Phase 2 Parkinson's Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• People who have given written consent to take part in the trial.
• People aged between 50 and 80 years old (inclusive) at the time of the screening visit.
• People who speak English fluently.
• People who have been diagnosed with early Parkinson's disease (PD) based on recognised medical criteria for clinically established early Parkinson's disease.
• People whose Parkinson's disease was diagnosed less than 5 years before the screening visit.
• People whose Parkinson's disease is at an early stage, rated 2 or below on a standard scale used to measure how far the disease has progressed (called the Hoehn and Yahr scale).
• People who are either not yet taking any Parkinson's medication, or who have been on a stable dose of Parkinson's medication for at least 3 months before the screening visit (or who reach this stable dose between the screening and baseline visits).
• People who have had a blood test result showing a certain marker of inflammation (called hsCRP) at or above 1 mg/L, either at or within 2 years before the screening visit.
• People whose blood test results show that their blood, kidney, liver, thyroid, and calcium levels are within acceptable ranges as defined by the trial.

Who may not be able to join:

• People whose genetic test shows they are a "low affinity binder" for a specific protein marker used in the trial's brain scans (based on a gene variant called rs6971).
• People who have used immune-suppressing or immune-modifying medications (such as azathioprine, methotrexate, or similar drugs) within the 12 months before the screening visit, or between screening and the baseline visit.
• People who have ever used the medications rituximab or alemtuzumab at any point in the past.
• People who have taken oral corticosteroids (steroid tablets) for more than 2 weeks within the past 12 months, or any oral or injected steroids within the past 3 months before screening, or between screening and the baseline visit.
• People who regularly use anti-inflammatory pain medications (such as ibuprofen, naproxen, meloxicam, or aspirin at doses above 75 mg) on more than 2 days per week.
• People who have a significant inflammatory or autoimmune condition.
• People who have a chronic or hidden (latent) infection.
• People who have had a serious infection requiring intravenous or injected antibiotics or antifungals within 2 months before the screening visit, or between screening and the baseline visit.
• People who have an active skin, organ, or blood cancer at the time of screening or between screening and the baseline visit (with some exceptions for low-grade cancers under observation or hormonal treatment — confirm with trial site).
• People who are unable to swallow oral (tablet or capsule) medication.
• People who have been diagnosed with Parkinson's disease dementia according to recognised medical criteria.
• People who have a known gene mutation known to cause Parkinson's disease.
• People who test positive for HIV, hepatitis B, hepatitis C, or syphilis.
• People who have chronic liver disease.
• People who have another medical or mental health condition that the trial doctor believes could interfere with the trial or pose a safety risk.
• Women who are able to become pregnant — female participants must be either surgically sterile or post-menopausal (defined as having had no periods for at least 12 months without another medical explanation).
• Male participants who are not surgically sterile and who do not agree to use effective contraception during treatment and for 6 months after the last dose of the trial medication.
• People who have a known allergy or sensitivity to the trial drug (dapansutrile) or any of its ingredients.
• People who have taken part in another interventional clinical trial or used an investigational medical device within 12 weeks before the screening visit, or who are currently enrolled in another interventional trial (participation in observational studies may be acceptable — confirm with trial site).
• People who cannot have a combined PET and MRI brain scan, for example due to metal implants in the body, claustrophobia, or being unable to lie still for 90 minutes.
• People who are taking certain medications (such as some benzodiazepines) that could interfere with the brain scan used in this trial, unless those medications can safely be paused before the scan (confirm with trial site).
• People who currently use recreational drugs, or who drink more than 21 units of alcohol per week on average over the past 3 months.
• People who have any other significant health condition, disability, or test result that the lead investigator believes could put them at risk or affect the trial results.

Important: Always verify eligibility with the trial site directly before applying.