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

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

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03809351
Acronym
AV1451 ADC
Enrollment
160
Registered
2019-01-18
Start date
2020-07-08
Completion date
2028-07-01
Last updated
2026-08-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer Disease

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.

Interventions

DRUG[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.

Sponsors

University of Alabama at Birmingham
Lead SponsorOTHER
National Institute on Aging (NIA)
CollaboratorNIH

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Measurement of pathological tau deposition in the brain.5 yearsThe 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.

Countries

United States

Contacts

CONTACTChinara Dosse
cdosse@uabmc.edu(205) 934-4501
CONTACTCarol Chambless
cchambless@uabmc.edu(205) 975-9569

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 13, 2026