Effect of PXS-4728A on Microglia Activation in Participants With Isolated Rapid Eye Movement Sleep Behaviour Disorder

To join this study, you must be between 50 and 80 years old. You need to have been diagnosed with Isolated REM Sleep Behavior Disorder (iRBD) by a doctor. The doctors will also check for some specific signs that suggest a higher risk of developing other brain conditions, such as problems with your sense of smell, colour vision, or some mild movement difficulties.

You'll also need to have certain blood test results within a healthy range, especially for your liver. If you are a woman who could become pregnant, you'll need to have a negative pregnancy test and agree to use two reliable forms of birth control throughout the study and for 90 days afterward. Men whose partners could become pregnant will also need to use similar birth control methods.

Finally, the study will involve a special brain scan (called a PET scan) which needs to show certain signals in your brain. You must also be able to understand the study and agree to take part by signing a consent form.

If you decide to take part, the first step is a 'Screening period' lasting up to two weeks. During this time, doctors will check if you meet all the requirements for the study. This will likely involve health checks, blood tests, and medical history questions.

If you are eligible, you'll be officially enrolled. You will need to visit the study clinic on 'Day 1'. On this day, you'll be given either the active study medicine (PXS-4728A) or the placebo. You'll also have initial health assessments. The exact number of visits after Day 1 isn't specified, but the study focuses on a single dose. Details about any follow-up visits or the total length of time you'd be involved will be fully explained by the study team. An independent group called a Data Safety Monitoring Committee will keep an eye on the study to make sure it's safe for everyone involved.