At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- dapansutrile (drug), placebo (drug)
- How long the study runs
- Study runs about 28 months (dates as stated)
- About the drug or intervention
- dapansutrile — drug: Dapansutrile tablets administered for 26 weeks, starting at 1,000 mg daily (500 mg twice daily) for 4 weeks, escalated to 2,000 mg daily (1,000 mg twice daily) thereafter. · placebo — drug: Matched placebo tablets administered for 26 weeks, admistered as per the active treatment.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 50 Years to 80 Years
- Who
- All
- Number of participants
- 36
- Started
- 2026-02-02
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for parkinson disease
- • Phase2 - 36 participants
- • In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease
Who can take part?
- • Ages 50 Years to 80 Years
- • Diagnosed with parkinson disease
Where?
- • Cambridge - John Van Geest Centre for Brain Repair
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
In Parkinson's disease (PD), there is inflammation in the brain, the gut and the blood, which is thought to contribute to the development and progression of the disease. The Nod-like receptor (NLR) family pyrin domain containing 3 (NLRP3) inflammasome is a complex of proteins which plays a critical role in mediating inflammation, and there is growing evidence from laboratory research that the inflammasome plays a role in Parkinson's disease. Dapansutrile is a new drug which has a highly specific effect on the NLRP3 inflammasome. In animal models, dapansutrile can protect against inflammation in the brain and prevent loss of dopamine cells. Initial 'in human' studies have indicated that this drug can effectively reduce inflammation without causing significant side effects. The goal of this clinical trial is to test whether dapansutrile might be a useful treatment for Parkinson's disease. The main questions it aims to answer are: 1. is dapansutrile safe and well-tolerated in people with Parkinson's? 2. does dapansutrile reduce inflammation in the brain, cerebrospinal fluid (CSF) and blood? Changes in clinical symptoms will also be measured over the course of the trial. Researchers will compare dapansutrile to a placebo (a look-alike substance that contains no drug) to see whether it is safe and what effects it has on inflammation and on clinical symptoms. Participants will be asked to take dapansutrile or a placebo every day for 6 months. Following this, all participants will be given the option to take dapansutrile every day for an additional 6 months. Participants will visit the study centre regularly throughout the trial for check-ups and blood tests. They will have a brain scan before starting treatment and again after 5-6 months. They will also be asked to have a lumbar puncture at the beginning of the trial, after 6 months of treatment and after 12 months of treatment.
More detail
DAPA-PD is a randomised double-blind, placebo-controlled phase II trial investigating the safety and tolerability of dapansutrile (OLT1177), an NLRP3 inhibitor, in people with early PD (Hoehn and Yahr stage ≤2, disease duration ≤5 years) who have evidence of peripheral inflammation (high sensitivity C-reactive protein \[hsCRP\] ≥1) as an adjunct to dopaminergic therapies. 36 participants will be recruited at a single site and treated with either dapansutrile (1000mg twice daily) or placebo in a 2:1 ratio for a duration of 6 months. This randomised placebo-controlled phase of the trial will be followed by an optional 6-month open label phase, where all participants will receive the active drug. The primary endpoint will be the safety and tolerability of dapansutrile over the 6-month placebo-controlled phase. Safety data will be collected throughout both phases of the trial, through venous blood sampling, electrocardiograms and clinical assessments. The trial will assess treatment efficacy on peripheral and central inflammation, using biomarkers in blood and CSF, and translocator protein (TSPO) positron emission tomography (PET) brain imaging. Pharmacokinetics of the drug will also be evaluated. Additionally, clinical outcomes, including motor and cognitive progression, will be assessed throughout.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 50 Years - 80 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓To be included in the trial, the potential participant must:
- ✓Have given written agreement to take part to participate.
- ✓Be aged between 50 and 80 years (inclusive) at the time of the screening visit.
- ✓Be a fluent English speaker.
- ✓Have a diagnosis of clinically established early PD according to the Movement Disorder Society Criteria for...
Who cannot take part
- ✗The presence of any of the following will preclude inclusion:
- ✗Low affinity binder for TSPO ligands based on genotyping for single nucleotide polymorphism (SNP) rs6971.
- ✗Any previous use of rituximab or alemtuzumab at any time.
- ✗Regular use of non-steroidal anti-inflammatory drugs (NSAIDs) - including aspirin \> 75 mg, naproxen, ibuprofen and...
- ✗Clinically significant inflammatory or autoimmune disease.
See the full criteria
Where Is This Study? (1 UK site)
John Van Geest Centre for Brain Repair
Cambridge CB2 0PY, United Kingdom
How to Get in Touch
Trial Coordinator
Sponsor contactCONTACT
