Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-03-05 @ 11:51 PM
Study NCT ID:
NCT02016560
Status:
COMPLETED
Last Update Posted:
2020-09-22
First Post:
2013-12-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects
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': 'C545186', 'term': 'florbetapir'}, {'id': 'C000591008', 'term': '7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaloperations@avidrp.com', 'phone': '215-298-0700', 'title': 'Medical Director', 'organization': 'Avid Radiopharmaceuticals, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. End of study for AE reporting was 48 hours after the last study drug administration. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug.', 'eventGroups': [{'id': 'EG000', 'title': 'Exploratory Younger Cognitively Healthy Subjects', 'description': 'Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 3, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Exploratory Older Cognitively Healthy Subjects', 'description': 'Male or female subjects ≥50 years of age with MMSE ≥29', 'otherNumAtRisk': 58, 'deathsNumAtRisk': 58, 'otherNumAffected': 17, 'seriousNumAtRisk': 58, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Exploratory MCI Subjects', 'description': "Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24", 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 21, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Exploratory AD Subjects', 'description': "Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE \\>10", 'otherNumAtRisk': 51, 'deathsNumAtRisk': 51, 'otherNumAffected': 13, 'seriousNumAtRisk': 51, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Confirmatory Subjects MCI', 'description': 'Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27', 'otherNumAtRisk': 98, 'deathsNumAtRisk': 98, 'otherNumAffected': 13, 'seriousNumAtRisk': 98, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'Confirmatory Subjects AD', 'description': 'Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27', 'otherNumAtRisk': 62, 'deathsNumAtRisk': 62, 'otherNumAffected': 0, 'seriousNumAtRisk': 62, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Ocular hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Flatulence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Frequent bowel movements', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Injection site pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 5}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 8}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 6}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Injection site extravasation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Application site irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Application site laceration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Feeling abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Therapeutic response unexpected', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood pressure increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Blood pressure systolic increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Platelet count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Heart rate increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Pain in extremity', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 4}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Paraesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Amnesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Disturbance in attention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Head discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypoaesthesia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Memory impairment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Urinary incontinence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Dermatitis contact', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Rash papular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Hot flush', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Supraventricular extrasystoles', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Cyanopsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Eye irritation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}, {'term': 'Panic attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'Erythema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'seriousEvents': [{'term': 'angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 16, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 58, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 98, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 51, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 98, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 62, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (20.0)'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '63', 'groupId': 'OG000'}, {'value': '68', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Predicted to Progress', 'description': 'Subjects with an Advanced AD Scan Pattern (τAD++). In either hemisphere, increased neocortical activity in the parietal/precuneus region(s), or frontal region(s) with increased uptake in the PLT, parietal, or occipital region(s).'