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NCT Number: NCT03809351

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

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.

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Key information

Conditions

Alzheimer Disease Brain Diseases Central Nervous System Diseases Dementia Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

UAB

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

April Riddle

CONTACT

[email protected]

2059346504

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

[F-18]AV-1451-PET

Drug

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 outcomes

  1. Measurement of pathological tau deposition in the brain.

    Time frame: 5 years

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Carol Chambless

CONTACT

[email protected]

(205) 975-9569

Chinara Dosse

CONTACT

[email protected]

(205) 934-4501

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Acronym: AV1451 ADC

Important dates

Study start
2020
Primary completion
2028
Study completion
2028
First posted
Jan 18, 2019
Registry last updated
Aug 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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