C11-SY08 for Parkinson's (NCT06098612)
Find protein clumps in people
- Trial ID
- NCT06098612
- Official Title
- PET Imaging Evaluation of [11C]SY08
- Goal
- Find protein clumps in people
- Phase
- EARLY_PHASE1
- Status
- RECRUITING
- Sponsor
- Massachusetts General Hospital
- Study Type
- INTERVENTIONAL
- Enrollment
- 40 participants
- Conditions
- Parkinson's Disease, Multiple System Atrophy, Dementia With Lewy Bodies, Healthy Controls
- Interventions
- C11-SY08
Summary For Families
The goal is to see whether a new imaging tracer called SY08 can show clumps of the protein alpha-synuclein in the brains of people with Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and in healthy volunteers. Participants get a single injection of SY08 into a vein and then have brain scans with PET (positron emission tomography) and MRI so researchers can measure how the tracer enters and moves through the brain and estimate the radiation dose. The study is looking for adults age 50 to 80, including people with diagnosed Parkinson's, MSA, or DLB who are on stable medications and can bring a study partner, plus healthy controls; everyone must be able to read English, give consent, lie still for the scan, and meet MRI and PET safety rules.
Locations
- MGH, Charlestown, Massachusetts, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying C11-SY08. The goal is to see whether a new imaging tracer called SY08 can show clumps of the protein alpha-synuclein in the brains of people with Parkinson's disease, multiple system atrophy, dementia with Lewy bodies, and in healthy volunteers. Participants get a single injection of SY08 into a vein and then have brain scans with PET (positron emission tomography) and MRI so researchers can measure how the tracer enters and moves through the brain and estimate the radiation dose. The study is looking for adults age 50 to 80, including people with diagnosed Parkinson's, MSA, or DLB who are on stable medications and can bring a study partner, plus healthy controls; everyone must be able to read English, give consent, lie still for the scan, and meet MRI and PET safety rules.
- Who can participate?
- Participants must be between 50 Years and 80 Years.
- Where is this trial located?
- This trial is recruiting at 1 location.
- 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 2 years and 6 months.
- 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?
- One in-person PET/MRI scanning session is required.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Intravenous infusion (minimally invasive); Injection (minimally invasive). Confirm the full schedule with the study coordinator.