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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
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

AV1451 ADC Trial 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.Check my eligibility
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.See study design
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.

AV1451 ADC Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not pregnant or have been menopausal for over a year or am surgically sterilized.

AV1451 ADC Trial Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Measurement of pathological tau deposition in the brain.

AV1451 ADC 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.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

University of Alabama at BirminghamLead Sponsor
1,571 Previous Clinical Trials
2,269,251 Total Patients Enrolled

Media Library

[F-18]AV-1451-PET Clinical Trial Eligibility Overview. Trial Name: NCT03809351 — Phase 1
Alzheimer's Disease Research Study Groups: [F-18]AV-1451-PET/MRI
Alzheimer's Disease Clinical Trial 2023: [F-18]AV-1451-PET Highlights & Side Effects. Trial Name: NCT03809351 — Phase 1
[F-18]AV-1451-PET 2023 Treatment Timeline for Medical Study. Trial Name: NCT03809351 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are enrolled in this medical experiment?

"Affirmative. According to clinicaltrials.gov, this trial has been open since July 8th 2020 and is still recruiting patients today. The research team aims to enrol 160 individuals from a single medical centre."

Answered by AI

Is this study still recruiting participants?

"Indeed. According to the information available on clinicaltrials.gov, this study has been open for recruitment since July 8th 2020 and is actively seeking participants as recently updated on July 21st 2022. The goal of this project is to enroll 160 individuals from a single centre."

Answered by AI

Is [F-18]AV-1451-PET a reliable method of imaging with minimal risks?

"Limited clinical data exists supporting both the safety and efficacy of [F-18]AV-1451-PET, thus it earned a score of 1."

Answered by AI

Who else is applying?

What state do they live in?
Alabama
How old are they?
65+
What site did they apply to?
UAB
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
~40 spots leftby Jul 2025