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Tau PET Imaging for Alzheimer's Disease (AV1451 ADC Trial)

Phase 1

Recruiting

Research Sponsored by University of Alabama at Birmingham

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is measuring the concentration of pathologic tau deposition in the brain using the PET tracer AV-1451 in participants in the UAB-ADC cohort in order to correlate it with demographic, clinical, genetic, and biospecimen data. The primary outcome of this imaging study is to assess interactions between race and vascular risk factors, brain tau levels measured with AV-1451-PET, and cognitive status.

Who is the study for?

This trial is for individuals already enrolled in the UAB-ADC study, focusing on Alzheimer's Disease. Participants must also be part of an amyloid-PET substudy but don't need to have completed it. Women capable of childbearing must test negative for pregnancy. Those with severe dementia or conditions preventing MRI/PET scans cannot join.

What is being tested?

[F-18]AV-1451-PET imaging is being tested to measure and map tau protein deposits in the brain, which are linked to Alzheimer's. The results will be analyzed alongside demographic, clinical, genetic data from the UAB-ADC cohort to understand how race and vascular risks affect cognitive status.

What are the potential side effects?

While specific side effects are not listed here, PET imaging generally has minimal side effects such as discomfort from lying still during scanning or reactions at injection sites; however individual experiences may vary.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Measurement of pathological tau deposition in the brain.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: [F-18]AV-1451-PET/MRIExperimental Treatment1 Intervention

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.

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