Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT04474405
Status:
COMPLETED
Last Update Posted:
2020-09-25
First Post:
2020-07-08
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired 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': 'C000591008', 'term': '7-(6-fluoropyridin-3-yl)-5H-pyrido(4,3-b)indole'}, {'id': 'C545186', 'term': 'florbetapir'}]}}, '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 the last study drug administration.', 'description': 'Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection of florbetapir or flortaucipir. AEs occurring after study drug administration, but outside that window were not recorded in the database, unless considered attributable to study drug injection. MRI/Amyloid extension cohort n=4 represents only those subjects receiving florbetapir PET scans.', 'eventGroups': [{'id': 'EG000', 'title': 'Brain PET Scan (AD Subjects)', 'description': 'AD subjects receiving a flortaucipir and florbetapir PET scan', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Brain PET (MCI Subjects)', 'description': 'Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 0, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Brain PET (YCN Subjects)', 'description': 'Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 1, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Brain PET (OCN Subjects)', 'description': 'Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG004', 'title': 'Whole Body PET Scan', 'description': 'Subjects receiving a whole body PET scan after flortaucipir administration', 'otherNumAtRisk': 9, 'deathsNumAtRisk': 9, 'otherNumAffected': 3, 'seriousNumAtRisk': 9, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG005', 'title': 'MRI and Amyloid Extension Cohort', 'description': 'Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000', 'otherNumAtRisk': 4, 'deathsNumAtRisk': 4, 'otherNumAffected': 0, 'seriousNumAtRisk': 4, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'diarrhoea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}, {'term': 'musculoskeletal discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 9, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 4, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (16.1)'}], 'frequencyThreshold': '0.5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Brain Flortaucipir Uptake', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}, {'value': '5', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Brain PET Scan (AD Subjects)', 'description': 'AD subjects receiving a flortaucipir and florbetapir PET scan'}, {'id': 'OG001', 'title': 'Brain PET (MCI Subjects)', 'description': 'Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan'}, {'id': 'OG002', 'title': 'Brain PET (YCN Subjects)', 'description': 'Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan'}, {'id': 'OG003', 'title': 'Brain PET (OCN Subjects)', 'description': 'Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan'}], 'classes': [{'categories': [{'measurements': [{'value': '1.780', 'spread': '0.857', 'groupId': 'OG000'}, {'value': '1.317', 'spread': '0.161', 'groupId': 'OG001'}, {'value': '1.128', 'spread': '0.047', 'groupId': 'OG002'}, {'value': '1.107', 'spread': '0.175', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '80-100 minutes postdose', 'description': 'Brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVr), normalized to the entire cerebellum. A global cortical average volume of interest (VOI) is the average SUVr of the occipital cortex, parietal cortex, and temporal cortex. 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': 'Includes quantitative flortaucipir PET scan results from subjects with a flortaucipir scan in the present study (n=15), plus subjects consented in the MRI/Amyloid extension cohort who provided valid flortaucipir PET scans (n=3 AD, n=2 MCI, n=1 OCN) and received MRI in the present study permitting quantitative analysis per protocol.'}, {'type': 'PRIMARY', 'title': 'Flortaucipir Whole Body Effective Dose', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Body Flortaucipir PET Scan', 'description': 'Subjects receiving a whole body PET scan after flortaucipir administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0241', 'spread': '0.00160', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'injection to 6 hours postdose', 'description': 'Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) radiation dosimetry code. Results calculated using 73.7-kg man model.', 'unitOfMeasure': 'mSv/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only subjects from the whole body PET scan group (n=9)'}, {'type': 'SECONDARY', 'title': 'Flortaucipir PET Correlations With Cognitive Assessments (Mini-mental State Exam)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects/Brain PET', 'description': 'Includes all AD, MCI, YCN, and OCN subjects enrolled in the study with flortaucipir Brain PET scans'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.404', 'groupId': 'OG000', 'lowerLimit': '-0.706', 'upperLimit': '0.044'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at baseline', 'description': "Spearman's correlations between flortaucipir SUVr and cognitive function as measured on the Mini-Mental State Examination (MMSE). MMSE is a 30-point questionnaire that is used to measure cognitive impairment. 