Not recruiting

Study on the Expression of the 5-HT4 Receptor in Patients with Mild to Moderate Parkinson's Disease Using [C11]-SB207145

Verified siteInvestigationalNo placebo

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What is this trial about?

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

This clinical trial is focused on studying Parkinson's disease, a condition that affects movement and can cause tremors, stiffness, and difficulty with balance and coordination. The study will use a special type of injection called [C11]-SB207145, which is a chemical substance designed to help researchers see how a specific part of the brain, known as the 5-HT4 receptor, is working in people with Parkinson's disease.

The purpose of the study is to compare the activity of the 5-HT4 receptor in patients with mild to moderate Parkinson's disease to that in healthy individuals of similar age. Participants will receive an injection of [C11]-SB207145, which will allow researchers to observe the brain's activity using imaging techniques. This will help in understanding how the disease affects the brain and may provide insights into new ways to treat or manage Parkinson's disease.

Throughout the study, participants will undergo various assessments to measure the expression of the tracer, which is the substance used to highlight the 5-HT4 receptor in the brain. The study will also explore how this expression relates to different symptoms of Parkinson's disease, such as motor and cognitive symptoms, as well as any genetic factors that might influence the disease. The study is expected to continue until 2025, providing valuable information that could contribute to future treatments for Parkinson's disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, an initial visit is scheduled. During this visit, eligibility is confirmed based on specific criteria such as age, disease progression, and cognitive assessment scores.
Written consent is required to participate in the study. This ensures understanding and agreement to the study's procedures and objectives.
Step 2
Baseline assessment
A comprehensive assessment is conducted to establish a baseline. This includes evaluating motor, non-motor, cognitive, and psycho-behavioral symptoms.
This assessment helps in understanding the current state of health and symptoms related to Parkinson's disease.
Step 3
Radiotracer administration
The study involves the administration of a special substance called a radiotracer, specifically [C11]-SB207145. This is given through an injection into a vein, known as an intravenous injection.
The radiotracer helps in visualizing certain receptors in the brain, which are important for the study.
Step 4
Imaging session
After the radiotracer is administered, an imaging session is conducted. This involves using a special machine to take pictures of the brain.
The images help in comparing the expression of specific receptors between individuals with Parkinson's disease and healthy individuals.
Step 5
Follow-up assessments
Follow-up assessments are conducted to monitor any changes in symptoms and to gather additional data.
These assessments may include similar evaluations as the baseline assessment, focusing on motor, non-motor, cognitive, and psycho-behavioral symptoms.
Step 6
Study completion
Upon completion of the study, a final visit is scheduled to discuss the overall experience and any findings related to the individual's participation.
Participants may receive information about the study's outcomes and any potential implications for their health.

Who can join the trial?

9 criteria

Have a clinically established or probable diagnosis of Parkinson's disease according to the criteria defined by the Movement Disorder Society at a Hoehn and Yahr stage ≤ 3 (for patients only). The Hoehn and Yahr scale is used to describe how severe Parkinson's disease is.
The disease should have been progressing for between 2 and 8 years (for patients only).
Have a MoCA score ≥ 20/30 (for patients only). MoCA stands for Montreal Cognitive Assessment, which is a test to check memory and thinking abilities.
Be aged between 50 and 85 years old.
If female, must be a postmenopausal woman. This means a woman who has stopped having menstrual periods for at least one year.
Be affiliated with a social security scheme or similar.
Have given written consent to participate in the study.
Have completed at least 6 years of schooling.
For healthy volunteers only: Have no history of neurological or psychiatric disease.

Who cannot join the trial?

10 criteria

Patients with any other serious medical condition that might interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of drug or alcohol abuse.
Patients who are unable to provide informed consent, which means they cannot understand the study and agree to participate.
Patients with severe mental health disorders that are not well controlled.
Patients who have had a major surgery within the last 3 months.
Patients with allergies to the study medication or its ingredients.
Patients who are currently taking medications that might interfere with the study.
Patients with a history of severe allergic reactions.

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Verified sites

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Verified
Hospices Civils de Lyon (HCL) - Hôpital des Charpennes
Villeurbanne, France

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Investigated drugs

The clinical trial focuses on the expression of the serotonergic 5-HT4 receptor in Parkinson's disease. However, the provided data does not include specific medications or therapies involved in the trial. Therefore, I cannot list any medications or therapies based on the given information.

(1-(111C)METHYLPIPERIDIN-4-YL)METHYL 5-AMINO-6-CHLORO-1,4-BENZODIOXINE-8-CARBOXYLATE

What is already known about the treatment

5-HT4 receptor modulator – This medication is being studied for its potential use in treating Parkinson's disease, a condition that affects movement and coordination. It is administered orally in the form of a pill. Currently, the medication is in the exploratory phase of clinical trials, where researchers are examining how it works in the body, particularly in people with mild to moderate Parkinson's disease. The main therapeutic goal is to understand its effect on the brain's serotonin system, specifically targeting the 5-HT4 receptor, which may help improve symptoms. This medication falls under the pharmacological class of serotonergic agents, which influence serotonin levels in the brain.

Investigated diseases

Parkinson's disease – Parkinson's disease is a progressive neurological disorder that primarily affects movement. It is characterized by tremors, stiffness, and difficulty with balance and coordination. As the disease progresses, individuals may experience slowness of movement and a decrease in facial expressions. Non-motor symptoms can also occur, including sleep disturbances, mood changes, and cognitive impairment. The disease is caused by the degeneration of dopamine-producing neurons in the brain. Over time, symptoms typically worsen, affecting daily activities and quality of life.