Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2026-03-01 @ 4:46 PM
Study NCT ID:
NCT02585934
Status:
COMPLETED
Last Update Posted:
2018-12-05
First Post:
2015-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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': 'C548140', 'term': '3-benzenesulfonyl-8-piperazin-1-ylquinoline'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ilise.lombardo@axovant.com', 'phone': '646-822-8626', 'title': 'Ilise Lombardo, MD', 'organization': 'Axovant Sciences, Inc.'}, 'certainAgreement': {'otherDetails': 'All proposed manuscripts, publications or abstracts must be reviewed and approved by the Sponsor 60 days prior to submission for publication. All confidential information identified by the Sponsor must be deleted prior to submission.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Screening through post treatment (up to 33 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'RVT-101 Treatment', 'description': 'RVT-101 adjunct to 5 mg or 10 mg donepezil\n\nRVT-101: once daily, oral, 35 mg tablets for up to 27 weeks', 'otherNumAtRisk': 656, 'deathsNumAtRisk': 656, 'otherNumAffected': 191, 'seriousNumAtRisk': 656, 'deathsNumAffected': 3, 'seriousNumAffected': 40}, {'id': 'EG001', 'title': 'Placebo Treatment', 'description': 'Placebo adjunct to 5 mg or 10 mg donepezil\n\nPlacebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks', 'otherNumAtRisk': 651, 'deathsNumAtRisk': 651, 'otherNumAffected': 166, 'seriousNumAtRisk': 651, 'deathsNumAffected': 2, 'seriousNumAffected': 44}, {'id': 'EG002', 'title': 'Screening Period', 'description': 'Participants screened (0-4 weeks) prior to entering to the first dose of single-blind study medication (ie, prior to the Run-In period)', 'otherNumAtRisk': 2173, 'deathsNumAtRisk': 2173, 'otherNumAffected': 0, 'seriousNumAtRisk': 2173, 'deathsNumAffected': 1, 'seriousNumAffected': 12}, {'id': 'EG003', 'title': 'Run-In Period', 'description': 'Placebo adjunct to 5 mg or 10 mg donepezil\n\nPlacebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet (for 3 weeks)', 'otherNumAtRisk': 1470, 'deathsNumAtRisk': 1470, 'otherNumAffected': 0, 'seriousNumAtRisk': 1470, 'deathsNumAffected': 1, 'seriousNumAffected': 14}, {'id': 'EG004', 'title': 'RVT-101 Post-Treatment', 'description': 'Subjects reported adverse events after completing the treatment period.\n\nThe Post-Treatment period - defined as up to 30 days post-last-dose', 'otherNumAtRisk': 656, 'deathsNumAtRisk': 656, 'otherNumAffected': 0, 'seriousNumAtRisk': 656, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG005', 'title': 'Placebo Post-Treatment', 'description': 'Subjects reported adverse events after completing the treatment period.\n\nThe Post-Treatment period - defined as up to 30 days post-last-dose', 'otherNumAtRisk': 651, 'deathsNumAtRisk': 651, 'otherNumAffected': 0, 'seriousNumAtRisk': 651, 'deathsNumAffected': 1, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 37}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 29}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 25}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 26}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 23}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 19}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 12}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 13}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 17}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Back pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 11}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 7}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Cerebrovascular Accident', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischaemic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Ischaemic stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dementia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypoxic-ischaemic encephalopathy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lethargy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Status epilepticus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acoustic neuroma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Breast cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hepatocellular carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Lung neoplasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Malignant melanoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Meningioma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 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0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Squamous cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Uterine leiomyoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Atrial Fibrillation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, 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'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Poor peripheral circulation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Musculoskeletal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Acute kidney injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Humerus fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Cardiac failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 651, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 2173, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 1470, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 656, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 651, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 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Both the frequency and the severity of each behavior are determined.