A Phase 1 interventional study of [F-18]AV-1451-PET in Alzheimer Disease, sponsored by University of Alabama at Birmingham. Recruiting at 1 site in United States. Open to participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by University of Alabama at Birmingham · Phase 1, Interventional, and Diagnostic
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's planned enrollment of 160 is above the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →University of Alabama at Birmingham is the lead sponsor of 1,396 studies on the registry; 284 are open to participants now.
Of its 156 completed or terminated interventional studies of FDA-regulated products, 124 (79%) have results posted.
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Exclusion Criteria:
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.
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.
Measurement of pathological tau deposition in the brain.
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.
Time frame: 5 years
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University of Alabama at Birmingham