Reduce neuroinflammation and slow progression
- 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 neuroinflammation and slow progression
- 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 slow or modify early Parkinson's by reducing harmful brain inflammation that may drive nerve cell damage and symptom progression. The approach gives oral dapansutrile (OLT1177) versus placebo; dapansutrile blocks the NLRP3 inflammasome to lower inflammatory cytokines like IL-1β and IL-18, aiming to dampen microglial-driven inflammation, and it is tested alongside usual care so people can be drug-naive or remain on a stable dopaminergic regimen. They are looking for people aged 50 to 80 with clinically established early PD under 5 years and Hoehn and Yahr stage ≤2, who have hsCRP >1 mg/L, and who meet safety requirements such as no recent immunosuppressive therapy, no active infections or autoimmune disease, and PET-MRI compatibility.
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 slow or modify early Parkinson's by reducing harmful brain inflammation that may drive nerve cell damage and symptom progression. The approach gives oral dapansutrile (OLT1177) versus placebo; dapansutrile blocks the NLRP3 inflammasome to lower inflammatory cytokines like IL-1β and IL-18, aiming to dampen microglial-driven inflammation, and it is tested alongside usual care so people can be drug-naive or remain on a stable dopaminergic regimen. They are looking for people aged 50 to 80 with clinically established early PD under 5 years and Hoehn and Yahr stage ≤2, who have hsCRP >1 mg/L, and who meet safety requirements such as no recent immunosuppressive therapy, no active infections or autoimmune disease, and PET-MRI compatibility.
- 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 2 trial is estimated to last approximately 1 year 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.