}, {'id': 'OG001', 'title': 'Not Predicted to Progress', 'description': 'Subjects with a Moderate AD Scan Pattern (τAD+) or Not AD Scan Pattern (τAD-). Moderate scans were defined as in either hemisphere, increased neocortical activity limited to the posterolateral temporal (PLT) or occipital region(s). Not AD scans were defined as no increased neocortical activity, or increased neocortical activity isolated to the mesial temporal, anterolateral temporal, and/or frontal regions.'}], 'classes': [{'categories': [{'title': 'Clinically meaningful progression', 'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}, {'title': 'Did Not Progress', 'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '37', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.067', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Cox Proportional Hazard', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.581', 'ciLowerLimit': '0.968', 'ciUpperLimit': '2.581', 'pValueComment': 'A p-value of \\<0.05 was the a priori threshold for statistical significance.', 'groupDescription': 'The specific hypothesis tested was that the hazard of progressing to the clinically meaningful event (defined as CDR-SB value change of at least 1 within 18 months) will be significantly greater for subjects with flortaucipir scans rated by majority interpretation as predicted to progress (Advanced AD scan pattern), as compared to subjects with scans rated as not predicted to progress (Moderate or Not AD scan pattern).', 'statisticalMethod': 'Cox proportional hazards', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'The Cox proportional hazard model was adjusted for baseline age, American National Adult Reading Test (ANART) score, and baseline CDR-SB score.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'between baseline and 18 months', 'description': 'Confirm the relationship between neocortical flortaucipir uptake and the subsequent rate of cognitive decline at longitudinal follow up that was observed in the Exploratory Phase of the study. Patients were assigned to groups by majority classification of the flortaucipir positron emission tomography (PET) scan by five independent imaging physicians. Clinically meaningful cognitive and functional deterioration was defined as a 1 point or greater worsening on clinical dementia rating - sum of boxes (CDR-SB) score over the follow-up period.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Subjects from the confirmatory phase with valid flortaucipir visual read and 9 or 18 month clinical follow-up.'}, {'type': 'PRIMARY', 'title': 'Exploratory Phase: Cross-sectional Flortaucipir Imaging Results', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '97', 'groupId': 'OG001'}, {'value': '57', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Exploratory AD Subjects', 'description': "Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE \\>10"}, {'id': 'OG001', 'title': 'Exploratory MCI Subjects', 'description': "Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24"}, {'id': 'OG002', 'title': 'Exploratory Older Cognitively Healthy Subjects', 'description': 'Male or female subjects ≥50 years of age with MMSE ≥29'}, {'id': 'OG003', 'title': 'Exploratory Young Cognitively Healthy Subjects', 'description': 'Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29'}], 'classes': [{'title': 'Aβ+ SUVr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.53', 'spread': '0.037', 'groupId': 'OG000'}, {'value': '1.26', 'spread': '0.030', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.093', 'groupId': 'OG002'}]}]}, {'title': 'Aβ- SUVr', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '50', 'groupId': 'OG001'}, {'value': '52', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.03', 'spread': '0.051', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.029', 'groupId': 'OG001'}, {'value': '0.98', 'spread': '0.029', 'groupId': 'OG002'}, {'value': '1.01', 'spread': '0.039', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG002'], 'pValueComment': 'No adjustment for multiple comparisons. No a priori threshold was set.', 'groupDescription': 'ANCOVA model comparing the mean SUVr between AD and Older Cognitively Healthy within amyloid positive group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for age'}, {'pValue': '0.0622', 'groupIds': ['OG001', 'OG002'], 'pValueComment': 'No adjustment for multiple comparisons. No a priori threshold was set.', 'groupDescription': 'ANCOVA model comparing the mean SUVr between MCI and Older Cognitively Healthy within the amyloid positive group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for age'}, {'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'No adjustment for multiple comparisons. No a priori threshold was set.', 'groupDescription': 'ANCOVA model comparing the mean SUVr between AD and MCI within the amyloid positive group.', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Adjusted for age'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline scan', 'description': 'Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.', 'unitOfMeasure': 'standardized uptake value ratio (SUVr)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis included all subjects who received an injection of flortaucipir, had valid quantifiable flortaucipir imaging data available, and valid quantifiable florbetapir PET data.'