DAPA-PD: a trial to test the use of dapansutrile, an anti-inflammatory medication, in people with Parkinson’s disease
The DAPA-PD study is investigating a new medication called dapansutrile, which aims to reduce inflammation in the brain. We believe brain inflammation might play a role in Parkinson's disease. The main goal is to find out if this medicine can help slow down the disease's progression. This is a Phase II study, meaning we're testing the drug's effectiveness and safety at an earlier stage. It involves people aged 50 to 80 who have early Parkinson's. Participants will either receive the study drug or a dummy drug for 26 weeks, with an optional extra 26 weeks where everyone receives the study drug. The trial is taking place in Cambridge, UK, and will involve several visits.
At a glance
What is this study about?
Parkinson's disease happens when special nerve cells in an area of the brain, called the substantia nigra, slowly die off. These cells produce a chemical called dopamine, which is essential for controlling how we move. When there isn't enough dopamine, it leads to many of the symptoms of Parkinson's. Scientists now think that swelling or inflammation in the brain might be one of the reasons these nerve cells are damaged and lost.
This study, called DAPA-PD, wants to see if a medication called dapansutrile can help. Dapansutrile is designed to calm down inflammation. We want to find out if taking this medication can reduce inflammation in the brains of people with Parkinson's and if it has any effect on how the disease changes over time.
Dapansutrile is a new drug and is not yet approved for use for any condition in any country. However, it has been tested in other clinical trials for different health problems like heart failure and COVID-19, and so far, it has been shown to be safe for people to use.
Key takeaways
- The study explores if an anti-inflammatory drug, dapansutrile, can help Parkinson's.
- It aims to see if the drug reduces brain inflammation and slows disease progression.
- Participation involves regular visits to Cambridge for up to a year.
- You may receive the study drug or a placebo during the first phase.
- There are potential benefits for future Parkinson's patients, but no guaranteed direct benefit.
- It involves detailed assessments, including blood tests, MRI, PET scans, and some lumbar punctures.
Who may be eligible?
To join this study, you need to be between 50 and 80 years old, including your 50th and 80th birthdays. You also need to have been recently diagnosed with Parkinson's disease. This means you should have had Parkinson's for less than five years and be in the early stages, where your symptoms are not too severe yet.
It's important that your overall health is good, especially your organ functions like kidneys, liver, and blood counts. We'll check these with some blood tests. You also need to be able to speak English fluently.
There are also some reasons why you might not be able to join. For example, if you've recently taken certain medications that affect your immune system, or if you have specific genetic markers that mean the drug might not work for you as intended. If you have metal in your body that can't go near magnets, you might not be able to have some of the scans.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you between 50 and 80 years old?
- Have you been diagnosed with Parkinson's disease for less than 5 years?
- Are your Parkinson's symptoms still in the early stages?
- Are you generally in good health, with normal-range organ function?
- Do you speak English fluently?
- Have you avoided certain immune-affecting medications recently?
What does participation involve?
If you decide to take part, the study has two main parts. For the first 26 weeks, you'll be randomly given either dapansutrile or a dummy drug (placebo). Two out of three participants will get the actual drug, and one out of three will get the dummy. Neither you nor your study doctor will know which one you're taking, though the doctor can find out if absolutely necessary. During this time, you'll need to visit the study clinic in Cambridge 10 times.
After these 26 weeks, you'll have the option to continue into a second part of the study for another 26 weeks. In this part, everyone who agrees to continue will receive dapansutrile. You'll have 7 more visits to the clinic during this phase. If you choose not to go into the second part, you'll have one final visit. The study will likely involve various assessments, blood tests, and scans, including PET and MRI scans, as well as a lumbar puncture (spinal tap) for some tests.
Potential risks and benefits
Locations (1)
- AddenbrookesApproximateCambridge, England
Common questions
What is dapansutrile?
Dapansutrile is a new medication that aims to reduce inflammation in the body. In this study, we're trying to see if it can help reduce brain inflammation in people with Parkinson's disease.
Is dapansutrile already approved for use?
No, dapansutrile is still an experimental drug and is not yet approved for use for any health condition or in any country.
Where is the study happening?
The study is currently being run from Cambridge in the UK. All in-person visits will be at this location.
How long will I be involved in the study?
The first part of the study lasts 26 weeks. If you choose to, you can participate in an optional second part for another 26 weeks, making the total study involvement around a year.
Will I know if I'm getting the real drug or a dummy drug?
No, during the first 26 weeks, neither you nor your study doctor will know whether you are receiving dapansutrile or a placebo (dummy drug).
How to find out more
Caroline Williams-Gray
Always speak to your GP or specialist before deciding to take part in a study.
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