Lipopolysaccharide for Parkinson's (NCT05205291)
Measure brain inflammation in Parkinson
- Trial ID
- NCT05205291
- Official Title
- Molecular Imaging of LPS-induced Microglial Activation in Parkinson's Disease (PD). A TSPO PET-MR Imaging Study
- Goal
- Measure brain inflammation in Parkinson
- 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
The goal is to learn whether and how brain inflammation is increased in Parkinson's and what might drive that inflammation. The approach is to take two positron emission tomography scans that use a tracer to highlight inflamed areas of the brain, one before and one after giving a small dose of lipopolysaccharide, a compound that causes a mild inflammatory response; blood samples will also be taken and magnetic resonance imaging will be used to check brain structure. The study is recruiting mostly adults aged about 50 to 85 (some people with a sleep behavior disorder may be eligible from age 40), including people with Parkinson's, people with REM sleep behavior disorder, and healthy volunteers who are cognitively healthy, without active inflammatory or serious medical conditions, and who can follow safety rules like fasting and pregnancy or contraception precautions.
Locations
- University of Exeter, Exeter, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying Lipopolysaccharide. The goal is to learn whether and how brain inflammation is increased in Parkinson's and what might drive that inflammation. The approach is to take two positron emission tomography scans that use a tracer to highlight inflamed areas of the brain, one before and one after giving a small dose of lipopolysaccharide, a compound that causes a mild inflammatory response; blood samples will also be taken and magnetic resonance imaging will be used to check brain structure. The study is recruiting mostly adults aged about 50 to 85 (some people with a sleep behavior disorder may be eligible from age 40), including people with Parkinson's, people with REM sleep behavior disorder, and healthy volunteers who are cognitively healthy, without active inflammatory or serious medical conditions, and who can follow safety rules like fasting and pregnancy or contraception precautions.
- 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?
- 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 trial is estimated to last approximately 4 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?
- This is an observational study, so there is no placebo and no experimental treatment is assigned. Researchers observe and collect information while you continue your usual care.
- How many visits does this trial involve?
- There are two in-person study visits: visit 1 is about 3 hours, and visit 2 occurs over two consecutive days with the PET visit day lasting around 8 hours.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: PET scan (minimally invasive); Injection (minimally invasive); Questionnaires & surveys (non-invasive); MRI scan (non-invasive). Confirm the full schedule with the study coordinator.