Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2026-01-03 @ 11:31 PM
Study NCT ID:
NCT02167594
Status:
COMPLETED
Last Update Posted:
2020-08-28
First Post:
2014-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013494', 'term': 'Supranuclear Palsy, Progressive'}, {'id': 'D000088282', 'term': 'Corticobasal Degeneration'}], 'ancestors': [{'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D009886', 'term': 'Ophthalmoplegia'}, {'id': 'D015835', 'term': 'Ocular Motility Disorders'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'End of study for AE reporting was 48 hours after flortaucipir administration at each imaging visit.', 'description': 'Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection, at an imaging visit. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to flortaucipir.', 'eventGroups': [{'id': 'EG000', 'title': 'PSP Subjects', 'description': 'Amyloid negative subjects with Progressive Supranuclear Palsy (PSP) receiving a flortaucipir PET scan', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 2, 'seriousNumAtRisk': 20, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'CBD Subjects', 'description': 'Amyloid negative subjects with Corticobasal Degeneration (CBD) receiving a flortaucipir PET scan', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 1, 'seriousNumAtRisk': 6, 'deathsNumAffected': 1, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers receiving a flortaucipir PET scan', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'bronchial secretion retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'muscle spasms', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}, {'term': 'asthenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (17.0)'}], 'frequencyThreshold': '1.0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Flortaucipir Imaging in PSP, CBD and Healthy Volunteers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'PSP Subjects', 'description': 'Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.\n\nFlortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)'}, {'id': 'OG001', 'title': 'CBD Subjects', 'description': 'Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.\n\nFlortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)'}, {'id': 'OG002', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers receiving a flortaucipir PET scan at baseline.\n\nFlortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)'}, {'id': 'OG003', 'title': 'All Subjects', 'description': 'All subjects combined'}], 'classes': [{'title': 'Right Dentate Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '1.12', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '1.03', 'spread': '0.12', 'groupId': 'OG002'}, {'value': '1.15', 'spread': '0.12', 'groupId': 'OG003'}]}]}, {'title': 'Right Dentate 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.17', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.11', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '1.15', 'spread': '0.10', 'groupId': 'OG003'}]}]}, {'title': 'Left Dentate Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.16', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '1.09', 'spread': '0.04', 'groupId': 'OG001'}, {'value': '1.08', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '1.14', 'spread': '0.09', 'groupId': 'OG003'}]}]}, {'title': 'Left Dentate 9 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.13', 'spread': '0.11', 'groupId': 'OG000'}, {'value': '1.08', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '1.12', 'spread': '0.10', 'groupId': 'OG003'}]}]}, {'title': 'Right Globus Pallidus Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.60', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.40', 'spread': '0.20', 'groupId': 'OG001'}, {'value': '1.29', 'spread': '0.06', 'groupId': 'OG002'}, {'value': '1.53', 'spread': '0.19', 'groupId': 'OG003'}]}]}, {'title': 'Right Globus Pallidus 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.58', 'spread': '0.13', 'groupId': 'OG000'}, {'value': '1.47', 'spread': '0.19', 'groupId': 'OG001'}, {'value': '1.55', 'spread': '0.15', 'groupId': 'OG003'}]}]}, {'title': 'Left Globus Pallidus Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.62', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.56', 'spread': '0.32', 'groupId': 'OG001'}, {'value': '1.30', 'spread': '0.07', 'groupId': 'OG002'}, {'value': '1.58', 'spread': '0.21', 'groupId': 'OG003'}]}]}, {'title': 'Left Globus Pallidus 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.62', 'spread': '0.15', 'groupId': 'OG000'}, {'value': '1.62', 'spread': '0.40', 'groupId': 'OG001'}, {'value': '1.62', 'spread': '0.21', 