11C-M503 PET for Parkinson's (NCT06303921)
Image abnormal brain protein deposits
- Trial ID
- NCT06303921
- Official Title
- Center Without Walls for Imaging Proteinopathies With PET (CW2IP2): Phase I Pilot Study of Biodistribution, Metabolism, Excretion and Brain Uptake of 11C-M503
- Goal
- Image abnormal brain protein deposits
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- University of Pennsylvania
- Study Type
- INTERVENTIONAL
- Enrollment
- 70 participants
- Conditions
- Tauopathies
- Interventions
- 11C-M503 PET, Brain MRI, Amyloid PET, Neurological assessments
Summary For Families
Goal: The team is testing whether a new PET tracer, 11C-M503, can safely reach the brain and highlight abnormal protein deposits like tau that are linked to PSP, MSA, and other tauopathies. Approach: Participants will have PET scans with 11C-M503 plus MRI, amyloid PET and neurological exams while researchers measure how the tracer is distributed, metabolized, excreted, and taken up in the brain; 11C-M503 is a radioactive imaging ligand meant to reveal protein aggregates and is diagnostic only, so it should not affect treatments like levodopa. Eligibility: Adults aged 40 to 85 are being enrolled, including people with clinical diagnoses of Parkinson disease, MSA, PSP, and healthy controls, who can provide consent or have a study partner; pregnant or breastfeeding women are excluded.
Locations
- Yale New Haven Hospital, New Haven, Connecticut, United States
- Washington University in St. Louis, St Louis, Missouri, United States
- University of Pennsylvania, Philadelphia, Pennsylvania, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying 11C-M503 PET. Goal: The team is testing whether a new PET tracer, 11C-M503, can safely reach the brain and highlight abnormal protein deposits like tau that are linked to PSP, MSA, and other tauopathies. Approach: Participants will have PET scans with 11C-M503 plus MRI, amyloid PET and neurological exams while researchers measure how the tracer is distributed, metabolized, excreted, and taken up in the brain; 11C-M503 is a radioactive imaging ligand meant to reveal protein aggregates and is diagnostic only, so it should not affect treatments like levodopa. Eligibility: Adults aged 40 to 85 are being enrolled, including people with clinical diagnoses of Parkinson disease, MSA, PSP, and healthy controls, who can provide consent or have a study partner; pregnant or breastfeeding women are excluded.
- Who can participate?
- Participants must be between 40 Years and 85 Years.
- Where is this trial located?
- This trial is recruiting at 3 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 1 trial is estimated to last approximately 5 years.
- 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.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Injection (minimally invasive); Blood draw (minimally invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.