A Trial to Test the Use of Dapansutrile, an Anti-inflammatory Medication, in People With Parkinson's Disease

DAPA‐PD is a randomised double‐blind, placebo‐controlled phase II trial investigating thesafety and tolerability of dapansutrile (OLT1177), an NLRP3 inhibitor, in people withearly PD (Hoehn and Yahr stage ≤2, disease duration ≤5 years) who have evidence ofperipheral inflammation (high sensitivity C‐reactive protein [hsCRP] ≥1) as an adjunct todopaminergic therapies. 36 participants will be recruited at a single site and treatedwith either dapansutrile (1000mg twice daily) or placebo in a 2:1 ratio for a duration of6 months. This randomised placebo‐controlled phase of the trial will be followed by anoptional 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‐monthplacebo‐controlled phase.Safety data will be collected throughout both phases of the trial, through venous bloodsampling, electrocardiograms and clinical assessments. The trial will assess treatmentefficacy on peripheral and central inflammation, using biomarkers in blood and CSF, andtranslocator 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.