Map Parkinson brain immune activity
- Trial ID
- NCT05205291
- Official Title
- Molecular Imaging of LPS-induced Microglial Activation in Parkinson's Disease (PD). A TSPO PET-MR Imaging Study
- Goal
- Map Parkinson brain immune activity
- Status
- RECRUITING
- Sponsor
- University of Exeter
- Study Type
- OBSERVATIONAL
- Enrollment
- 30 participants
- Conditions
- Neurodegenerative Diseases, Parkinson Disease, REM Sleep Behavior Disorder (iRBD)
- Interventions
- Lipopolysaccharide, PET/MR with [11C]PBR28
Summary For Families
Goal: to see where and how much brain immune cells called microglia become active in Parkinson's disease and in people with REM sleep behavior disorder, by provoking a short, controlled immune response and imaging the brain. Approach: participants receive a small, controlled dose of lipopolysaccharide to trigger innate immune activation, then have PET/MR scans with the tracer [11C]PBR28 which binds the TSPO protein on activated microglia so higher PET signal indicates more neuroinflammation; the protocol includes people who are drug-naïve or who are on stable dopaminergic therapy. Eligibility: looking for adults mainly 50 to 85 years old (iRBD arm may include 40+), including people with Parkinson's, people with iRBD, or healthy controls, who are cognitively intact, free of active inflammatory or major medical conditions, able to undergo MRI and arterial sampling, and who are not low-affinity binders for the PET tracer.
Locations
- University of Exeter, Exeter, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Lipopolysaccharide. Goal: to see where and how much brain immune cells called microglia become active in Parkinson's disease and in people with REM sleep behavior disorder, by provoking a short, controlled immune response and imaging the brain. Approach: participants receive a small, controlled dose of lipopolysaccharide to trigger innate immune activation, then have PET/MR scans with the tracer [11C]PBR28 which binds the TSPO protein on activated microglia so higher PET signal indicates more neuroinflammation; the protocol includes people who are drug-naïve or who are on stable dopaminergic therapy. Eligibility: looking for adults mainly 50 to 85 years old (iRBD arm may include 40+), including people with Parkinson's, people with iRBD, or healthy controls, who are cognitively intact, free of active inflammatory or major medical conditions, able to undergo MRI and arterial sampling, and who are not low-affinity binders for the PET tracer.
- Who can participate?
- Participants must be between 50 Years and 85 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 trial is estimated to last approximately 4 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.