '40.27', 'groupId': 'OG002'}]}]}, {'title': 'Plasma ABeta 1-40:Asymptomatic at Risk: DB Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-2.3', 'spread': '12.38', 'groupId': 'OG000'}, {'value': '-75.2', 'spread': '10.16', 'groupId': 'OG001'}, {'value': '-82.6', 'spread': '5.59', 'groupId': 'OG002'}]}]}, {'title': 'Plasma ABeta 1-40:Asymptomatic at Risk: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0.0', 'spread': '10.85', 'groupId': 'OG000'}, {'value': '-74.9', 'spread': '6.76', 'groupId': 'OG001'}, {'value': '-80.8', 'spread': '7.60', 'groupId': 'OG002'}]}]}, {'title': 'Plasma ABeta 1-40: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '7', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.9', 'spread': '15.48', 'groupId': 'OG000'}, {'value': '25.8', 'spread': '66.03', 'groupId': 'OG001'}, {'value': '-24.2', 'spread': '41.31', 'groupId': 'OG002'}]}]}, {'title': 'Plasma ABeta 1-40: Prodromal: DB Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '8.6', 'spread': '18.57', 'groupId': 'OG000'}, {'value': '-68.6', 'spread': '8.20', 'groupId': 'OG001'}, {'value': '-82.5', 'spread': '7.38', 'groupId': 'OG002'}]}]}, {'title': 'Plasma ABeta 1-40: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '10.5', 'spread': '17.09', 'groupId': 'OG000'}, {'value': '-70.9', 'spread': '9.24', 'groupId': 'OG001'}, {'value': '-75.3', 'spread': '22.15', 'groupId': 'OG002'}]}]}, {'title': 'Plasma ABeta 1-42: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-5.9', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG000'}]}]}, {'title': 'Plasma ABeta 1-42:Asymptomatic at Risk:DB Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-7.3', 'spread': '9.33', 'groupId': 'OG000'}]}]}, {'title': 'Plasma ABeta 1-42:Asymptomatic at Risk: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-6.0', 'spread': '2.69', 'groupId': 'OG000'}]}]}, {'title': 'Plasma ABeta 1-42: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.9', 'spread': '5.54', 'groupId': 'OG000'}]}]}, {'title': 'Plasma ABeta 1-42: Prodromal: DB Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '15.9', 'spread': '17.15', 'groupId': 'OG000'}]}]}, {'title': 'Plasma ABeta 1-42: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '5.1', 'spread': '17.68', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, DB Day 1, DB Week 24, and DB Week 52', 'description': "Plasma samples were obtained for measuring levels of different ABeta fragments such as ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length were produced by cleavage of APP by beta-secretase (BACE) and gamma-secretase complex in different peripheral tissues, including white blood cells and were measured in plasma. Participants classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Double-blind (DB) Safety Analysis Set included all participants (asymptomatic at risk and prodromal at baseline) who received study treatment during Period 1. Here 'n' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point."}, {'type': 'SECONDARY', 'title': 'Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Tau Protein and Phosphorylated Tau (p-Tau) Protein Level', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}, {'value': '29', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Double-blind Treatment Phase (Period 1): Placebo', 'description': 'Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG001', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 10 mg', 'description': 'Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'OG002', 'title': 'Double-blind Treatment Phase(Period 1): Atabecestat, 25 mg', 'description': 'Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}], 'classes': [{'title': 'CSF Tau Protein: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CSF Tau Protein: Asymptomatic at Risk: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-1.4', 'spread': '14.10', 'groupId': 'OG000'}, {'value': '3.2', 'spread': '15.04', 'groupId': 'OG001'}, {'value': '22.4', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'CSF Tau Protein: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '6.1', 'spread': '6.82', 'groupId': 'OG000'}]}]}, {'title': 'CSF Tau Protein: Prodromal: DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '13.6', 'spread': '45.55', 'groupId': 'OG000'}, {'value': '2.1', 'spread': '13.82', 'groupId': 'OG001'}, {'value': '1.4', 'spread': '8.20', 'groupId': 'OG002'}]}]}, {'title': 'CSF p-Tau Protein: Asymptomatic at Risk: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}, {'title': 'CSF p-Tau Protein: Asymptomatic at Risk:DB Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '1', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-4.6', 'spread': '6.47', 'groupId': 'OG000'}, {'value': '-4.9', 'spread': '1.40', 'groupId': 'OG001'}, {'value': '8.3', 'spread': 'NA', 'comment': 'Here NA signifies that Standard Deviation could not be calculated for a single participant.', 'groupId': 'OG002'}]}]}, {'title': 'CSF p-Tau Protein: Prodromal: DB Day 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '-0.6', 'spread': '7.81', 'groupId': 'OG000'}]}]}, {'title': 'CSF p-Tau Protein: Prodromal: Week 52', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '11', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '2.2', 'spread': '12.93', 'groupId': 'OG000'}, {'value': '-2.7', 'spread': '10.52', 'groupId': 'OG001'}, {'value': '-2.6', 'spread': '8.52', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, DB Day 1 and DB Week 52', 'description': "The CSF samples were obtained for measuring levels of Tau protein and phosphorylated (p)-tau protein. Participants were classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674).", 'unitOfMeasure': 'Percent change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The Double-blind (DB) Safety Analysis Set included all participants (asymptomatic at risk and prodromal at baseline) who received study treatment during Period 1. Here 'n' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure at a given time point."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Double-blind Treatment Phase (Period 1): Placebo', 'description': 'Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'FG001', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 10 mg', 'description': 'Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'FG002', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 25 mg', 'description': 'Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'FG003', 'title': 'Open-label (OL) Phase (Period 2): Placebo to Atabecestat 5 mg', 'description': 'Participants who were receiving placebo in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.'}, {'id': 'FG004', 'title': 'OL Phase (Period 2): Placebo to Atabecestat 25 mg', 'description': 'Participants who were receiving placebo in the Double-blind treatment phase, received 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.'}, {'id': 'FG005', 'title': 'OL Phase (Period 2): Atabecestat 10 mg to Atabecestat 5 mg', 'description': 'Participants who were receiving atabecestat 10 mg in the Double-blind treatment phase, received 5 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.'}, {'id': 'FG006', 'title': 'OL Phase (Period 2): Atabecestat 25 mg to Atabecestat 25 mg', 'description': 'Participants who were receiving atabecestat 25 mg in the Double-blind treatment phase continued to receive 25 mg atabecestat orally, once daily until registration of atabecestat or any safety issue in Open-label phase.'}], 'periods': [{'title': 'Double-blind Treatment Phase (Period 1)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}, {'groupId': 'FG001', 'numSubjects': '29'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Asymptomatic at Risk', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '8'}, {'groupId': 'FG002', 'numSubjects': '6'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Prodromal', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '21'}, {'groupId': 'FG002', 'numSubjects': '20'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '26'}, {'groupId': 'FG002', 'numSubjects': '22'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '2'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Subject Refused Further Study Treatment', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}, {'title': 'Open-label Phase (Period 2)', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '15'}, {'groupId': 'FG004', 'numSubjects': '14'}, {'groupId': 'FG005', 'numSubjects': '26'}, {'groupId': 'FG006', 'numSubjects': '22'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '2'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '2'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '2'}]}, {'type': 'Study Terminated by Sponsor', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '11'}, {'groupId': 'FG004', 'numSubjects': '7'}, {'groupId': 'FG005', 'numSubjects': '24'}, {'groupId': 'FG006', 'numSubjects': '19'}]}, {'type': 'At Spouse Request With PI Agreement', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '1'}, {'groupId': 'FG006', 'numSubjects': '0'}]}, {'type': 'Subject not Compliant to Study Procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}, {'groupId': 'FG006', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Participants who completed their treatment period as described under the parent protocol in study 54861911ALZ2002 (NCT02260674) or any ongoing/future Phase 1b or Phase 2 atabecestat clinical study were enrolled in this study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '90', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Double-blind Treatment Phase (Period 1): Placebo', 'description': 'Participants received placebo matched to atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'BG001', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 10 mg', 'description': 'Participants received 10 milligram (mg) of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'BG002', 'title': 'Double-blind Treatment Phase (Period 1): Atabecestat 25 mg', 'description': 'Participants received 25 mg of atabecestat orally, once daily from Day 1 up to Week 52 in the Double-blind treatment phase.