0 is the lowest score and 30 is the highest score, indicating normal cognitive function. Lower MMSE scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes quantitative flortaucipir brain PET scan results from subjects with a flortaucipir scan in the present study (n=15), plus subjects consented in the MRI/Amyloid extension cohort who provided valid flortaucipir PET scans from a previous study (n=6) and received MRI in the present study permitting quantitation per protocol.'}, {'type': 'SECONDARY', 'title': 'Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Digit Symbol Substitution Test)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects/Brain PET', 'description': 'Includes all AD, MCI, YCN, and OCN subjects enrolled in the study with flortaucipir Brain PET scans'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.273', 'groupId': 'OG000', 'lowerLimit': '-0.744', 'upperLimit': '0.403'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at baseline', 'description': "Spearman's correlations between flortaucipir SUVr and cognitive function as measured on Digit Symbol Substitution Test (DSST). The DSST is sensitive to the presence of cognitive dysfunction as well as to change in cognitive function. Scores range from 0 to 133. Lower DSST scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes quantitative flortaucipir PET scan results from subjects with a flortaucipir scan in the present study (n=15), plus subjects consented in the MRI/Amyloid extension cohort who provided valid flortaucipir PET scans from a previous study n=6) and received MRI in the present study permitting quantitation per protocol.'}, {'type': 'SECONDARY', 'title': "Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Alzheimer's Disease Assessment Scale)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '21', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'All Subjects/Brain PET', 'description': 'Includes all AD, MCI, YCN, and OCN subjects enrolled in the study with flortaucipir Brain PET scans'}], 'classes': [{'categories': [{'measurements': [{'value': '0.220', 'groupId': 'OG000', 'lowerLimit': '-0.447', 'upperLimit': '0.719'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'at baseline', 'description': "Spearman's correlations between flortaucipir SUVr and cognitive function as measured on a Modified Alzheimer's Disease Assessment Scale (ADAS)-Cognitive subscale (including orientation, verbal memory, language, and praxis, minus the spoken language assessment). Scores on the modified scale can range from 0 to 65. Higher scores indicate worsening cognitive function. For this analysis, positive correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and negative correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation.", 'unitOfMeasure': 'correlation coefficient', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes quantitative flortaucipir PET scan results from subjects with a flortaucipir scan in the present study (n=15), plus subjects consented in the MRI/Amyloid extension cohort who provided valid flortaucipir PET scans from a previous study (n=6) and received MRI in the present study permitting quantitation per protocol.'}, {'type': 'POST_HOC', 'title': 'Flortaucipir Whole Body Effective Dose With Urine Radioactivity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Whole Body Flortaucipir PET Scan', 'description': 'Subjects receiving a whole body PET scan after flortaucipir administration'}], 'classes': [{'categories': [{'measurements': [{'value': '0.0235', 'spread': '0.0016', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'injection to 6 hours postdose', 'description': 'Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) radiation dosimetry code. Results calculated using 73.7-kg man model and accounting for total integrated radioactivity excreted in the urine collected in Study A15 (NCT02336360)', 'unitOfMeasure': 'mSv/MBq', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Includes only subjects from the whole body PET scan group (n=9)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Brain PET Scan (AD Subjects)', 'description': "Alzheimer's disease (AD) subjects receiving a flortaucipir and florbetapir PET scan"}, {'id': 'FG001', 'title': 'Brain PET (MCI Subjects)', 'description': 'Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan'}, {'id': 'FG002', 'title': 'Brain PET (YCN Subjects)', 'description': 'Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan'}, {'id': 'FG003', 'title': 'Brain PET (OCN Subjects)', 'description': 'Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan'}, {'id': 'FG004', 'title': 'Whole Body PET Scan', 'description': 'Subjects receiving a whole body PET scan after flortaucipir administration'}, {'id': 'FG005', 'title': 'MRI and Amyloid Extension Cohort', 'description': 'Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000. \\[n=3 AD, n=2 MCI, n=1 OCN\\]'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '5'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '13'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'Flortaucipir PET Scan', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Florbetapir PET Scan', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '0'}, {'groupId': 'FG005', 'numSubjects': '4'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '4'}, {'groupId': 'FG003', 'numSubjects': '4'}, {'groupId': 'FG004', 'numSubjects': '9'}, {'groupId': 'FG005', 'numSubjects': '7'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '4'}, {'groupId': 'FG005', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '1'}, {'groupId': 'FG005', 'numSubjects': '0'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}, {'groupId': 'FG004', 'numSubjects': '3'}, {'groupId': 'FG005', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Enrollment occurred between Aug and Dec 2013. Subjects in the MRI and Amyloid Extension cohort received flortaucipir brain PET scans in Study T807000 (NCT01733355)', 'preAssignmentDetails': 'Subjects enrolled in the MRI/amyloid extension cohort were to be combined with the Brain PET subgroups for analysis per protocol. MRI allows previously-obtained flortaucipir scan and cognitive data to be combined with the PET scan results from the Brain PET subgroups for analysis.