dapansutrile for Parkinson's (NCT07157735)
Reduce brain and spinal inflammation
- Trial ID
- NCT07157735
- Official Title
- Anti-inflammatory Intervention With Dapansutrile (OLT1177®) for Parkinson's Disease Modification (DAPA-PD): A Randomised Double-Blind, Placebo-Controlled Phase II Trial
- Goal
- Reduce brain and spinal inflammation
- Phase
- PHASE2
- Status
- RECRUITING
- Sponsor
- Cambridge University Hospitals NHS Foundation Trust
- Study Type
- INTERVENTIONAL
- Enrollment
- 36 participants
- Conditions
- Parkinson Disease
- Interventions
- dapansutrile, placebo
Summary For Families
The goal is to see whether dapansutrile, a new medication that blocks a protein complex inside cells that drives inflammation, is safe in people with Parkinson's and can lower inflammation in the brain, spinal fluid, and blood, with symptom changes also tracked; earlier small human studies suggest it can reduce inflammation without major side effects. Participants take dapansutrile 1000 mg twice a day or a look-alike placebo for six months, then can choose to take the real drug for another six months, while researchers monitor safety with blood tests and heart checks, do a special brain scan that shows inflammation, and collect spinal fluid with a lumbar puncture (spinal tap) to measure inflammatory markers. The study will recruit 36 people aged 50 to 80 who have early, mild Parkinson's (symptoms for less than five years and early-stage on standard scales), who have a blood test showing some inflammation (high sensitivity C-reactive protein, hsCRP, above 1 mg/L), and who are either not yet on Parkinson's drugs or are on a stable dose of Parkinson's medicines such as levodopa. The trial is randomized and double-blind, with more participants assigned to the active drug than to placebo.
Locations
- John Van Geest Centre for Brain Repair, Cambridge, United Kingdom
Frequently Asked Questions
- What is this trial testing?
- This trial is studying dapansutrile. The goal is to see whether dapansutrile, a new medication that blocks a protein complex inside cells that drives inflammation, is safe in people with Parkinson's and can lower inflammation in the brain, spinal fluid, and blood, with symptom changes also tracked; earlier small human studies suggest it can reduce inflammation without major side effects. Participants take dapansutrile 1000 mg twice a day or a look-alike placebo for six months, then can choose to take the real drug for another six months, while researchers monitor safety with blood tests and heart checks, do a special brain scan that shows inflammation, and collect spinal fluid with a lumbar puncture (spinal tap) to measure inflammatory markers. The study will recruit 36 people aged 50 to 80 who have early, mild Parkinson's (symptoms for less than five years and early-stage on standard scales), who have a blood test showing some inflammation (high sensitivity C-reactive protein, hsCRP, above 1 mg/L), and who are either not yet on Parkinson's drugs or are on a stable dose of Parkinson's medicines such as levodopa. The trial is randomized and double-blind, with more participants assigned to the active drug than to placebo.
- 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 2 trial is estimated to last approximately 1 year and 3 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 trial has 2 groups, and 1 is a placebo group. Because assignment is random, you have about a 1 in 2 chance (roughly 50%) of being in the placebo group, assuming the groups are filled equally. Ask the coordinator to confirm the exact assignment ratio.
- What procedures are involved in this trial?
- Based on the protocol, this trial involves: Lumbar puncture (spinal tap) (invasive); Blood draw (minimally invasive); PET scan (minimally invasive); Heart tracing (ECG) (non-invasive). Confirm the full schedule with the study coordinator.
- Is there a medication washout in this trial?
- Some medications that interfere with PET imaging can be safely withheld for an appropriate washout period before imaging, at the investigator's discretion.