}, {'type': 'PRIMARY', 'title': 'Exploratory Phase: Longitudinal Change in Tau Deposition Over Time, by Amyloid Status', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '90', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exploratory AB+ (Amyloid Beta Positive)', 'description': 'Exploratory MCI or AD subjects with a positive florbetapir PET scan for amyloid'}, {'id': 'OG001', 'title': 'Exploratory AB- (Amyloid Beta Negative)', 'description': 'Exploratory MCI or AD subjects with a negative florbetapir PET scan for amyloid'}], 'classes': [{'categories': [{'measurements': [{'value': '0.052359', 'spread': '0.008536', 'groupId': 'OG000'}, {'value': '0.000655', 'spread': '0.002394', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'groupDescription': 'SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid positive subjects only.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Test of whether the least squares mean change is significantly different than zero'}, {'pValue': '0.7851', 'groupIds': ['OG001'], 'groupDescription': 'SUVr change from baseline as dependent variable, baseline SUVr, age, and visit as independent variables, using an unstructured covariance structure for amyloid negative subjects only.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'EQUIVALENCE', 'nonInferiorityComment': 'Test of whether the least squares mean change is significantly different than zero'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'baseline and 18 months', 'description': 'Assess the rate of change of tau deposition as measured by flortaucipir uptake (SUVr) over time. Change = 18 months SUVr - baseline SUVr.', 'unitOfMeasure': 'standardized uptake value ratio (SUVr)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis of flortaucipir SUVr Change Over Time by Amyloid Status, Exploratory Phase Efficacy Population (AD and MCI subjects only)'}, {'type': 'SECONDARY', 'title': 'Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read', 'denoms': [{'units': 'Participants', 'counts': [{'value': '110', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Independent Readers', 'description': 'Scans were interpreted by 5 imaging physicians, blind to clinical data, after training by an Avid expert.'}], 'classes': [{'title': 'Reader 1 Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000', 'lowerLimit': '46.1', 'upperLimit': '71.8'}]}]}, {'title': 'Reader 1 Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '52.7', 'upperLimit': '76.4'}]}]}, {'title': 'Reader 2 Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '53.8', 'groupId': 'OG000', 'lowerLimit': '40.5', 'upperLimit': '66.7'}]}]}, {'title': 'Reader 2 Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '52.7', 'upperLimit': '76.4'}]}]}, {'title': 'Reader 3 Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.8', 'groupId': 'OG000', 'lowerLimit': '42.3', 'upperLimit': '68.4'}]}]}, {'title': 'Reader 3 Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '52.7', 'upperLimit': '76.4'}]}]}, {'title': 'Reader 4 Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '59.6', 'groupId': 'OG000', 'lowerLimit': '46.1', 'upperLimit': '71.8'}]}]}, {'title': 'Reader 4 Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '52.7', 'upperLimit': '76.4'}]}]}, {'title': 'Reader 5 Sensitivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '50.0', 'groupId': 'OG000', 'lowerLimit': '36.9', 'upperLimit': '63.1'}]}]}, {'title': 'Reader 5 Specificity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '58', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '65.5', 'groupId': 'OG000', 'lowerLimit': '52.7', 'upperLimit': '76.4'}]}]}], 'analyses': [{'groupIds': ['OG000'], 'nonInferiorityType': 'OTHER', 'otherAnalysisDescription': 'The hypothesis tested was that, of the 5 independent imaging physicians, at least 3 will have the lower bounds of 2-sided 95% confidence intervals ≥50%, for both sensitivity and specificity.'