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NCT03809351PHASE1RecruitingAccepts Healthy Volunteers

UAB Alzheimer's Disease Center Core Cohort - Tau Imaging Substudy

University of Alabama at Birmingham

Start Date

7/8/2020

Completion Date

7/1/2028

Summary

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.

Eligibility Criteria

Age Range: 50 years to No maximum

Inclusion Criteria: 1. Enrollment in the UAB-ADC study under a separate IRB-approved research protocol. 2. 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. 3. 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. Exclusion Criteria: 1. Meets any exclusion criteria for the UAB-ADC study. 2. Inability or contraindication for undergoing MRI and/or PET imaging 3. Inability to participate in the imaging studies due to severity of dementia

Interventions

DRUG

[F-18]AV-1451-PET

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Conditions

Alzheimer Disease

Locations

UAB

Birmingham, Alabama 35233

United States