Early longitudinal AV-133 PET imaging in people with prodromal Parkinson's
Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging)
This study will try repeated 18F-AV-133 PET scans over two years to track early brain changes in people with prodromal Parkinson's.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Michael J. Fox Foundation for Parkinson's Research Academic / other |
| Locations | 8 sites (New Haven, Connecticut and 7 other locations) |
| Trial ID | NCT07265596 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults enrolled in the PPMI Clinical program with prodromal Parkinson's who can give informed consent and complete serial PET and clinical visits.
Not a fit: People already diagnosed with Parkinson's, those unable to undergo PET imaging (including pregnant individuals), or those unable to attend follow‑up visits are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this imaging could reveal early dopaminergic loss that helps enable earlier diagnosis, better monitoring, and improved selection and timing for preventive or disease‑modifying therapies.
How similar studies have performed: Prior VMAT2 and other dopaminergic imaging studies have demonstrated the ability to detect early nigrostriatal changes, though longitudinal AV-133 imaging specifically in prodromal cohorts is still relatively limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
New Haven, Connecticut and 7 other locations
- Institute for Neurodegenerative Disorders — New Haven, Connecticut, United States (Recruiting)
- University of Pennsylvania — Philadelphia, Pennsylvania, United States (Recruiting)
- Toronto Western Hospital — Toronto, Ontario, Canada (Not_yet_recruiting)
- Philipps-University of Marburg — Hessen, Germany (Not_yet_recruiting)
- Tel Aviv Sourasky Medical Center — Tel Aviv, Israel (Not_yet_recruiting)
- Radboud University — Nijmegen, Gelderland, Netherlands (Not_yet_recruiting)
- Queen Mary University of London — London, Britain, United Kingdom (Recruiting)
- Newcastle University — Newcastle upon Tyne, Tyne and Wear, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Ken Marek, MD — Institute for Neurodegenerative Disorders
- Study coordinator: Lianne Ramia
- Email: LRamia1@indd.org
- Phone: 203-590-5600
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.