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

ConditionAlzheimer Disease

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age50+

SponsorUniversity of Alabama at Birmingham

About this trial

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

Qualifiers

Enrollment in the UAB-ADC study under a separate IRB-approved research protocol.

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.

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.

Disqualifiers

Meets any exclusion criteria for the UAB-ADC study.

Inability or contraindication for undergoing MRI and/or PET imaging

Inability to participate in the imaging studies due to severity of dementia

Trial design

Treatments tested in this trial

[F-18]AV-1451-PET

Treatment groups

160 Participants

are divided into 1 treatment group

Sponsors and collaborators

University of Alabama at Birmingham

Lead sponsor

National Institute on Aging (NIA)

Collaborator

Source ClinicalTrials.gov