Detect early dopamine nerve loss
- Trial ID
- NCT07265596
- Official Title
- Early Longitudinal Imaging in the Parkinson's Progression Markers Initiative Using [18F] AV-133 (PPMI AV-133 Prodromal Imaging)
- Goal
- Detect early dopamine nerve loss
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Michael J. Fox Foundation for Parkinson's Research
- Study Type
- INTERVENTIONAL
- Enrollment
- 100 participants
- Conditions
- Prodromal Parkinsons Disease
- Interventions
- [18F] AV-133 PET Imaging
Plain-Language Summary
The goal is to see whether PET scans using [18F] AV-133 can detect early loss of dopamine nerve terminals and track progression in people in the prodromal stage of Parkinson's. The approach uses a radioactive tracer that binds the VMAT2 protein on dopamine nerve terminals, so areas with fewer terminals light up on PET images; the scan is diagnostic and does not treat Parkinson's or change levodopa effects, though certain drugs that affect VMAT2 or dopamine storage can blur the picture, for example tetrabenazine, reserpine, methylphenidate, or amphetamine derivatives. The study is enrolling adults 18 and older who are confirmed prodromal PD participants headed to the PPMI clinical baseline visit and who can give informed consent, with extra rules for women of childbearing potential such as effective contraception and a negative pregnancy test. People on interfering medications or with other medical or psychiatric issues that could affect participation are excluded at the investigator's discretion.
Locations
- 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
Frequently Asked Questions
- What is this trial testing?
- This trial is studying [18F] AV-133 PET Imaging. The goal is to see whether PET scans using [18F] AV-133 can detect early loss of dopamine nerve terminals and track progression in people in the prodromal stage of Parkinson's. The approach uses a radioactive tracer that binds the VMAT2 protein on dopamine nerve terminals, so areas with fewer terminals light up on PET images; the scan is diagnostic and does not treat Parkinson's or change levodopa effects, though certain drugs that affect VMAT2 or dopamine storage can blur the picture, for example tetrabenazine, reserpine, methylphenidate, or amphetamine derivatives. The study is enrolling adults 18 and older who are confirmed prodromal PD participants headed to the PPMI clinical baseline visit and who can give informed consent, with extra rules for women of childbearing potential such as effective contraception and a negative pregnancy test. People on interfering medications or with other medical or psychiatric issues that could affect participation are excluded at the investigator's discretion.
- Who can participate?
- Participants must be at least 18 Years.
- Where is this trial located?
- This trial is recruiting at 8 locations.
- Does it cost anything to join?
- No. There is no cost to participate. Study-related care and treatment are provided at no charge.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 4 years and 1 month.