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
Plain-Language Summary
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.