What this study is
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.
What's being tested
- [F-18]AV-1451-PET
Intervention · 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.
Study details
- Sponsor
- University of Alabama at Birmingham
- Conditions
- Alzheimer Disease
- Enrolling
- 160 people
- Starts
- 2020-07-08
- Est. completion
- 2028-07
- Design
- Open-label, single group, Phase 1
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 50 Years and overSex ALLHealthy volunteers AcceptedYou may qualify if
- 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.
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 open- Recruiting
Study team
Sponsor
University of Alabama at Birmingham
Study ID IRB-300002780 R19-006
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.