}], 'paramType': 'NUMBER', 'timeFrame': 'baseline and 18 months', 'description': 'This analysis used dichotomized CDR-SB change as a truth standard (1 point or more worsening = true positive vs. less than 1 point worsening = true negative) to assess the diagnostic performance of baseline Advanced AD tau status (τAD++) as determined by flortaucipir scan interpretation. Sensitivity and Specificity were calculated for each of the 5 independent imaging readers. Sensitivity is the percentage of true positive cases correctly identified by an Advanced AD pattern scan. Specificity is the percentage of true negative cases correctly identified by scans that were not classified as Advanced AD pattern.', 'unitOfMeasure': 'percentage of cases correctly identified', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All confirmatory phase subjects who completed 18 months of follow-up for the cognitive endpoint were read by each reader'}, {'type': 'SECONDARY', 'title': 'Exploratory Phase: Correlation Between Flortaucipir SUVr and Age', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '16', 'groupId': 'OG003'}, {'value': '11', 'groupId': 'OG004'}]}], 'groups': [{'id': 'OG000', 'title': 'Exploratory Young Cognitively Healthy Subjects', 'description': 'Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29'}, {'id': 'OG001', 'title': 'Exploratory Older Cognitively Healthy Subjects 50-59', 'description': 'Male or female subjects 50-59 years of age with MMSE ≥29'}, {'id': 'OG002', 'title': 'Exploratory Older Cognitively Healthy Subjects 60-69', 'description': 'Male or female subjects 60-69 years of age with MMSE ≥29'}, {'id': 'OG003', 'title': 'Exploratory Older Cognitively Healthy Subjects 70-79', 'description': 'Male or female subjects 70-79 years of age with MMSE ≥29'}, {'id': 'OG004', 'title': 'Exploratory Older Cognitively Healthy Subjects >=80', 'description': 'Male or female subjects 80 years of age or older with MMSE ≥29'}], 'classes': [{'categories': [{'measurements': [{'value': '1.0083', 'spread': '0.03905', 'groupId': 'OG000'}, {'value': '1.0203', 'spread': '0.03693', 'groupId': 'OG001'}, {'value': '1.0110', 'spread': '0.04149', 'groupId': 'OG002'}, {'value': '1.0010', 'spread': '0.02604', 'groupId': 'OG003'}, {'value': '1.0048', 'spread': '0.03978', 'groupId': 'OG004'}]}]}], 'analyses': [{'pValue': '0.4361', 'groupIds': ['OG000', 'OG001', 'OG002', 'OG003', 'OG004'], 'paramType': "Pearson's correlation coefficient", 'ciNumSides': 'TWO_SIDED', 'paramValue': '-0.0925', 'groupDescription': "Pearson's correlation coefficient", 'statisticalMethod': 'Pearson', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'baseline scan', 'description': 'Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.', 'unitOfMeasure': 'standardized uptake value ratio (SUVr)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Exploratory Young and Old healthy control subjects with a valid flortaucipir PET scan'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exploratory Young Cognitively Healthy Subjects', 'description': 'Male or female subjects ≥20 to ≤40 years of age with mini-mental status exam (MMSE) score ≥29'}, {'id': 'FG001', 'title': 'Exploratory Older Cognitively Healthy Subjects', 'description': 'Male or female subjects ≥50 years of age with MMSE Score ≥29'}, {'id': 'FG002', 'title': 'Exploratory MCI Subjects', 'description': "Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE Score ≥24"}, {'id': 'FG003', 'title': 'Exploratory AD Subjects', 'description': "Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE Score \\>10"}, {'id': 'FG004', 'title': 'Confirmatory Subjects MCI', 'description': 'Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27'}, {'id': 'FG005', 'title': 'Confirmatory Subjects AD', 'description': 'Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27'}], 'periods': [{'title': 'Exploratory Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '58'}, {'groupId': 'FG002', 'numSubjects': '98'}, {'groupId': 'FG003', 'numSubjects': '51'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '16'}, {'groupId': 'FG001', 'numSubjects': '54'}, {'groupId': 'FG002', 'numSubjects': '62'}, {'groupId': 'FG003', 'numSubjects': '35'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '4'}, {'groupId': 'FG002', 'numSubjects': '36'}, {'groupId': 'FG003', 'numSubjects': '16'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}, {'title': 'Confirmatory Phase', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '98'}, {'groupId': 'FG005', 'numSubjects': '62'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '76'}, {'groupId': 'FG005', 'numSubjects': '35'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '22'}, {'groupId': 'FG005', 'numSubjects': '27'}]}]}], 'recruitmentDetails': 'Exploratory cohort subjects were enrolled starting in Dec 2013. Confirmatory cohort subjects were enrolled Dec 2014-July 2017. Exploratory cohort subjects were not eligible for the confirmatory phase.', 'preAssignmentDetails': 'To ensure a distribution of disease severity in the confirmatory phase, a target was set to recruit at least one-third of the enrolled subjects with dementia'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Exploratory Young Cognitively Healthy Subjects', 'description': 'Male or female subjects ≥20 to ≤40 years of age with MMSE ≥29'}, {'id': 'BG001', 'title': 'Exploratory Older Cognitively Healthy Subjects', 'description': 'Male or female subjects ≥50 years of age with MMSE ≥29'}, {'id': 'BG002', 'title': 'Exploratory MCI Subjects', 'description': "Subjects with mild cognitive impairment consistent with National