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70.4', 'spread': '5.15', 'groupId': 'BG000'}, {'value': '71.4', 'spread': '7.04', 'groupId': 'BG001'}, {'value': '67.9', 'spread': '8.87', 'groupId': 'BG002'}, {'value': '70', 'spread': '7.06', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}, {'value': '43', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', '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': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '28', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '89', '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': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Hispanic or Latino', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}]}]}, {'title': 'White Non-Hispanic', 'categories': [{'measurements': [{'value': '33', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}, {'value': '83', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'BELGIUM', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'FRANCE', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}, {'title': 'GERMANY', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}]}, {'title': 'NETHERLANDS', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}]}]}, {'title': 'SPAIN', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '37', 'groupId': 'BG003'}]}]}, {'title': 'SWEDEN', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Double-blind safety analysis set included all participants who received study treatment during period 1.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-09-06', 'size': 1905005, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2019-06-25T11:29', 'hasProtocol': True}, {'date': '2018-09-24', 'size': 706524, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2019-06-25T11:29', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2015-07-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2015-03-27', 'resultsFirstSubmitDate': '2019-06-25', 'studyFirstSubmitQcDate': '2015-03-27', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-05', 'studyFirstPostDateStruct': {'date': '2015-04-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs', 'timeFrame': 'Up to 3 years', 'description': 'An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAEs were events between administration of study drug and up to 3 years that were absent before treatment or that worsened relative to pre-treatment state. An serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly.'}], 'secondaryOutcomes': [{'measure': 'Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Amyloid Beta (ABeta) (1-37, 1-38, 1-40, 1-42) Levels', 'timeFrame': 'Baseline, Double-blind (DB) Day 1 and DB Week 52', 'description': "CSF samples were obtained for measuring levels of different ABeta fragments such as ABeta 1-37, ABeta 1-38, ABeta 1-40, and ABeta 1-42. ABeta fragments of different length produced by cleavage of amyloid precursor protein (APP) by beta-secretase (BACE) and gamma-secretase complex in brain and excreted into CSF. Participants were classified as asymptomatic at risk: cognitively and functionally normal (Clinical Dementia Rating Scale score \\[CDR\\] =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674)."}, {'measure': 'Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Soluble Amyloid Precursor Protein (sAPP) Fragments (sAPP-alpha and sAPP-beta) Levels', 'timeFrame': 'Baseline, DB Day 1 and DB Week 52', 'description': "The CSF samples were obtained for measuring levels of different soluble amyloid precursor protein (sAPP) fragments (sAPP-alpha, sAPP-beta). Participants were classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage alzheimer's disease (AD) (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674)."}, {'measure': 'Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Plasma Amyloid Beta (ABeta) (1-38, 1-40, 1-42) Levels', 'timeFrame': 'Baseline, DB Day 1, DB Week 24, and DB Week 52', 'description': "Plasma samples were obtained for measuring levels of different ABeta fragments such as ABeta 1-38, ABeta 1-40, ABeta 1-42. ABeta fragments of different length were produced by cleavage of APP by beta-secretase (BACE) and gamma-secretase complex in different peripheral tissues, including white blood cells and were measured in plasma. Participants classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674)."}, {'measure': 'Double-blind Treatment Phase (Period 1): Percent Change From Baseline in Cerebrospinal Fluid (CSF) Tau Protein and Phosphorylated Tau (p-Tau) Protein Level', 'timeFrame': 'Baseline, DB Day 1 and DB Week 52', 'description': "The CSF samples were obtained for measuring levels of Tau protein and phosphorylated (p)-tau protein. Participants were classified as asymptomatic at risk: cognitively and functionally normal (CDR score =0), but with biomarker pattern consistent with early stage AD (preclinical stage); and prodromal: had some limited cognitive impairment (CDR =0.5), and still functionally normal, with biomarker pattern consistent with early stage (predementia) AD, but had as of yet no dementia (predementia stage). Here, 'Number analyzed=0' signifies that either CSF concentration was below lower limit of quantification for assay or sample was collected under parent study 54861911ALZ2002 (NCT02260674)."