Early longitudinal AV-133 PET imaging in people with prodromal Parkinson's

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multi-center, longitudinal imaging project embedded in the PPMI clinical protocol enrolling about 100 prodromal Parkinson's participants and following them for up to 24 months. Participants receive baseline and repeat 18F-AV-133 PET scans at 12 and 24 months targeting the vesicular monoamine transporter (VMAT2) to measure nigrostriatal integrity. Clinical, cognitive, neuropsychiatric, and other biomarker assessments are collected in parallel under the PPMI framework. The goal is to characterize longitudinal imaging changes before typical motor symptoms appear to improve biomarker signatures for early disease.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. A Prodromal PD participant, over the age of 18, confirmed as eligible to proceed to PPMI Clinical Baseline visit.
2. Able to provide informed consent.
3. Male or Female (females must meet additional criteria specified below as applicable)

   * 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.

Exclusion Criteria:

1. Received any of the following medications that might interfere with 18F- AV-133 PET imaging: tetrabenazine (TBZ) or methylphenidate, reserpine, or amphetamine derivative, within 1 month prior to the Baseline 18F-AV-133 injection.
2. Any other medical or psychiatric condition or lab abnormality, which in the opinion of the investigator might preclude participation.

Where it's running

• Institute for Neurodegenerative Disorders
  New Haven, Connecticut, United States Recruiting
• University of Pennsylvania
  Philadelphia, Pennsylvania, United States Recruiting
• Queen Mary University of London
  London, Britain, United Kingdom Recruiting
• Newcastle University
  Newcastle upon Tyne, Tyne and Wear, United Kingdom Recruiting
• Toronto Western Hospital
  Toronto, Ontario, Canada Not yet recruiting
• Philipps-University of Marburg
  Hessen, Germany Not yet recruiting

Study contacts

• Principal investigator: Ken Marek, MD — Institute for Neurodegenerative Disorders
• Study coordinator: Lianne Ramia
• Email: LRamia1@indd.org
• Phone: 203-590-5600

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.