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT Population at both timepoints'}, {'type': 'SECONDARY', 'title': 'ADAS-Cog-13 Score Change From Baseline to Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '583', 'groupId': 'OG000'}, {'value': '576', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'RVT-101', 'description': 'RVT-101 adjunct to 5 mg or 10 mg donepezil\n\nRVT-101: once daily, oral, 35 mg tablets'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Placebo adjunct to 5 mg or 10 mg donepezil\n\nPlacebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet'}], 'classes': [{'categories': [{'measurements': [{'value': '0.26', 'spread': '0.233', 'groupId': 'OG000'}, {'value': '0.64', 'spread': '0.236', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.2472', 'groupIds': ['OG000', 'OG001'], 'paramType': 'least square mean difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-0.38', 'ciLowerLimit': '-1.03', 'ciUpperLimit': '0.27', 'pValueComment': 'the threshold for statistical significance was p=0.05', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Statistical Method: Mixed model for repeated measures'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline, 24 weeks', 'description': '13-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 additional items: delayed word recall and total digit cancellation. Scores for the ADAS-Cog-13 range from 0 to 85 with higher scores indicating greater dysfunction.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'ITT at both timepoints'}, {'type': 'SECONDARY', 'title': 'Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma', 'denoms': [{'units': 'Participants', 'counts': [{'value': '656', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'RVT-101', 'description': 'RVT-101 adjunct to 5 mg or 10 mg donepezil\n\nRVT-101: once daily, oral, 35 mg tablets for up to 27 weeks'}], 'classes': [{'title': 'Summary Statistics at Week 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '563', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '201.11', 'groupId': 'OG000', 'lowerLimit': '191.88', 'upperLimit': '210.78'}]}]}, {'title': 'Summary Statistics at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '579', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '170.95', 'groupId': 'OG000', 'lowerLimit': '164.40', 'upperLimit': '177.76'}]}]}, {'title': 'Summary Statistics at Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '454', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '198.69', 'groupId': 'OG000', 'lowerLimit': '189.36', 'upperLimit': '208.48'}]}]}, {'title': 'Summary Statistics at Week 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '562', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '193.36', 'groupId': 'OG000', 'lowerLimit': '184.60', 'upperLimit': '202.53'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Week 6, Week 12, Week 18, Week 24', 'description': 'Measurement collected at timepoints Week 6, Week 12, Week 18, and Week 24', 'unitOfMeasure': 'ng/mL', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'PK population at specified timepoints: Week 6, Week 12, Week 18, and Week 24'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'RVT-101', 'description': 'RVT-101 adjunct to 5 mg or 10 mg donepezil\n\nRVT-101: once daily, oral, 35 mg tablets for up to 27 weeks'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Placebo adjunct to 5 mg or 10 mg donepezil\n\nPlacebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '661'}, {'groupId': 'FG001', 'numSubjects': '654'}]}, {'type': 'Safety Population', 'comment': 'The Safety population included subjects who took at least 1 dose of double-blind study drug', 'achievements': [{'groupId': 'FG000', 'numSubjects': '656'}, {'groupId': 'FG001', 'numSubjects': '651'}]}, {'type': 'Intent to Treat (ITT)', 'comment': 'Subjects took at least 1 dose of double-blind study drug and had at least 1 post-baseline assessment', 'achievements': [{'groupId': 'FG000', 'numSubjects': '643'}, {'groupId': 'FG001', 'numSubjects': '633'}]}, {'type': 'Per Protocol (PP)', 'comment': 'Subjects in the ITT population who had no major protocol violations', 'achievements': [{'groupId': 'FG000', 'numSubjects': '603'}, {'groupId': 'FG001', 'numSubjects': '582'}]}, {'type': 'COMPLETED', 'comment': 'Subjects in the ITT population who completed the study', 'achievements': [{'groupId': 'FG000', 'numSubjects': '592'}, {'groupId': 'FG001', 'numSubjects': '581'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}, {'groupId': 'FG001', 'numSubjects': '73'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '11'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '21'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Caregiver Withdrew Consent', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '7'}]}, {'type': 'Sponsor Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Another Reason', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '5'}]}]}], 'preAssignmentDetails': '2173 participants signed consent and were screened for participation. Of these, 1470 entered a 3-week single-blind placebo run-in period with treatment with placebo qd + stable dose of donepezil 5 or 10 mg qd. There was an overlap between the participants from the run-in period and the participants that were randomized during the treatment period.