AuthorisedPhase II and Phase III (Integrated)Interventional

Assessment of the impairment of the serotoninergic system during the prodromal phase of Parkinson’s disease in SNCA mutation carriers by PET using [11C]DASB and [11C]SB207145 : SerIAL-PD

This research aims to understand how the brain's serotonin system changes before Parkinson's disease fully develops, particularly in people with a specific genetic change (SNCA mutation). Researchers will use two types of special brain scans, called PET scans, with two different 'tracers' ([11C]DASB and [11C]SB207145). These tracers help them see how parts of the serotonin system are working. By comparing people with the genetic change to those without, the study hopes to identify early indicators of Parkinson's. This could lead to a better understanding of the disease's earliest stages and potentially new ways to diagnose or treat it sooner.

At a glance

Status

Authorised

Phase

Phase II and Phase III (Integrated)

Sponsor

Institut National De La Sante Et De La Recherche Medicale

Enrolment target

Start

29 Aug 2025

Parkinson's disease Prodromal phase of Parkinson's disease

What is this study about?

Imagine your brain is like a complex messaging system, and serotonin is one of the important messengers. This study is trying to understand how this serotonin messaging system might start to change in people who are in the very early stages of Parkinson's disease, even before they show clear symptoms. We know that some people have a genetic change called an SNCA mutation, which puts them at a higher risk of developing Parkinson's.

To see these subtle changes, researchers will use special brain scans, called PET scans. During these scans, they'll use very small amounts of special 'tracers' (think of them as tiny glowing tags) that attach to specific parts of the serotonin system. By looking at how these tracers show up on the scans, the researchers can tell if the serotonin system is working differently. The main goal is to compare the brain scans of people with the SNCA genetic change to those without, to see if there are unique patterns in the serotonin system.

The findings from this study are really important because if we can identify changes in the brain in the very early stages of Parkinson's, it could open doors for earlier diagnosis and, eventually, new treatments that could slow down or even stop the progression of the disease. This is a crucial step towards better managing Parkinson's.

Key takeaways

This study looks for early brain changes in people at risk of Parkinson's.
It focuses on the brain's serotonin messaging system.
Special PET scans will be used to see these changes.
Comparing people with and without a specific genetic change (SNCA mutation) is key.
The goal is to find early signs to help with future diagnosis and treatments.

Who may be eligible?

To take part in this study, you need to be at least 18 years old – there's no upper age limit. The study is open to both men and women.

Researchers are particularly interested in people who either have a specific genetic change (called an SNCA mutation) but don't yet have symptoms of Parkinson's, or people who don't have this genetic change and also don't have Parkinson's symptoms.

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 at least 18 years old?
Are you male or female?
Do you have an SNCA genetic mutation but no Parkinson's symptoms?
OR do you NOT have an SNCA genetic mutation and no Parkinson's symptoms?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll undergo several assessments. This will primarily involve having special brain scans called PET scans. You might have two different types of these scans, each using a small amount of a 'tracer' substance. You may also have other tests like a DaTSCAN, an MRI scan (which uses magnets to take detailed pictures of your brain), and researchers might check for certain markers in your blood and spinal fluid. You will also complete questionnaires or tests that assess your movement and other symptoms. The total duration of your participation in the study is not specified but will involve multiple visits for these tests and scans.

Potential risks and benefits

Potential benefits of taking part include contributing valuable information that could help better understand and treat Parkinson's disease in the future. You will also receive detailed information about your own health from the scans and tests. Potential risks involve the procedures themselves, such as slight discomfort from injections for the tracers, and exposure to a very small amount of radiation from the PET scans, which is generally considered safe. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
France

Common questions

What is Parkinson's disease?

Parkinson's disease is a condition that affects the brain, causing problems with movement like shaking, stiffness, and difficulty balancing. It can also cause other symptoms not related to movement.

What is the 'prodromal phase'?

This is a very early stage of a disease, where people might have some subtle signs or symptoms, but not enough to be clearly diagnosed with the full condition yet.

What is a PET scan?

A PET scan is a type of imaging test that allows doctors to see how your organs and tissues are working. For this study, it helps us see activity in parts of your brain.

What is an SNCA mutation?

An SNCA mutation is a specific change in a gene that has been linked to an increased risk of developing Parkinson's disease.

Will I get my test results?

The study aims to provide detailed information about your health from the scans and tests you undertake.