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
Summary For Families
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.
- Will I get the real drug or a placebo?
- It depends on the trial design. Some Parkinson's trials are placebo controlled, meaning a portion of participants get an inactive comparison while others get the experimental treatment. Some use crossover designs so everyone eventually receives the active treatment at some point. Observational trials do not use a placebo at all because they are not testing a new treatment. The consent form for any specific trial spells out the design and your odds of being assigned to placebo before you enroll.
- How often will I need to visit the study site?
- Visit frequency varies by trial. Many Parkinson's studies require an in person visit every 4 to 12 weeks during the active treatment phase, with shorter or longer gaps depending on the design. The site coordinator can give you the full visit schedule before you sign anything, so you know what the time commitment looks like.
- Can I leave the trial if I change my mind?
- Yes. You can withdraw from any clinical trial at any time, for any reason, without affecting your standard medical care. Trials are voluntary by law. The team may ask if you are willing to do a brief exit visit so they can collect safety information, but you are not obligated.
- Will travel or parking be reimbursed?
- Many trials reimburse for parking, mileage, and sometimes lodging if the site is far from your home. Reimbursement policies vary by sponsor and site. When you contact the trial team, ask specifically what is covered and how reimbursement is processed.
- Can my spouse or care partner come with me to visits?
- In most cases yes, and it is often encouraged. Care partners can help with notes, questions, and getting home safely after a long visit. Some study assessments do need to happen one on one, but care partners are usually welcome for the rest of the appointment.