[18F] AV-133 PET Imaging for Parkinson's (NCT07265596)
Identify brain changes before symptoms
- 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
- Identify brain changes before symptoms
- 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 study is following people in the prodromal stage, when brain changes may be happening but typical Parkinson’s symptoms have not yet started, to see how an imaging marker changes over two years and to help find early progression markers. Participants will have positron emission tomography (PET) scans using a tracer called [18F] AV-133 that targets the vesicular monoamine transporter in the brain, plus yearly clinical tests of movement, mood, thinking, and other biomarkers at baseline, 12 months, and 24 months. About 100 adults over 18 from the Parkinson’s Progression Marker Initiative prodromal cohort will be enrolled across up to 10 sites; participants must be able to consent, women must meet pregnancy and birth-control rules, and people who took certain medications that interfere with the scan within one month (for example tetrabenazine, methylphenidate, reserpine, or amphetamine-like drugs) are excluded.
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 study is following people in the prodromal stage, when brain changes may be happening but typical Parkinson’s symptoms have not yet started, to see how an imaging marker changes over two years and to help find early progression markers. Participants will have positron emission tomography (PET) scans using a tracer called [18F] AV-133 that targets the vesicular monoamine transporter in the brain, plus yearly clinical tests of movement, mood, thinking, and other biomarkers at baseline, 12 months, and 24 months. About 100 adults over 18 from the Parkinson’s Progression Marker Initiative prodromal cohort will be enrolled across up to 10 sites; participants must be able to consent, women must meet pregnancy and birth-control rules, and people who took certain medications that interfere with the scan within one month (for example tetrabenazine, methylphenidate, reserpine, or amphetamine-like drugs) are excluded.
- 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?
- You are never charged a fee to join a legitimate clinical trial, and the study treatment and study-specific tests are provided by the trial sponsor at no charge. In the US, routine care you would receive anyway can still be billed to you or your insurance; coverage rules differ by country, and trials in the UK and Canada usually run through public health systems. Travel, parking, and time are real costs, and some trials reimburse them while others do not. Before enrolling, ask the study coordinator to explain in writing what is and is not covered.
- How long does the trial last?
- This Phase 2 trial is estimated to last approximately 4 years and 1 month.
- 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.
- 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.
- Will I get a placebo in this trial?
- Everyone in this trial receives the experimental treatment. There is no placebo group.
- How many visits does this trial involve?
- You will have 3 imaging visits over 24 months.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive). Confirm the full schedule with the study coordinator.