Institute of Aging (NIA)-Alzheimer's Association working group's diagnostic guidelines for AD (Albert et al. 2011) and MMSE ≥24"}, {'id': 'BG003', 'title': 'Exploratory AD Subjects', 'description': "Subjects with possible or probable AD dementia based on the NIA-Alzheimer's Association working group's diagnostic guidelines for AD (McKhann et al. 2011) and MMSE \\>10"}, {'id': 'BG004', 'title': 'Confirmatory Subjects MCI', 'description': 'Clinically diagnosed mild cognitive impairment with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27'}, {'id': 'BG005', 'title': 'Confirmatory Subjects AD', 'description': 'Clinically diagnosed dementia with a suspected neurodegenerative cause with an MMSE score ≥20 and ≤27'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '223', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '28.9', 'spread': '4.88', 'groupId': 'BG000'}, {'value': '68.5', 'spread': '10.29', 'groupId': 'BG001'}, {'value': '70.8', 'spread': '9.3', 'groupId': 'BG002'}, {'value': '73.9', 'spread': '9.01', 'groupId': 'BG003'}, {'value': '67.9', 'spread': '14.36', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Age, Continuous for Exploratory Cohort only'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, 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'BG003'}, {'value': '44', 'groupId': 'BG004'}, {'value': '30', 'groupId': 'BG005'}, {'value': '184', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '49', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}, {'value': '54', 'groupId': 'BG004'}, {'value': '32', 'groupId': 'BG005'}, {'value': '199', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': 'Exploratory Cohort - Sex: Female, Male', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '15', 'groupId': 'BG006'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '94', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '93', 'groupId': 'BG004'}, {'value': '58', 'groupId': 'BG005'}, {'value': '368', 'groupId': 'BG006'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Asian', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '5', 'groupId': 'BG006'}]}]}, {'title': 'Black or African American', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '24', 'groupId': 'BG006'}]}]}, {'title': 'White', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}, {'value': '47', 'groupId': 'BG003'}, {'value': '94', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}, {'value': '349', 'groupId': 'BG006'}]}]}, {'title': 'American Indian or Alaska Native', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}]}, {'title': 'Other', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'BG000'}, {'value': '58', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}, {'value': '51', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '62', 'groupId': 'BG005'}, {'value': '383', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '4', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Clinical Dementia Rating - Sum of Boxes (CDR-SB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '98', 'groupId': 'BG004'}, {'value': '61', 'groupId': 'BG005'}, {'value': '159', 'groupId': 'BG006'}]}], 'categories': [{'measurements': [{'value': '2.8', 'spread': '1.73', 'groupId': 'BG004'}, {'value': '4.3', 'spread': '1.69', 'groupId': 'BG005'}, {'value': '3.4', 'spread': '1.88', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'description': 'The CDR scale (Berg 1988) examines 6 cognitive functioning domains individually on a scale of 0 to 3. CDR Sum of Boxes is generated by summing the total score across domains. Scores range from 0 to 18, with higher scores indicating higher levels of cognitive impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Recorded at baseline only for confirmatory phase subjects'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2015-08-07', 'size': 618526, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-06-27T13:39', 'hasProtocol': True}, {'date': '2018-01-05', 'size': 3581305, 'label': 'Statistical Analysis Plan: Confirmatory Phase SAP', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-27T13:43', 'hasProtocol': False}, {'date': '2018-01-05', 'size': 555175, 'label': 'Statistical Analysis Plan: Confirmatory Phase Addendum SAP', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_002.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-27T13:44', 'hasProtocol': False}, {'date': '2017-11-27', 'size': 3452752, 'label': 'Statistical Analysis Plan: Exploratory Phase SAP', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_003.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-06-27T13:45', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Applies only to confirmatory phase: the independent readers are blinded to all clinical information.'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'All subjects in both the exploratory and confirmatory phases of the study, receive both florbetapir and florbetapir scans, regardless of subgroup assignment.