'groupId': 'OG003'}]}]}, {'title': 'Global PSP/CBD Summary Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.38', 'spread': '0.10', 'groupId': 'OG000'}, {'value': '1.29', 'spread': '0.11', 'groupId': 'OG001'}, {'value': '1.17', 'spread': '0.03', 'groupId': 'OG002'}, {'value': '1.34', 'spread': '0.12', 'groupId': 'OG003'}]}]}, {'title': 'Global PSP/CBD Summary 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '1.37', 'spread': '0.09', 'groupId': 'OG000'}, {'value': '1.32', 'spread': '0.13', 'groupId': 'OG001'}, {'value': '1.36', 'spread': '0.10', 'groupId': 'OG003'}]}]}, {'title': 'AD Cortical Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '0.99', 'spread': '0.06', 'groupId': 'OG001'}, {'value': '1.02', 'spread': '0.02', 'groupId': 'OG002'}, {'value': '0.99', 'spread': '0.04', 'groupId': 'OG003'}]}]}, {'title': 'AD Cortical 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '23', 'groupId': 'OG003'}]}], 'categories': [{'measurements': [{'value': '0.99', 'spread': '0.03', 'groupId': 'OG000'}, {'value': '1.00', 'spread': '0.05', 'groupId': 'OG001'}, {'value': '0.99', 'spread': '0.04', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline and 9 month scans', 'description': "A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For 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': 'Healthy volunteers did not receive 9 month follow-up scans. 9 month data presented only for those subjects who completed both a baseline and 9 month scan.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'PSP Subjects', 'description': 'Amyloid negative subjects with Progressive Supranuclear Palsy (PSP) receiving a flortaucipir PET scan'}, {'id': 'FG001', 'title': 'CBD Subjects', 'description': 'Amyloid negative subjects with Corticobasal Degeneration (CBD) receiving a flortaucipir PET scan'}, {'id': 'FG002', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers receiving a flortaucipir PET scan'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'comment': 'Completed = 9 month flortaucipir PET scan acquired', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Subjects recruited between Aug 2014 and Jul 2016.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'PSP Subjects', 'description': 'Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.\n\nFlortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)'}, {'id': 'BG001', 'title': 'CBD Subjects', 'description': 'Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.\n\nFlortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)'}, {'id': 'BG002', 'title': 'Healthy Volunteers', 'description': 'Healthy volunteers receiving a flortaucipir PET scan at baseline.\n\nFlortaucipir F18 PET scan: IV injection, 370 MBq (10 mCi)'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '69.2', 'spread': '5.88', 'groupId': 'BG000'}, {'value': '72.2', 'spread': '7.41', 'groupId': 'BG001'}, {'value': '68.7', 'spread': '10.41', 'groupId': 'BG002'}, {'value': '69.8', 'spread': '6.53', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '19', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '29', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Mini Mental Status Exam (MMSE)', 'classes': [{'categories': [{'measurements': [{'value': '26.5', 'spread': '3.12', 'groupId': 'BG000'}, {'value': '26.3', 'spread': '4.32', 'groupId': 'BG001'}, {'value': '29.3', 'spread': '0.58', 'groupId': 'BG002'}, {'value': '26.7', 'spread': '3.28', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'description': 'Mini-mental status exam (MMSE) is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 29}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-21', 'studyFirstSubmitDate': '2014-06-17', 'resultsFirstSubmitDate': '2020-07-16', 'studyFirstSubmitQcDate': '2014-06-18', 'lastUpdatePostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-08-21', 'studyFirstPostDateStruct': {'date': '2014-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-08-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-07-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Flortaucipir Imaging in PSP, CBD and Healthy Volunteers', 'timeFrame': 'baseline and 9 month scans', 'description': "A PSP/CBD (PSP = progressive supranuclear palsy; CBD = corticobasal degeneration) targeted composite Standardized Uptake Value ratio (SUVr) was calculated as the voxel-weighted average from the regional SUVr values of the left, right, and total globus pallidus and the dentate nuclei of the cerebellum for both the baseline and 9 month PET scans. Additionally, a global cortical Alzheimer's Disease (AD)-targeted cortical SUVr was calculated. For 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': ['Progressive Supranuclear Palsy', 'Corticobasal Degeneration']}, 'descriptionModule': {'briefSummary': 'This study will evaluate flortaucipir for brain imaging of tau in subjects with progressive supranuclear palsy (PSP), corticobasal degeneration (CBD) and healthy volunteers.