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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
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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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
1,656 Previous Clinical Trials
2,444,213 Total Patients Enrolled
National Institute on Aging (NIA)NIH
1,803 Previous Clinical Trials
28,194,351 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You cannot have an MRI or PET scan for medical reasons.You are currently participating in a different research study about amyloid-PET at UAB-ADC.I am not pregnant or have been menopausal for over a year or am surgically sterilized.You are a UAB-ADC study participant.\n
Research Study Groups:
This trial has the following groups:- Group 1: [F-18]AV-1451-PET/MRI
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.