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

Launched by CAMBRIDGE UNIVERSITY HOSPITALS NHS FOUNDATION TRUST ·

Keywords

ClinConnect Summary

DAPA-PD is a Phase II clinical trial that tests whether dapansutrile, a medicine designed to calm inflammation in the body and brain, can be safe and potentially help people with early Parkinson’s disease. About 36 adults will take part at a single center in Cambridge, UK. Eligible participants are ages 50–80 with Parkinson’s for less than 5 years and with early disease (Hoehn and Yahr stage 2 or less), plus evidence of higher inflammation in the body (hsCRP > 1 mg/L). They can be someone who has not started Parkinson’s drugs or who has been on stable dopaminergic therapy for at least 3 months. You don’t have to be fluent in English, but you must meet the health criteria and agree to the study procedures. Exclusions include certain immune-related conditions or medicines, active infections, recent cancer, pregnancy potential, and the ability to undergo the required brain imaging and spinal taps.

Participants will be randomly assigned to receive either dapansutrile or a placebo for 6 months, in a double-blind setup (the patient and clinicians won’t know who gets the real drug). The dosing starts at 1000 mg per day for 4 weeks, then increases to 2000 mg per day. After 6 months, there is an optional 6-month open-label phase where everyone can take the active drug. Throughout the trial, people will have regular visits, blood tests, heart checks, a brain scan, and spinal fluid collection at specific times. The main goal is to assess safety and tolerability during the placebo-controlled period. They will also look at inflammation markers in blood and CSF, brain imaging to measure inflammation, and changes in motor and non-motor symptoms, cognition, mood, and quality of life. If you’re considering joining, contact the Cambridge trial team; the study is not yet recruiting as of the latest update, with site start anticipated in late 2025 and completion around early 2028.

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ALL

Eligibility criteria