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PPMI AV-133 Prodromal Imaging Study for Parkinson's Disease

This study is looking at how a special imaging scan, called an [18F]AV-133 PET scan, changes over time in people who have early signs of Parkinson's disease (Prodromal PD). Researchers want to see if these scans can help track the disease's progression before typical symptoms appear. You would be followed for up to 24 months, with scans at the beginning, 12 months, and 24 months. The study aims to enroll about 100 participants who are already part of the PPMI Clinical study and are over 18 years old. The main goal is to measure how much the [18F]AV-133 scan results change and vary over 24 months. The study status is currently unclear regarding recruitment.

Study design
This is an interventional study involving approximately 100 participants. It is a longitudinal, multi-center study.
What's involved
You would undergo [18F]AV-133 PET imaging assessments at baseline, 12 months, and 24 months. You would also have clinical assessments as part of the PPMI Clinical protocol.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to 24 months, with the primary endpoint measured at 24 months.

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NCT07265596

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

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Michael J. Fox Foundation for Parkinson's Research
~100 participants
Updated 2025-12-05 on ClinicalTrials.gov
What's tested:[18F] AV-133 PET Imaging

At a glance

Recruiting sites
4 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
[18F]AV-133 mean rate of change and variability
Measured over 24 months

Conditions

Prodromal Parkinsons Disease

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Parkinson Disease

NCT07265596

Where you'd take part

This study runs at 8 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Institute for Neurodegenerative Disorders

    New Haven, Connecticutstudy coordinator listed

    Recruiting

  • Newcastle University

    Newcastle upon Tyne, Tyne and Wear, United Kingdomstudy coordinator listed

    Recruiting

  • Philipps-University of Marburg

    Hessen, Germanystudy coordinator listed

    Not yet recruiting

  • Queen Mary University of London

    London, Britain, United Kingdomstudy coordinator listed

    Recruiting

  • Radboud University

    Nijmegen, Gelderland, Netherlandsstudy coordinator listed

    Not yet recruiting

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, Israelstudy coordinator listed

    Not yet recruiting

  • Toronto Western Hospital

    Toronto, Ontario, Canadastudy coordinator listed

    Not yet recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Ken Marek, MD · PRINCIPAL_INVESTIGATOR · Institute for Neurodegenerative Disorders

Who to contact

Lianne Ramia
[email protected]
203-590-5600
Email the study team

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Eligibility criteria

Inclusion

Females must be of non-childbearing potential or using a highly effective method of birth control 14 days prior to until at least 24 hours after injection of 18F-AV-133
Non-childbearing potential is defined as a female that must be either postmenopausal (no menses for at least 12 months prior to PET scan) or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy).
Highly effective method of birth control is defined as practicing at least one of the following: A birth control method that results in a less than 1% per year failure rate when used consistently and correctly, such as oral contraceptives for at least 3 months prior to injection, an intrauterine device (IUD) for at least 2 months prior to injection, or barrier methods, e.g., diaphragm or combination condom and spermicide. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) is not acceptable.
Females of childbearing potential must not be pregnant, breastfeeding or lactating.
Includes a negative urine pregnancy test prior to injection of 18F-AV-133 on day of PET scan.

What this trial measures

  • [18F]AV-133 mean rate of change and variability24 months

    The mean rates of change and the variability around the mean of \[18F\]AV-133 PET SUVr in Prodromal PD patients, and where appropriate the comparison of these rates between patient subsets at study intervals ranging from 12 months to 24 months.