}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's Disease", 'JNJ-54861911', 'Placebo'], 'conditions': ['Alzheimer Disease']}, 'referencesModule': {'references': [{'pmid': '32410694', 'type': 'DERIVED', 'citation': "Novak G, Streffer JR, Timmers M, Henley D, Brashear HR, Bogert J, Russu A, Janssens L, Tesseur I, Tritsmans L, Van Nueten L, Engelborghs S. Long-term safety and tolerability of atabecestat (JNJ-54861911), an oral BACE1 inhibitor, in early Alzheimer's disease spectrum patients: a randomized, double-blind, placebo-controlled study and a two-period extension study. Alzheimers Res Ther. 2020 May 14;12(1):58. doi: 10.1186/s13195-020-00614-5."}]}, 'descriptionModule': {'briefSummary': "The purpose of this study is to evaluate the long-term safety and tolerability of JNJ-54861911 in participants in the early Alzheimer's disease (AD \\[progressive brain disease that slowly destroys memory and thinking skills, and eventually even the ability to carry out the simplest tasks\\]) spectrum that have completed a Phase 1b or Phase 2 clinical trial with JNJ-54861911, who are willing to continue their assigned treatment.", 'detailedDescription': "Participants in the early Alzheimer's Disease (AD) spectrum, enrolled in ongoing or future clinical trials with JNJ-54861911 (Phase 1b or Phase 2 studies) will be provided the opportunity to participate in this study upon completion of their treatment period under the parent protocol. The study will consist of a Screening phase and 2 sequential treatment phases (a 12-month double-blind \\[DB\\] treatment phase \\[placebo controlled\\] and an open-label \\[OL\\] phase \\[active\\]) followed by an End-of-Treatment visit. Treatment in OL phase will continue until registration of JNJ-54861911; unless safety issues emerge as determined by the Data Review Committee (DRC) that would warrant termination of the study. Blood and cerebrospinal fluid (CSF) samples will be collected to evaluate the plasma and CSF pharmacokinetics of JNJ-54861911, as well as amyloid beta fragments. Participants' safety will be monitored throughout the study."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants in the early Alzheimer's disease (AD) spectrum at time of enrollment under the parent protocol and according to its inclusion and exclusion criteria, must have very recently completed their treatment in a Phase 1b or Phase 2 JNJ-54861911 clinical study (example \\[e.g.\\], 54861911ALZ2002) under the parent protocol. Enrollment in this study should be completed (Day 1 of double-blind \\[DB\\] treatment phase) as soon as possible, but within 6 weeks, following completion of their treatment period under the parent protocol. If not defined under the parent protocol, completion of the treatment period is defined as having completed all study related procedures of the last visit of the treatment period under the parent protocol. A screening phase of up to 12 weeks may be allowed following written approval of the Sponsor\n* Participant must be willing and able to adhere to the prohibitions and restrictions specified in this protocol\n* Each Participants (or their legally acceptable representative and caregiver depending on disease state and local requirements) must sign an informed consent form (ICF) indicating that he or she understands the purpose of and procedures required for the study and are willing to participate in the study\n* Participants must have a reliable informant (relative, partner, or friend). The informant must be willing to participate as a source of information and has at least weekly contact with the participant (contact can be in-person, via telephone or other audio/visual communication). The informant must have sufficient contact such that the Investigator feels he/she can provide meaningful information about the participant's daily function. If possible, an alternate informant meeting these criteria who can replace the primary informant should be identified prior to randomization\n\nExclusion Criteria:\n\n* Any condition or situation which, in the opinion of the Investigator, may put the participant at significant risk, may confound the study results, or may interfere significantly with participant's participation in the study\n* The use of concomitant medications known to prolong the QT/QTc interval\n* Participant has a history of moderate or severe hepatic impairment or severe renal insufficiency unless completely resolved for more than a year. Participant has clinically significant ongoing hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, hematologic, rheumatologic, psychiatric or metabolic conditions (e.g., requiring frequent monitoring or medication adjustments or is otherwise unstable)"}, 'identificationModule': {'nctId': 'NCT02406027', 'briefTitle': "An Extension Study to Evaluate the Long-Term Safety and Tolerability of JNJ-54861911 in Participants in the Early Alzheimer's Disease Spectrum", 'organization': {'class': 'INDUSTRY', 'fullName': 'Janssen Research & Development, LLC'}, 'officialTitle': "A Randomized, Two-Period, Double-Blind Placebo-Controlled and Open-Label, Multicenter Extension Study to Determine the Long-Term Safety and Tolerability of JNJ-54861911 in Subjects in the Early Alzheimer's Disease Spectrum", 'orgStudyIdInfo': {'id': 'CR106978'}, 