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 study about?

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.

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

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

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

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 Study?

  • 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 Study?

  • 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

Where you can join this trial?

Verified and Recommended Sites

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Other Sites

Site Name City Country Status
Ctcnnf &voreal iofuibae df vlsmup Bron France
Uhimhcxkoa Hxocvfegn Pdjah Sjflhlpfkkf Cxbdddm Folu Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
01.09.2025

Trial locations

[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.

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.

Trial ID:
2024-516610-38-00
Protocol code:
C24-41
Trial Phase:
Therapeutic use (Phase IV)

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