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}], 'groups': [{'id': 'BG000', 'title': 'Brain PET Scan (AD Subjects)', 'description': 'AD subjects receiving a flortaucipir and florbetapir PET scan'}, {'id': 'BG001', 'title': 'Brain PET (MCI Subjects)', 'description': 'Mild cognitive impairment (MCI) subjects receiving a florbetapir and a flortaucipir PET scan'}, {'id': 'BG002', 'title': 'Brain PET (YCN Subjects)', 'description': 'Young cognitively normal (YCN) subjects receiving florbetapir and a flortaucipir PET scan'}, {'id': 'BG003', 'title': 'Brain PET (OCN Subjects)', 'description': 'Older cognitively normal (OCN) subjects receiving a florbetapir and a flortaucipir PET scan'}, {'id': 'BG004', 'title': 'Whole Body PET Scan', 'description': 'Subjects receiving a whole body PET scan after flortaucipir administration'}, {'id': 'BG005', 'title': 'MRI and Amyloid Extension Cohort', 'description': 'Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000. \\[n=3 AD, n=2 MCI, n=1 OCN\\]'}, {'id': 'BG006', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '68.0', 'spread': '7.87', 'groupId': 'BG000'}, {'value': '78.7', 'spread': '2.89', 'groupId': 'BG001'}, {'value': '27.5', 'spread': '2.08', 'groupId': 'BG002'}, {'value': '66.3', 'spread': '0.50', 'groupId': 'BG003'}, {'value': '56.3', 'spread': '4.42', 'groupId': 'BG004'}, {'value': '73.0', 'spread': '13.09', 'groupId': 'BG005'}, {'value': '60.1', 'spread': '16.52', 'groupId': 'BG006'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '11', 'groupId': 'BG006'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '16', 'groupId': 'BG006'}]}, {'title': 'Unknown', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '8', 'groupId': 'BG006'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}, {'title': 'White', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '18', 'groupId': 'BG006'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', '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': '1', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}, {'value': '4', 'groupId': 'BG005'}, {'value': '28', 'groupId': 'BG006'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Baseline demographics analysis includes subjects receiving a florbetapir or a flortaucipir PET scan in the study.'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2013-12-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-03', 'studyFirstSubmitDate': '2020-07-08', 'resultsFirstSubmitDate': '2020-07-27', 'studyFirstSubmitQcDate': '2020-07-15', 'lastUpdatePostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-03', 'studyFirstPostDateStruct': {'date': '2020-07-16', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2013-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Brain Flortaucipir Uptake', 'timeFrame': '80-100 minutes postdose', 'description': 'Brain imaging of tau in healthy volunteers and subjects with cognitive impairment. Standard uptake value ratios (SUVr), normalized to the entire cerebellum. A global cortical average volume of interest (VOI) is the average SUVr of the occipital cortex, parietal cortex, and temporal cortex. For SUVr, a value of 1 signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.'}, {'measure': 'Flortaucipir Whole Body Effective Dose', 'timeFrame': 'injection to 6 hours postdose', 'description': 'Radiation dose estimates measured in millisieverts per megabecquerel (mSv/MBq) for the whole body obtained from Organ Level Internal Dose Assessment/Exponential Modeling (OLINDA/EXM) radiation dosimetry code. Results calculated using 73.7-kg man model.'}], 'secondaryOutcomes': [{'measure': 'Flortaucipir PET Correlations With Cognitive Assessments (Mini-mental State Exam)', 'timeFrame': 'at baseline', 'description': "Spearman's correlations between flortaucipir SUVr and cognitive function as measured on the Mini-Mental State Examination (MMSE). MMSE is a 30-point questionnaire that is used to measure cognitive impairment. 0 is the lowest score and 30 is the highest score, indicating normal cognitive function. Lower MMSE scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation."}, {'measure': 'Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Digit Symbol Substitution Test)', 'timeFrame': 'at baseline', 'description': "Spearman's correlations between flortaucipir SUVr and cognitive function as measured on Digit Symbol Substitution Test (DSST). The DSST is sensitive to the presence of cognitive dysfunction as well as to change in cognitive function. Scores range from 0 to 133. Lower DSST scores indicate worsening cognitive function. For this analysis, negative correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and positive correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation."}, {'measure': "Flortaucipir PET Correlations With Cognitive Assessments Cognitive Assessments (Alzheimer's Disease Assessment Scale)", 'timeFrame': 'at baseline', 'description': "Spearman's correlations between flortaucipir SUVr and cognitive function as measured on a Modified Alzheimer's Disease Assessment Scale (ADAS)-Cognitive subscale (including orientation, verbal memory, language, and praxis, minus the spoken language assessment). Scores on the modified scale can range from 0 to 65. Higher scores indicate worsening cognitive function. For this analysis, positive correlation values indicate that higher flortaucipir uptake is associated with decreasing cognitive function and negative correlation values indicate that lower flortaucipir uptake is associated with better cognitive function. 95% confidence interval uses a Fisher's z transformation."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'This early phase 1 study explored the brain uptake, retention, and safety of flortaucipir and obtained preliminary information regarding dosimetry of flortaucipir.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy volunteers had an Mini-Mental State Examination (MMSE) score of ≥ 29;\n* MCI due to Alzheimer's disease (AD) consistent with National Institute on Aging (NIA)-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:270-9, 2011)\n* Possible or probable AD: Met clinical criteria for possible or probable AD based on the NIA-Alzheimer's Association working group's on diagnostic guidelines for AD (Alzheimer's Dementia 7:263-9, 2011)\n\nExclusion Criteria:\n\n* Current clinically significant psychiatric disease.\n* Evidence of structural abnormalities such as major stroke or mass on MRI that would have made a diagnosis of impairment due to AD unlikely or was likely to interfere with interpretation of a PET scan on MRI.\n* Claustrophobic or otherwise unable to tolerate the imaging procedure.\n* Current clinically significant cardiovascular disease or clinically significant abnormalities on screening electrocardiogram (including, but not limited to, corrected QT interval \\>450 msec).\n* Current clinically significant infectious disease, endocrine or metabolic disease, pulmonary, renal or hepatic impairment, or cancer\n* History of alcohol abuse or substance abuse or dependence\n* Female subjects of childbearing potential who were not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.\n* Required medications with a narrow therapeutic window\n* Received a non-study related radiopharmaceutical imaging or treatment procedure within 7 days prior to imaging session\n* Receiving any investigational medications or had participated in a trial with investigational medications within the last 30 days"}, 'identificationModule': {'nctId': 'NCT04474405', 'briefTitle': 'Exploratory Evaluation of Flortaucipir Injection in Healthy Volunteers and Cognitively Impaired Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': 'An Exploratory Evaluation of the Tau Protein Binding Properties, Whole-Body Biodistribution and Safety of 18F-AV-1451 Injection in Healthy Volunteers and Cognitively Impaired Subjects', 'orgStudyIdInfo': {'id': '18F-AV-1451-A01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brain flortaucipir PET scan', 'description': 'Subjects receiving a brain PET scan after flortaucipir administration', 'interventionNames': ['Drug: Flortaucipir F18', 'Procedure: Brain PET Scan', 'Drug: Florbetapir F 18', 'Procedure: Brain MRI']}, {'type': 'EXPERIMENTAL', 'label': 'Whole body flortaucipir PET scan', 'description': 'Subjects receiving a whole body PET scan after flortaucipir administration', 'interventionNames': ['Drug: Flortaucipir F18', 'Procedure: Whole body PET scan']}, {'type': 'OTHER', 'label': 'MRI and Amyloid Extension Cohort', 'description': 'Magnetic resonance imaging (MRI) scans and amyloid scans for subjects previously participating in Study T807000 (NCT01733355)', 'interventionNames': ['Procedure: Brain PET Scan', 'Drug: Florbetapir F 18', 'Procedure: Brain MRI']}], 'interventions': [{'name': 'Flortaucipir F18', 'type': 'DRUG', 'otherNames': ['18F-AV-1451', '[F-18]T807', 'LY3191748', 'Tauvid'], 'description': 'IV injection, 370 MBq (10 mCi), single dose', 'armGroupLabels': ['Brain flortaucipir PET scan', 'Whole body flortaucipir PET scan']}, {'name': 'Brain PET Scan', 'type': 'PROCEDURE', 'description': 'positron emission tomography (PET) scan of the brain starting immediately after administration (60 minute dynamic imaging plus 4 frames x 5 minutes at approximately 80 minutes post-dose).', 'armGroupLabels': ['Brain flortaucipir PET scan', 'MRI and Amyloid Extension Cohort']}, {'name': 'Whole body PET scan', 'type': 'PROCEDURE', 'description': 'positron emission tomography (PET) scan of the body from the vertex of the head to the thighs starting immediately following injection and repeated over 6 hours', 'armGroupLabels': ['Whole body flortaucipir PET scan']}, {'name': 'Florbetapir F 18', 'type': 'DRUG', 'otherNames': ['Amyvid'], 'description': 'IV injection, 370 MBq (10 mCi), single dose', 'armGroupLabels': ['Brain flortaucipir PET scan', 'MRI and Amyloid Extension Cohort']}, {'name': 'Brain MRI', 'type': 'PROCEDURE', 'description': 'Volume-based T1-weighted Magnetic Resonance Imaging (MRI) of the brain', 'armGroupLabels': ['Brain flortaucipir PET scan', 'MRI and Amyloid Extension Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90630', 'city': 'Cypress', 'state': 'California', 'country': 'United States', 'facility': 'WCCT Global, LLC', 'geoPoint': {'lat': 33.81696, 'lon': -118.03729}}, {'zip': '92658', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Hoag Memorial Hospital Presbyterian', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avid Radiopharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avid Radiopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}