'secondaryIdInfos': [{'id': '54861911ALZ2004', 'type': 'OTHER', 'domain': 'Janssen Research & Development, LLC'}, {'id': '2014-004274-41', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Double-blind Treatment Phase: JNJ-54861911, 10 mg', 'description': 'Participants will continue with their current treatment regimen (10 milligram \\[mg\\] of JNJ-54861911) established in the parent study of JNJ-54861911. Participants will receive 10 milligram (mg) of JNJ-54861911 orally, once daily from Day 1 up Week 52 in the DB treatment phase.', 'interventionNames': ['Drug: JNJ-54861911, 10 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Double-blind Treatment Phase: JNJ-54861911, 25 mg', 'description': 'Participants will continue with their current treatment regimen (25 mg of JNJ-54861911) established in the parent study of JNJ-54861911. Participants will receive 25 mg of JNJ-54861911 orally, once daily from Day 1 up Week 52 in the DB treatment phase.', 'interventionNames': ['Drug: JNJ-54861911, 25 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Double-blind Treatment Phase: Placebo', 'description': 'Participants will continue with their current treatment regimen established in the parent study of JNJ-54861911. Participants will receive placebo matching to JNJ-54861911 orally, once daily from Day 1 up Week 52 in the DB treatment phase.', 'interventionNames': ['Drug: Placebo']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open-label Phase: JNJ-54861911, 5 mg', 'description': 'Participants who were receiving JNJ-54861911, 10 mg and placebo in the DB treatment phase, will receive the 5 mg JNJ-54861911 once daily up to end of treatment visit (until registration of JNJ-54861911 or any safety issue) in Open-label phase.', 'interventionNames': ['Drug: JNJ-54861911, 10 mg', 'Drug: JNJ-54861911, 5 mg']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Open-label Phase: JNJ-54861911, 25 mg', 'description': 'Participants who were receiving JNJ-54861911, 25 mg in the DB treatment phase, will continue to receive the same regimen in open-label treatment phase. Participants who were receiving placebo in the DB treatment phase will be randomly assigned to receive 25 mg of JNJ-54861911 once daily up to end of treatment visit (until registration of JNJ-54861911 or any safety issue) in the open-label treatment phase.', 'interventionNames': ['Drug: JNJ-54861911, 25 mg']}], 'interventions': [{'name': 'JNJ-54861911, 10 mg', 'type': 'DRUG', 'description': 'Participants will self-administer JNJ-54861911 tablet, 10 mg (2\\*5 mg), orally, once daily.', 'armGroupLabels': ['Double-blind Treatment Phase: JNJ-54861911, 10 mg', 'Open-label Phase: JNJ-54861911, 5 mg']}, {'name': 'JNJ-54861911, 25 mg', 'type': 'DRUG', 'description': 'Participants will self-administer 1 tablet of JNJ-54861911, containing 25 mg orally, once daily.', 'armGroupLabels': ['Double-blind Treatment Phase: JNJ-54861911, 25 mg', 'Open-label Phase: JNJ-54861911, 25 mg']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Participants will self administer placebo matching to JNJ-54861911 orally once daily.', 'armGroupLabels': ['Double-blind Treatment Phase: Placebo']}, {'name': 'JNJ-54861911, 5 mg', 'type': 'DRUG', 'description': 'Participants will self-administer JNJ-54861911 tablet, 5 mg, orally, once daily.', 'armGroupLabels': ['Open-label Phase: JNJ-54861911, 5 mg']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Ghent', 'country': 'Belgium', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'city': 'Hoboken', 'country': 'Belgium', 'geoPoint': {'lat': 51.17611, 'lon': 4.34844}}, {'city': 'Montpellier', 'country': 'France', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}, {'city': 'Paris', 'country': 'France', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Toulouse', 'country': 'France', 'geoPoint': {'lat': 43.60426, 'lon': 1.44367}}, {'city': 'Essen', 'country': 'Germany', 'geoPoint': {'lat': 51.45657, 'lon': 7.01228}}, {'city': 'Homburg', 'country': 'Germany', 'geoPoint': {'lat': 49.32637, 'lon': 7.33867}}, {'city': 'Lübeck', 'country': 'Germany', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'city': 'Tübingen', 'country': 'Germany', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'city': 'Ulm', 'country': 'Germany', 'geoPoint': {'lat': 48.39841, 'lon': 9.99155}}, {'city': 'Amsterdam', 'country': 'Netherlands', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Barcelona', 'country': 'Spain', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Madrid', 'country': 'Spain', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'city': 'Terrasa Barcelona', 'country': 'Spain'}, {'city': 'Valencia', 'country': 'Spain', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}, {'city': 'Mölndal', 'country': 'Sweden', 'geoPoint': {'lat': 57.6554, 'lon': 12.01378}}, {'city': 'Stockholm', 'country': 'Sweden', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'Janssen Research & Development, LLC Clinical Trial', 'role': 'STUDY_CHAIR', 'affiliation': 'Janssen Research & Development, LLC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Janssen Research & Development, LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}