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Study of serotonin system changes in early Parkinson's disease using [11C]DASB and [11C]SB207145 PET imaging in people with SNCA gene mutations

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on Parkinson's disease, specifically examining its early stage known as the prodromal phase. The research uses two special imaging substances: 11C-DASB and 11C-SB207145, which are given as solutions for injection into the bloodstream. These substances help create detailed images of the brain using a special scanning technique called PET (Positron Emission Tomography).

The purpose of this study is to investigate changes in the brain's serotonin system during the early stages of Parkinson's disease. The research specifically looks at people who carry a particular genetic change in the SNCA gene, which is associated with Parkinson's disease. The study will compare these individuals with healthy people who do not have this genetic change.

During the study, participants will receive the imaging substances through an intravenous injection. They will undergo brain scanning procedures that include MRI (Magnetic Resonance Imaging) and other specialized imaging tests. The study will examine how these substances bind to specific areas in the brain and what this reveals about the early stages of the disease.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial imaging procedures
You will undergo two types of brain imaging: PET scans using special tracers called [11C]DASB and [11C]SB207145, which will be given through an intravenous injection
A DaTSCAN and MRI (magnetic resonance imaging) of your brain will be performed
If you are taking certain medications (neuroleptics, metoclopramide, alpha methyldopa, methylphenidate, reserpine, or amphetamine derivatives), you will need to temporarily stop taking them for a period determined by your doctor before the DaTSCAN
Step 2
Clinical assessments
Your motor symptoms (movement-related) and non-motor symptoms will be evaluated using specific assessment scales
The doctor will check for signs of Parkinson's disease, including slowness of movement, muscle stiffness, and tremors
Step 3
Biological samples
Blood samples will be collected for analysis
A sample of cerebrospinal fluid (fluid surrounding the brain and spinal cord) may be collected for biomarker testing
Step 4
Study duration
The study is scheduled to run from September 2025 to March 2029
Your individual participation timeline will be determined by the completion of all required procedures and assessments

Who can join the trial?

8 criteria

Age between 18 and 80 years old at the time of signing consent
Must be enrolled in the French social security system
For patients with Parkinson's disease: must have slowness of movement AND at least ONE of these symptoms: - muscle stiffness - tremor while resting
Must either have: - a confirmed genetic change in the alpha-synuclein gene (SNCA), or - no changes in this gene, or - be a close family member (parent, sibling, or child) of someone with the genetic change
Must be physically able to complete study tests, including brain imaging
Must provide informed consent (either personally or through a legal representative)
If taking certain medications (such as antipsychotics, anti-nausea drugs, or stimulants), must be able to temporarily stop taking them before brain scanning
For family members of gene carriers and healthy participants: must not have symptoms of Parkinson's disease

Who cannot join the trial?

12 criteria

Presence of any neurological disorders other than Parkinson's disease or prodromal Parkinson's disease
History of brain surgery or severe head trauma
Current or recent (within 6 months) use of medications that could affect brain serotonin system
Pregnancy or breastfeeding in female participants
Known allergic reactions to substances similar to the study medications
Presence of any metal implants or devices that would interfere with brain imaging (such as pacemakers, cochlear implants, or metal clips)
Claustrophobia (fear of confined spaces) that would prevent brain imaging procedures
Significant psychiatric conditions that could interfere with study procedures
Inability to lie still for extended periods during imaging procedures
Current participation in other clinical trials or research studies
Any condition that, in the opinion of the study doctor, would make participation unsafe
Inability to provide informed consent

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University Hospitals Pitie Salpetriere Charles Foix
Paris, France

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Investigated drugs

[11C]DASB
is a radioactive tracer used in brain imaging (PET scans) to study the serotonin system. It helps researchers see how serotonin, a chemical messenger in the brain, is functioning. This tracer is particularly useful in studying changes that might occur in the early stages of Parkinson's disease.
[11C]SB207145
is another radioactive tracer used in PET scanning that also helps visualize the serotonin system in the brain, but targets a different type of serotonin receptor. This tracer allows researchers to examine different aspects of serotonin function and how it might be affected in people who carry genetic mutations associated with Parkinson's disease.

What is already known about the treatment

[11C]DASB
A radioactive tracer used in Positron Emission Tomography (PET) imaging that specifically binds to serotonin transporters in the brain. This diagnostic agent is administered intravenously during PET scanning to visualize and measure serotonin system function, particularly in research studying the early stages of Parkinson's disease. The compound helps researchers understand changes in the brain's serotonin system before motor symptoms of Parkinson's disease appear.
[11C]SB207145
A specialized radioactive imaging agent used in PET scanning that targets serotonin 5-HT4 receptors in the brain. This diagnostic tracer is given through intravenous injection during brain imaging procedures to evaluate changes in the serotonin system, specifically in research focusing on the early detection of Parkinson's disease. The compound allows scientists to visualize and measure specific aspects of brain serotonin function in living subjects.

Investigated diseases

Parkinson's disease
A progressive neurological disorder that affects movement and motor control. It develops when nerve cells in the brain that produce dopamine begin to die or become impaired. The condition typically starts gradually with mild symptoms that worsen over time. Common signs include tremors, particularly in the hands, slowed movement (bradykinesia), stiff muscles, impaired posture and balance, and changes in speech patterns.
Prodromal Parkinson's disease
The early phase of Parkinson's disease that occurs before classic motor symptoms become apparent. During this stage, individuals may experience subtle changes such as loss of smell, sleep disorders, constipation, and mild cognitive changes. This phase can last several years before the development of more recognizable movement-related symptoms. The changes occur due to early degeneration of certain brain cells and the presence of abnormal protein accumulation.