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'RVT-101', 'description': 'RVT-101 adjunct to 5 mg or 10 mg donepezil\n\nRVT-101: once daily, oral, 35 mg tablets for up to 27 weeks'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Placebo adjunct to 5 mg or 10 mg donepezil\n\nPlacebo: once daily, oral, pill manufactured to match RVT-101 35 mg tablet for up to 27 weeks'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '72.7', 'groupId': 'BG000', 'lowerLimit': '50', 'upperLimit': '85'}, {'value': '72.5', 'groupId': 'BG001', 'lowerLimit': '50', 'upperLimit': '86'}, {'value': '72.6', 'groupId': 'BG002', 'lowerLimit': '50', 'upperLimit': '86'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Age, Customized', 'classes': [{'title': '< 74 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '309', 'groupId': 'BG000'}, {'value': '312', 'groupId': 'BG001'}, {'value': '621', 'groupId': 'BG002'}]}]}, {'title': '>/= 74 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '334', 'groupId': 'BG000'}, {'value': '321', 'groupId': 'BG001'}, {'value': '655', 'groupId': 'BG002'}]}]}, {'title': '< 65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '98', 'groupId': 'BG000'}, {'value': '97', 'groupId': 'BG001'}, {'value': '195', 'groupId': 'BG002'}]}]}, {'title': '>/=65 years', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '545', 'groupId': 'BG000'}, {'value': '536', 'groupId': 'BG001'}, {'value': '1081', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '386', 'groupId': 'BG000'}, {'value': '394', 'groupId': 'BG001'}, {'value': '780', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '257', 'groupId': 'BG000'}, {'value': '239', 'groupId': 'BG001'}, {'value': '496', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '120', 'groupId': 'BG000'}, {'value': '108', 'groupId': 'BG001'}, {'value': '228', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '518', 'groupId': 'BG000'}, {'value': '519', 'groupId': 'BG001'}, {'value': '1037', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'denoms': [{'units': 'Participants', 'counts': [{'value': '643', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1276', 'groupId': 'BG002'}]}], 'categories': [{'title': 'White', 'measurements': [{'value': '595', 'groupId': 'BG000'}, {'value': '592', 'groupId': 'BG001'}, {'value': '1187', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Others', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Not Applicable', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'BMI', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '642', 'groupId': 'BG000'}, {'value': '633', 'groupId': 'BG001'}, {'value': '1275', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '26.4', 'groupId': 'BG000', 'lowerLimit': '17.2', 'upperLimit': '56.3'}, {'value': '26.5', 'groupId': 'BG001', 'lowerLimit': '15.2', 'upperLimit': '45.3'}, {'value': '26.4', 'groupId': 'BG002', 'lowerLimit': '15.2', 'upperLimit': '56.3'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'FULL_RANGE', 'populationDescription': 'Data was missing for one subject'}], 'populationDescription': 'ITT population'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-04-13', 'size': 2597849, 'label': 'Study Protocol: Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-12T11:48', 'hasProtocol': True}, {'date': '2017-08-09', 'size': 1273157, 'label': 'Statistical Analysis Plan: Statistical Analysis Plan Document', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-12T11:52', 'hasProtocol': False}, {'date': '2017-09-19', 'size': 716599, 'label': 'Statistical Analysis Plan: Statistical Analysis Plan Addendum Document', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-12T11:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1315}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'completionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-08', 'studyFirstSubmitDate': '2015-10-22', 'resultsFirstSubmitDate': '2018-09-30', 'studyFirstSubmitQcDate': '2015-10-22', 'lastUpdatePostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-11-08', 'studyFirstPostDateStruct': {'date': '2015-10-26', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Alzheimer's Disease Assessment Scale - Cognitive Subscale 11 Items (ADAS-Cog-11) Score Change From Baseline to Week 24", 'timeFrame': 'Baseline, 24 weeks', 'description': 'The 11-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. The ADAS-Cog-11 total score range is from 0 to 70, with a higher score indicating more severe cognitive impairment.'}, {'measure': "Alzheimer's Disease Cooperative Study - Activities of Daily Living (ADCS-ADL) Score Change From Baseline to Week 24", 'timeFrame': 'Baseline, 24 weeks', 'description': 'The ADCS-ADL scale measures functional impairment in terms of activities of daily living. The score ranges from 0 to 78. The lower the score, the greater the impairment; higher scores indicate better (more desirable) function'}], 'secondaryOutcomes': [{'measure': 'Clinical Global Impression of Change - Plus Caregiver Interview (CIBIC+) Score at Week 24', 'timeFrame': '24 weeks', 'description': 'The CIBIC+ assessment measures the global functioning of the subject. The CIBIC+ is scored as a seven-point categorical rating, ranging from a score of 1 (indicating "very much improved"), to a score of 4 (indicating "no change"), or to a score of 7 (indicating "very much worse.") Lower CIBIC+ scores indicate better (more desirable) function'}, {'measure': 'The Dependence Scale (DS) Score Change From Baseline to Week 24', 'timeFrame': 'Baseline, 24 weeks', 'description': 'The DS measures the amount of assistance patients with dementia require in performing daily activities. The scale consists of 13 items, representing a range of severity from mild to severe levels of dependency. The score range is from 0 to 15 with higher scores indicating greater dependency.'