Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2026-03-03 @ 2:29 AM
Study NCT ID:
NCT02350634
Status:
COMPLETED
Last Update Posted:
2025-06-10
First Post:
2015-01-08
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
18F-AV-1451 High Resolution Autopsy Study
Sponsor:
Organization:
Raw JSON
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SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. 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Subjects will receive a single IV bolus injection of 370 MBq (10 mCi) of flortaucipir.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'subject survived greater than 6 months following dosing', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Enrollment was opened in June 2015 and closed in May 2018. First patient enrolled in November 2016 and last enrolled patient completed the study procedures in June 2017. Study enrolled end-of-life subjects (life expectancy less than 6 months) at medical centers in the US who consented to a flortaucipir PET scan and to brain donation at autopsy.', 'preAssignmentDetails': 'To be considered eligible for the primary analysis, death had to occur within 6 months of flortaucipir scan and valid autopsy was required.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Enrolled Cohort', 'description': 'End-of-life subjects (life expectancy \\< 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq (10 mCi) of flortaucipir.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '76.00', 'spread': '11.533', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Mini Mental Status Exam (MMSE) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '14.50', 'spread': '20.5061', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'MMSE is an 11-question measure that tests five areas of cognitive function: orientation, registration, attention and calculation, recall, and language. The score ranges from 0 to 30. A score of 23 or lower is indicative of cognitive impairment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'n=2 for cognitively impaired subjects. Cognitively normal subject mental status was not measured.'}, {'title': 'Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.75', 'spread': '0.4330', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': "IQCODE is short questionnaire designed to assess cognitive decline and dementia in elderly people. The questionnaire is filled out by a relative or friend who has known the elderly person for 10 years or more. The result is a score that ranges from 1 to 5. A score of 3 means that the subject is rated on average as 'no change'. A score of 4 means an average of 'a bit worse'. A score of 5 an average of 'much worse'.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'All subjects consenting to flortaucipir PET and brain donation at autopsy'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-11-14', 'size': 615226, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-03-07T16:47', 'hasProtocol': True}, {'date': '2024-11-22', 'size': 362486, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-04-17T14:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-11-26', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2015-01-08', 'resultsFirstSubmitDate': '2025-05-07', 'studyFirstSubmitQcDate': '2015-01-29', 'lastUpdatePostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-05-22', 'studyFirstPostDateStruct': {'date': '2015-01-30', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2025-06-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region', 'timeFrame': 'autopsy within 6 months of scan', 'description': 'Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.'}, {'measure': 'Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region', 'timeFrame': 'autopsy within 6 months of scan', 'description': 'Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of frontal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.'}, {'measure': 'Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region', 'timeFrame': 'autopsy within 6 months of scan', 'description': 'Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of parietal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.'}, {'measure': 'Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region', 'timeFrame': 'autopsy within 6 months of scan', 'description': 'Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.'}, {'measure': 'Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region', 'timeFrame': 'autopsy within 6 months of scan', 'description': 'Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of temporal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.'}, {'measure': 'Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region', 'timeFrame': 'autopsy within 6 months of scan', 'description': 'Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of occipital composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.'}, {'measure': 'Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region', 'timeFrame': 'autopsy within 6 months of scan', 'description': 'Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of limbic composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '34933123', 'type': 'BACKGROUND', 'citation': "Ushizima D, Chen Y, Alegro M, Ovando D, Eser R, Lee W, Poon K, Shankar A, Kantamneni N, Satrawada S, Junior EA, Heinsen H, Tosun D, Grinberg LT. Deep learning for Alzheimer's disease: Mapping large-scale histological tau protein for neuroimaging biomarker validation. Neuroimage. 2022 Mar;248:118790. doi: 10.1016/j.neuroimage.2021.118790. Epub 2021 Dec 20."}]}, 'descriptionModule': {'briefSummary': 'The study is designed to examine the relationship between imaging results detected on a 18F-AV-1451 PET scan and pathology found at autopsy within six months of imaging.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '89 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Projected life expectancy ≤ 6 months\n\nExclusion Criteria:\n\n* Primary brain tumor, known metastases to the brain, central nervous system lymphoma\n* Major, focal structural brain lesion\n* Aggressively being treated with life sustaining measures\n* Clinically significant infectious disease\n* History of risk factors for Torsades de Pointes or are currently taking medication known to cause QT prolongation\n* Have received or participated in a trial with investigational medications in the past 30 days\n* Females of childbearing potential who are pregnant or not using adequate contraception'}, 'identificationModule': {'nctId': 'NCT02350634', 'briefTitle': '18F-AV-1451 High Resolution Autopsy Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Avid Radiopharmaceuticals'}, 'officialTitle': 'A High Resolution Autopsy Study Evaluating the Relationship of 18F-AV-1451 PET Imaging and Tau Pathology', 'orgStudyIdInfo': {'id': '18F-AV-1451-A13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autopsy Cohort', 'description': 'End-of-life subjects (life expectancy \\< 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir F18.', 'interventionNames': ['Drug: Flortaucipir F18']}], 'interventions': [{'name': 'Flortaucipir F18', 'type': 'DRUG', 'otherNames': ['[F-18]T807', '18F-AV-1451'], 'description': 'Subjects will receive a single IV bolus injection of 370 megabecquerel (MBq) (10 millicurie \\[mCi\\]) of flortaucipir.', 'armGroupLabels': ['Autopsy Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85006', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': "Banner Alzheimer's Institute", 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94121', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Avid Radiopharmaceuticals, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Avid Radiopharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}