Recruiting
Phase 1

AV-1451

Sponsor:

University of Alabama at Birmingham

Code:

NCT03809351

Conditions

Alzheimer Disease

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

Interventions

[F-18]AV-1451-PET

Study Details

Brief 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.

Conditions

Alzheimer Disease

Study ID

NCT03809351

Start date

Jul 8, 2020

Status verified date

Aug, 2026

Completion date

Jul, 2028

Anticipated

Primary completion date

Jul, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

160 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: [F-18]AV-1451-PET/MRI

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.

Interventions

[F-18]AV-1451-PET

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.

Primary outcome measure

  • Measurement of pathological tau deposition in the brain. [ Time Frame: 5 years ]

Central Contacts and Locations

Central contacts

Chinara Dosse

(205) 934-4501cdosse@uabmc.edu

Carol Chambless

(205) 975-9569cchambless@uabmc.edu

Locations

UAB

Recruiting

Birmingham, Alabama, United States, 35233

Contacts

April Riddle

2059346504ariddle@uabmc.edu

More Information

Sponsor

University of Alabama at Birmingham

Last update posted

Aug 12, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Alabama at Birmingham on 2026-08-12.