}, {'measure': 'Neuropsychiatric Inventory (NPI) Score Change From Baseline to Week 24', 'timeFrame': 'Baseline and Week 24', 'description': 'The NPI is a behavior rating scale composed of a 12-item structured interview of the caregiver that is scored from 0 to 144 (the higher the score, the greater the psychiatric disturbance). It assesses 12 behavioral disturbances occurring in dementia patients: delusions, hallucinations, agitation, dysphoria, anxiety, apathy, irritability, euphoria, disinhibition, aberrant motor activity, night-time behavior disturbances, and eating disturbances. Both the frequency and the severity of each behavior are determined.'}, {'measure': 'ADAS-Cog-13 Score Change From Baseline to Week 24', 'timeFrame': 'Baseline, 24 weeks', 'description': '13-item ADAS-Cog assesses a range of cognitive abilities including memory, comprehension, orientation in time and place, and spontaneous speech. Most items are evaluated by tests, but some are dependent on clinician ratings on a 5-point scale. The ADAS-Cog-13 is the ADAS-Cog-11 with 2 additional items: delayed word recall and total digit cancellation. Scores for the ADAS-Cog-13 range from 0 to 85 with higher scores indicating greater dysfunction.'}, {'measure': 'Measurement of Concentrations of RVT-101 (Intepirdine) in Plasma', 'timeFrame': 'Week 6, Week 12, Week 18, Week 24', 'description': 'Measurement collected at timepoints Week 6, Week 12, Week 18, and Week 24'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ["Alzheimer's disease", 'RVT-101', 'donepezil', 'intepirdine', 'dementia'], 'conditions': ["Alzheimer's Disease"]}, 'descriptionModule': {'briefSummary': "This study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) as an adjunctive therapy to donepezil for the treatment of subjects with Alzheimer's disease.", 'detailedDescription': "This Phase 3 study seeks to confirm a demonstrated treatment effect of intepirdine (RVT-101) on both cognition and activities of daily living when added to stable donepezil treatment in subjects with mild-to-moderate Alzheimer's disease after 24 weeks of double-blind treatment. This study will also provide further information on the safety and tolerability of the 35-mg dose of intepirdine (RVT-101) when used in combination with donepezil compared to donepezil alone. This study is being conducted under the agreement of a Special Protocol Assessment by FDA. Subjects completing this study will be eligible to enroll in a 12 month open-label study of RVT-101 (RVT-101-3002) in which concomitant medications for the treatment of Alzheimer's disease including memantine will be allowed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Male or female subject with AD\n* Ongoing donepezil therapy for AD\n* An MMSE score 12 to 24 inclusive at Screening; MMSE score 10-26 inclusive at Baseline\n* Hachinski Ischaemia score less than or equal to 4 at Screening.\n* If female, subject must be: a. of non-childbearing potential or surgically sterile; or, b. willing to use an adequate methods of birth control. Male subjects who are sexually active will also be required to use an adequate form of birth control.\n* Subject has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator.\n* Subject has a reliable caregiver who is willing to report on subject's status throughout the study.\n\nExclusion Criteria:\n\nOther Causes for Dementia\n\n* Diagnosis of vascular dementia\n* Atypical clinical features or clinical course of dementia that would lead the investigator to conclude symptoms are more likely due to an alternate dementia diagnosis including, but not limited to, frontotemporal dementia, Lewy body dementia, or others.\n\nConfounding Medical Conditions\n\n* History of significant psychiatric illness such as schizophrenia or bipolar affective disorder or any other significant psychiatric illness that in the opinion of the investigator would interfere with participation in the study;\n* Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study."}, 'identificationModule': {'nctId': 'NCT02585934', 'briefTitle': "Study Evaluating Intepirdine (RVT-101) in Subjects With Mild to Moderate Alzheimer's Disease on Donepezil: MINDSET Study", 'organization': {'class': 'INDUSTRY', 'fullName': 'Sio Gene Therapies'}, 'officialTitle': "A Phase 3, Double-blind, Randomized Study of RVT-101 Versus Placebo When Added to Existing Stable Donepezil Treatment in Subjects With Mild to Moderate Alzheimer's Disease", 'orgStudyIdInfo': {'id': 'RVT-101-3001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RVT-101', 'description': 'RVT-101 adjunct to 5 mg or 10 mg donepezil', 'interventionNames': ['Drug: RVT-101']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo adjunct to 5 mg or 10 mg donepezil', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'RVT-101', 'type': 'DRUG', 'description': 'once daily, oral, 35 mg tablets', 'armGroupLabels': ['RVT-101']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'once daily, oral, pill manufactured to match RVT-101 35 mg tablet', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85005', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'US112', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'US220', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '91436', 'city': 'Encino', 'state': 'California', 'country': 'United States', 'facility': 'US168', 'geoPoint': {'lat': 34.15917, 'lon': -118.50119}}, {'zip': '92835', 'city': 'Fullerton', 'state': 'California', 'country': 'United States', 'facility': 'US117', 'geoPoint': {'lat': 33.87029, 'lon': -117.92534}}, {'zip': '90024', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 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