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\nCognitively Healthy Volunteers\n\n* Mini-mental state examination (MMSE) ≥ 28\n* No history of cognitive decline or parkinsonian motor disorder\n\nCBD and PSP subjects\n\n* Able to walk 10 steps with minimal assistance\n* MMSE ≥ 14 and ≤ 30\n* Subject has a reliable study partner who agrees to accompany subject to visits and spends at least 5 hours per week with the subject\n\nPSP subjects only\n\n* Meet National Institute of Neurological Disorders and Stroke - Society for Progressive Supranuclear Palsy (NINDS-SPSP) probable or possible PSP criteria as modified for the Neuroprotection and Natural History Parkinson Plus Syndromes (NNIPPS) clinical trial\n\nCBD subjects only\n\n* Meets 2013 consensus criteria for possible or probable corticobasal degeneration, corticobasal syndrome (CBS) subtype\n\nExclusion Criteria:\n\nAll subjects\n\n* Have evidence of structural abnormalities such as vascular disease, large strokes or severe white matter disease or other mass lesion on screening MRI\n* Claustrophobia\n* Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (e.g. corrected QT interval \\>450 msec)\n* Have a history of risk factors for Torsades de Pointes (e.g. heart failure, hypokalemia, family history of long QT syndrome)\n* Have a current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer\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\n* Have a history of neuroleptic use for a prolonged period of time or within the past 6 months\n\nPSP and CBD subjects\n\n* Have evidence of amyloid deposition\n* Meet National Institute on Aging-Alzheimer's Association criteria for probable Alzheimer's Disease\n* Have any other neurological condition other than CBS or PSP that could account for cognitive or motor deficits\n* Serum or plasma progranulin level less than one standard deviation below the normal subject mean for the laboratory performing the assay\n* Have a high-risk family history suggestive of tar DNA binding protein (TDP)-43 pathology or known mutations"}, 'identificationModule': {'nctId': 'NCT02167594', 'briefTitle': 'Tau Imaging in Subjects With Progressive Supranuclear Palsy, Corticobasal Degeneration and Healthy Volunteers', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': '18F-AV-1451 Injection for Brain Imaging of Tau in Subjects With Progressive Supranuclear Palsy (PSP), Subjects With Corticobasal Degeneration (CBD) and Healthy Volunteers', 'orgStudyIdInfo': {'id': '18F-AV-1451-A09'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PSP Subjects', 'description': 'Amyloid negative subjects with PSP receiving a flortaucipir PET scan at baseline and at 9 months.', 'interventionNames': ['Drug: Flortaucipir F18', 'Procedure: Brain PET scan']}, {'type': 'EXPERIMENTAL', 'label': 'CBD subjects', 'description': 'Amyloid negative subjects with CBD receiving a flortaucipir PET scan at baseline and at 9 months.', 'interventionNames': ['Drug: Flortaucipir F18', 'Procedure: Brain PET scan']}, {'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'description': 'Healthy volunteers receiving a flortaucipir PET scan at baseline.', 'interventionNames': ['Drug: Flortaucipir F18', 'Procedure: Brain PET scan']}], 'interventions': [{'name': 'Flortaucipir F18', 'type': 'DRUG', 'otherNames': ['[F18]T807', '18F-AV-1451', 'LY3191748', 'Tauvid'], 'description': 'IV injection, 370 megabecquerel (MBq) (10 mCi)', 'armGroupLabels': ['CBD subjects', 'Healthy volunteers', 'PSP Subjects']}, {'name': 'Brain PET scan', 'type': 'PROCEDURE', 'description': 'positron emission tomography (PET) scan of the brain 75-105 minutes post-injection', 'armGroupLabels': ['CBD subjects', 'Healthy volunteers', 'PSP Subjects']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'UCSD Movement Disorder Clinic', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '94158', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'UCSF Neurosciences Clinical Research Unit', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '06510', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Molecular Neuroimaging', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Perelman School of Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avid Radiopharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avid Radiopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}