Detect Parkinson related brain changes
- Trial ID
- NCT06098612
- Official Title
- PET Imaging Evaluation of [11C]SY08
- Goal
- Detect Parkinson related brain changes
- 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 find out whether a new PET tracer called [11C]SY08 can reliably highlight disease-related brain changes in people with Parkinson's disease, multiple system atrophy, or dementia with Lewy bodies, compared with healthy volunteers. Participants get a single PET/MRI session after injection of the radiolabeled tracer, which is designed to bind to the pathological brain target so researchers can map where and how much signal appears; it is an imaging agent, not a treatment, and it does not change existing medications, so most people must be on stable meds for at least 30 days. The trial is looking for English-speaking adults age 50 to 80, including PD patients at Hoehn and Yahr stages I to IV, people with MSA or probable DLB with mild dementia, and healthy controls, and excludes those with major medical or psychiatric conditions, MRI or PET safety risks, or other listed contraindications.
Locations
- MGH, Charlestown, Massachusetts, United States
Frequently Asked Questions
- What is this trial testing?
- This trial is studying C11-SY08. The goal is to find out whether a new PET tracer called [11C]SY08 can reliably highlight disease-related brain changes in people with Parkinson's disease, multiple system atrophy, or dementia with Lewy bodies, compared with healthy volunteers. Participants get a single PET/MRI session after injection of the radiolabeled tracer, which is designed to bind to the pathological brain target so researchers can map where and how much signal appears; it is an imaging agent, not a treatment, and it does not change existing medications, so most people must be on stable meds for at least 30 days. The trial is looking for English-speaking adults age 50 to 80, including PD patients at Hoehn and Yahr stages I to IV, people with MSA or probable DLB with mild dementia, and healthy controls, and excludes those with major medical or psychiatric conditions, MRI or PET safety risks, or other listed contraindications.
- 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?
- 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 1 trial is estimated to last approximately 2 years and 6 months.
- 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.