Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2026-01-02 @ 8:15 AM
Study NCT ID:
NCT03809351
Status:
RECRUITING
Last Update Posted:
2025-12-11
First Post:
2019-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-07-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-04', 'studyFirstSubmitDate': '2019-01-14', 'studyFirstSubmitQcDate': '2019-01-15', 'lastUpdatePostDateStruct': {'date': '2025-12-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2019-01-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Measurement of pathological tau deposition in the brain.', 'timeFrame': '5 years', 'description': 'The amount and regional distribution of pathological tau in the brains of study participants will be measured with \\[F-18\\]AV-1451-PET/MRI using standardized uptake value ratios (SUVRs) derived from the PET images.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alzheimer Disease']}, 'descriptionModule': {'briefSummary': 'The primary objective of this study is to measure the concentration and the regional brain distribution of pathologic tau deposition using the PET tracer AV-1451 in participants in the UAB-ADC cohort. The amount and distribution of AV-1451 in the brain will be correlated to demographic, clinical, genetic, and biospecimen data acquired through the separate ongoing UAB-ADC study. Assessment of interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status will be the primary outcome of this imaging study. Individuals participating in this AV-1451-PET/MRI study will also be enrolled in an ongoing \\[C-11\\]PiB-PET/MRI study (IRB-300001005, IND-138128), and their amyloid, tau and cognitive statuses will be compared in terms of race and vascular risk factors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.\n2. Enrollment in the UAB-ADC amyloid-PET substudy under a separate IRB-approved research protocol. The amyloid-PET study does not have to have been completed prior to enrollment and participation in this tau-PET study.\n3. Negative urine or serum hCG test within 2 days of \\[F-18\\]AV-1451 administration in women of child bearing potential. Women who are post-menopausal with at least 1 year since last menses or documented surgical sterilization will not require pregnancy testing.\n\nExclusion Criteria:\n\n1. Meets any exclusion criteria for the UAB-ADC study.\n2. Inability or contraindication for undergoing MRI and/or PET imaging\n3. Inability to participate in the imaging studies due to severity of dementia'}, 'identificationModule': {'nctId': 'NCT03809351', 'acronym': 'AV1451 ADC', 'briefTitle': "UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy", 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': "UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy", 'orgStudyIdInfo': {'id': 'R19-006'}, 'secondaryIdInfos': [{'id': '1P30AG086401-01', 'link': 'https://reporter.nih.gov/quickSearch/1P30AG086401-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[F-18]AV-1451-PET/MRI', 'description': 'All participants in this study will undergo a tau-PET imaging using the tracer \\[F-18\\]AV-1451 with a simultaneous PET/MRI system. The \\[F-18\\]AV-1451 dosage is 740MBq (10 mCi) given intravenously, and the PET/MRI imaging will occur 75-105 min after tracer injection.', 'interventionNames': ['Drug: [F-18]AV-1451-PET']}], 'interventions': [{'name': '[F-18]AV-1451-PET', 'type': 'DRUG', 'description': 'All study participants will undergo brain imaging with \\[F-18\\]AV-1451-PET/MRI. \\[F-18\\]AV-1451 is a PET imaging agent used primarily to measure the amount of abnormal tau protein deposition the brain.', 'armGroupLabels': ['[F-18]AV-1451-PET/MRI']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'April Riddle', 'role': 'CONTACT', 'email': 'ariddle@uabmc.edu', 'phone': '2059346504'}], 'facility': 'UAB', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'centralContacts': [{'name': 'Chinara Dosse', 'role': 'CONTACT', 'email': 'cdosse@uabmc.edu', 'phone': '(205) 934-4501'}, {'name': 'Carol Chambless', 'role': 'CONTACT', 'email': 'cchambless@uabmc.edu', 'phone': '(205) 975-9569'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director, Division of Molecular Imaging and Therapeutics', 'investigatorFullName': 'Jonathan E McConathy', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}