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 383}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'dispFirstSubmitDate': '2018-07-20', 'completionDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2013-12-16', 'dispFirstSubmitQcDate': '2018-07-20', 'resultsFirstSubmitDate': '2020-06-27', 'studyFirstSubmitQcDate': '2013-12-16', 'dispFirstPostDateStruct': {'date': '2018-07-24', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2020-09-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-07', 'studyFirstPostDateStruct': {'date': '2013-12-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Confirmatory Phase: Relationship Between Neocortical Flortaucipir Uptake and the Subsequent Rate of Cognitive Decline', 'timeFrame': 'between baseline and 18 months', 'description': 'Confirm the relationship between neocortical flortaucipir uptake and the subsequent rate of cognitive decline at longitudinal follow up that was observed in the Exploratory Phase of the study. Patients were assigned to groups by majority classification of the flortaucipir positron emission tomography (PET) scan by five independent imaging physicians. Clinically meaningful cognitive and functional deterioration was defined as a 1 point or greater worsening on clinical dementia rating - sum of boxes (CDR-SB) score over the follow-up period.'}, {'measure': 'Exploratory Phase: Cross-sectional Flortaucipir Imaging Results', 'timeFrame': 'baseline scan', 'description': 'Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.'}, {'measure': 'Exploratory Phase: Longitudinal Change in Tau Deposition Over Time, by Amyloid Status', 'timeFrame': 'baseline and 18 months', 'description': 'Assess the rate of change of tau deposition as measured by flortaucipir uptake (SUVr) over time. Change = 18 months SUVr - baseline SUVr.'}], 'secondaryOutcomes': [{'measure': 'Confirmatory Phase: Diagnostic Performance of Flortaucipir Visual Read', 'timeFrame': 'baseline and 18 months', 'description': 'This analysis used dichotomized CDR-SB change as a truth standard (1 point or more worsening = true positive vs. less than 1 point worsening = true negative) to assess the diagnostic performance of baseline Advanced AD tau status (τAD++) as determined by flortaucipir scan interpretation. Sensitivity and Specificity were calculated for each of the 5 independent imaging readers. Sensitivity is the percentage of true positive cases correctly identified by an Advanced AD pattern scan. Specificity is the percentage of true negative cases correctly identified by scans that were not classified as Advanced AD pattern.'}, {'measure': 'Exploratory Phase: Correlation Between Flortaucipir SUVr and Age', 'timeFrame': 'baseline scan', 'description': 'Flortaucipir standardized uptake value ratio (SUVr). A value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '33587110', 'type': 'DERIVED', 'citation': 'Lu M, Pontecorvo MJ, Devous MD Sr, Arora AK, Galante N, McGeehan A, Devadanam C, Salloway SP, Doraiswamy PM, Curtis C, Truocchio SP, Flitter M, Locascio T, Devine M, Zimmer JA, Fleisher AS, Mintun MA; AVID Collaborators. Aggregated Tau Measured by Visual Interpretation of Flortaucipir Positron Emission Tomography and the Associated Risk of Clinical Progression of Mild Cognitive Impairment and Alzheimer Disease: Results From 2 Phase III Clinical Trials. JAMA Neurol. 2021 Apr 1;78(4):445-453. doi: 10.1001/jamaneurol.2020.5505.'}]}, 'descriptionModule': {'briefSummary': 'A Phase 2/3 cross-sectional and longitudinal observational study evaluating imaging characteristics of flortaucipir in control subjects and patients with clinically defined MCI and AD dementia (AD).', 'detailedDescription': 'This study was conducted in 2 phases: a Phase 2 Exploratory Phase and a Phase 3 Confirmatory Phase. An overarching goal of the Exploratory Phase of this protocol was to further investigate the pattern of flortaucipir PET imaging across the disease course, in cognitively healthy subjects through patients with cognitive decline. To accomplish this goal, the protocol investigated flortaucipir results in younger and older cognitively healthy normal volunteers and patients with clinical diagnoses for cognitive complaints, ranging from MCI to mild and moderate AD dementia. Additionally, the Exploratory Phase of this protocol investigated relationships between flortaucipir PET signal and cognitive decline over the 18-month study period.