Actively Recruiting
A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease
Led by Cambridge University Hospitals NHS Foundation Trust · Updated on 2026-02-27
36
Participants Needed
1
Research Sites
104 weeks
Total Duration
On this page
Sponsors
C
Cambridge University Hospitals NHS Foundation Trust
Lead Sponsor
U
University of Cambridge
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Written informed consent given
- Age between 50 and 80 years inclusive at screening
- Fluent English speaker
- Diagnosis of clinically established early Parkinson's disease
- Disease duration less than 5 years at screening
- Early-stage Parkinson's disease (Hoehn and Yahr stage 2)
- Parkinson's disease drug naive or stable dopaminergic therapy for at least 3 months prior to screening or between screening and baseline
- High sensitivity C-reactive protein (hsCRP) greater than 1 mg/L at screening
- Adequate organ function: Hemoglobin 20 g/L; Platelets 20 x 109/L; Neutrophils 2.5 x 109/L; eGFR 2.5 mL/min/1.73m2; ALT and bilirubin less than 1.5 times upper normal limit; Normal thyroid stimulating hormone; Corrected calcium within normal range; ALP less than 1.5 times upper normal limit
You will not qualify if you...
- Low affinity binder for TSPO ligands by SNP rs6971 genotyping
- Use of immunomodulatory or biologic drugs within 12 months prior or between screening and baseline
- Any previous rituximab or alemtuzumab use
- Oral corticosteroids for over 2 weeks within 12 months prior or steroid use within 3 months prior or between screening and baseline
- Regular use of NSAIDs on more than 2 days per week
- Known inflammatory or autoimmune disease
- Chronic or latent infection
- Severe infection requiring parenteral antimicrobials within 2 months prior or between screening and baseline
- Skin, solid organ, or hematological cancer within 5 years prior or between screening and baseline
- Unable to take or swallow oral medication
- Parkinson's Disease Dementia
- Known genetic mutation linked to Parkinson's disease
- Positive test for HIV, hepatitis B/C, or syphilis
- Chronic liver disease
- Any medical or psychiatric condition interfering with trial or posing risk
- Women of childbearing potential not surgically sterile or post-menopausal
- Men not surgically sterile or unwilling to use contraception during and 6 months after treatment
- Known allergy to dapansutrile or excipients
- Participation in other investigational drug/device trials within 12 weeks prior
- Contraindications to PET-MRI including metal implants, claustrophobia, or inability to lie flat for 90 minutes
- Use of medications interfering with [18F] DPA-714 binding
- Current use of drugs of abuse or alcohol intake over 21 units per week in last 3 months
- Any other significant disease or disability that may risk participant or affect trial results
AI-Screening
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Trial Site Locations
Total: 1 location
1
John Van Geest Centre for Brain Repair
Cambridge, United Kingdom, CB2 0PY
Actively Recruiting
Research Team
T
Trial Coordinator
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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