RecruitingPhase 2NCT07265596

Early Longitudinal Imaging in the Parkinson's Progressive Marker Initiative (PPMI) Using (18F)AV-133 (PPMI AV-133 Prodromal Imaging)

Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging)


Sponsor

Michael J. Fox Foundation for Parkinson's Research

Enrollment

100 participants

Start Date

Oct 30, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

The study is a longitudinal, multi-center study to assess progression of \[18F\] AV-133 imaging in Prodromal PD participants. Participants will be followed for up to 24 months. Approximately 100 Prodromal participants will be recruited from up to 10 sites. Participants will be comprehensively assessed at baseline and follow up. Participants will undergo imaging assessments with \[18F\] AV-133 and clinical (motor, neuropsychiatric, cognitive and imaging and biomarker) assessments (conducted under the PPMI Clinical protocol).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This imaging study is using a special type of PET scan (with a tracer called 18F-AV-133) to look at dopamine-producing nerve cells in the brain of people who are at high risk of developing Parkinson's disease but haven't been diagnosed yet. It is part of the larger Parkinson's Progression Markers Initiative (PPMI). This is a research imaging study — no new treatment is being tested. **You may be eligible if...** - You are over 18 years old - You are already enrolled in PPMI as a "prodromal" participant (meaning you show early warning signs of Parkinson's but do not yet have a diagnosis) - You are able to provide informed consent - If you are a woman of childbearing age, you must use highly effective contraception or be post-menopausal/surgically sterile **You may NOT be eligible if...** - You have taken certain medications in the past month that interfere with the PET scan (such as tetrabenazine, methylphenidate, reserpine, or amphetamine-type drugs) - You have a medical or psychiatric condition that makes it unsafe or impractical to participate Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG[18F] AV-133 PET Imaging

Prodromal PD participants from the PPMI Clinical (002) study will be followed for up to 24 months. These participants will undergo imaging assessments with \[18F\]AV-133 under this protocol at baseline, 12-month and 24 months.


Locations(8)

Institute for Neurodegenerative Disorders

New Haven, Connecticut, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Toronto Western Hospital

Toronto, Ontario, Canada

Philipps-University of Marburg

Hessen, Germany

Tel Aviv Sourasky Medical Center

Tel Aviv, Israel

Radboud University

Nijmegen, Gelderland, Netherlands

Queen Mary University of London

London, Britain, United Kingdom

Newcastle University

Newcastle upon Tyne, Tyne and Wear, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07265596