\n\nThe second, Confirmatory Phase of the study was designed to provide independent validation of the relationships observed in the exploratory analyses of the first phase. In particular, the goal of the second phase was to confirm the relationship between flortaucipir uptake in the brain as measured by PET signals at baseline and the subsequent rate of cognitive decline observed over the 18-month longitudinal follow up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nExploratory Cognitively Healthy Subjects\n\n* ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age\n* Mini-mental state examination (MMSE) ≥ 29\n* No significant history of cognitive impairment\n\nExploratory MCI Subjects\n\n* ≥ 50 years of age\n* MMSE ≥ 24\n* Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA) working group's diagnostic guidelines for AD\n* Have a study partner that can report on subject's activities of daily living\n\nExploratory AD Subjects\n\n* ≥ 50 years of age\n* MMSE \\> 10\n* Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines for AD\n* Have a study partner that can report on subject's activities of daily living\n\nConfirmatory Subjects\n\n* ≥ 50 years of age\n* MMSE ≥ 20 and ≤ 27\n* Cognitively impaired subjects with either MCI or dementia with a suspected neurodegenerative cause\n* Have a study partner that can report on subject's activities of daily living\n\nExclusion Criteria:\n\n* Current clinically significant psychiatric disease\n* Evidence of structural brain abnormalities\n* History of moderate or severe traumatic brain injury\n* Current clinically significant cardiovascular disease or ECG abnormalities, or additional risk factors for Torsades de Pointes\n* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer\n* History of alcohol or substance abuse or dependence\n* Females of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception\n* Have received or participated in a trial with investigational medications in the past 30 days\n* Have had a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session."}, 'identificationModule': {'nctId': 'NCT02016560', 'acronym': 'MCI', 'briefTitle': 'Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI, and AD Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': "An Open Label, Multicenter Study, Evaluating the Safety and Imaging Characteristics of 18F-AV-1451 in Cognitively Healthy Volunteers, Subjects With Mild Cognitive Impairment, and Subjects With Alzheimer's Disease", 'orgStudyIdInfo': {'id': '18F-AV-1451-A05'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Exploratory Cognitively Healthy Subjects', 'description': 'Subjects will receive an IV injection, 370 megabecquerel (MBq) (10 millicurie \\[mCi\\]), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline.', 'interventionNames': ['Drug: florbetapir F 18', 'Drug: Flortaucipir F18', 'Procedure: Brain PET Scan']}, {'type': 'EXPERIMENTAL', 'label': 'Exploratory MCI Subjects', 'description': 'Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months.', 'interventionNames': ['Drug: florbetapir F 18', 'Drug: Flortaucipir F18', 'Procedure: Brain PET Scan']}, {'type': 'EXPERIMENTAL', 'label': 'Exploratory AD Subjects', 'description': 'Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 at baseline. Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of flortaucipir at baseline, 9 months and 18 months.', 'interventionNames': ['Drug: florbetapir F 18', 'Drug: Flortaucipir F18', 'Procedure: Brain PET Scan']}, {'type': 'EXPERIMENTAL', 'label': 'Confirmatory Subjects', 'description': 'Subjects will receive an IV injection, 370 MBq (10 mCi), single dose of florbetapir F 18 and flortaucipir at baseline.', 'interventionNames': ['Drug: florbetapir F 18', 'Drug: Flortaucipir F18', 'Procedure: Brain PET Scan']}], 'interventions': [{'name': 'florbetapir F 18', 'type': 'DRUG', 'otherNames': ['Amyvid', '18F-AV-45'], 'armGroupLabels': ['Confirmatory Subjects', 'Exploratory AD Subjects', 'Exploratory Cognitively Healthy Subjects', 'Exploratory MCI Subjects']}, {'name': 'Flortaucipir F18', 'type': 'DRUG', 'otherNames': ['T807', '18F-AV-1451'], 'armGroupLabels': ['Confirmatory Subjects', 'Exploratory AD Subjects', 'Exploratory Cognitively Healthy Subjects', 'Exploratory MCI Subjects']}, {'name': 'Brain PET Scan', 'type': 'PROCEDURE', 'description': 'positron emission tomography (PET) scan of the brain', 'armGroupLabels': ['Confirmatory Subjects', 'Exploratory AD Subjects', 'Exploratory Cognitively Healthy Subjects', 'Exploratory MCI Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Banner Alzheimer's Institute", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85258', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Four Peaks Neurology', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85259', 'city': 'Scottsdale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Mayo Clinic', 'geoPoint': {'lat': 33.50921, 'lon': -111.89903}}, {'zip': '85351', 'city': 'Sun City', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner Sun Health Research Institute', 'geoPoint': {'lat': 33.59754, 'lon': -112.27182}}, {'zip': '92697', 'city': 'Irvine', 'state': 'California', 'country': 'United States', 'facility': 'UC Irvine', 'geoPoint': {'lat': 33.66946, 'lon': -117.82311}}, {'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}, {'zip': '95816', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Norther California PET Imaging Center', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '95817', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'UC Davis', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UC San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 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