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Study on the Effect of Clozapine on Immune Response in Patients with Parkinson's Disease

Verified siteRegistered drugNo 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 the effects of the medication Clozapine in patients with Parkinson's disease. Parkinson's disease is a condition that affects movement, causing symptoms like tremors, stiffness, and difficulty with balance and coordination. Clozapine is a medication that is often used to treat certain mental health symptoms, such as psychosis, which can occur in Parkinson's disease.

The purpose of this study is to evaluate how Clozapine affects the immune system, specifically by looking at changes in a type of protein in the blood called IgG, which is part of the body's defense system. Participants in the study will take Clozapine for a period of up to 12 months. During this time, researchers will monitor various health aspects, including changes in weight, the number of infections, and the use of antibiotics. They will also assess how well patients tolerate Clozapine and any side effects they may experience.

Throughout the study, participants will have regular visits where their motor skills, quality of life, mood, and cognitive abilities will be evaluated using different clinical scales. Blood tests will be conducted to measure levels of IgG and other immune-related proteins, as well as to check the levels of Clozapine in the blood. The study aims to provide a better understanding of how Clozapine impacts the immune system and overall health in people with Parkinson's 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
Initiation of treatment
Begin taking clozapine orally as prescribed. This medication is used to manage psychotic symptoms associated with Parkinson's disease.
The main goal is to evaluate changes in the immune system, specifically the serum IgG level, over a period of 6 months.
Step 2
Baseline assessment
Undergo initial assessments, including blood tests to measure serum IgG, IgA, IgM levels, and other parameters such as CBC and CRP.
Complete evaluations of motor status, quality of life, and cognitive functions using clinical scales like MDS-UPDRS, PDQ39, and MoCA.
Step 3
Follow-up at 6 months
Attend a follow-up visit at 6 months (M6) to repeat blood tests and assessments.
Monitor changes in weight, number of infections, and use of antibiotics.
Evaluate tolerance and any adverse effects of clozapine treatment.
Assess variations in motor status, quality of life, and other health indicators.
Step 4
Final assessment at 12 months
Attend the final assessment at 12 months (M12) to complete the same evaluations as at M6.
This includes blood tests, monitoring of infections, antibiotic use, and assessment of treatment tolerance.
Conclude with a comprehensive evaluation of health status and any changes observed during the trial.

Who can join the trial?

4 criteria

Patient must be **18 years or older**.
Patient must have **Parkinson's disease**.
Patient must have **psychotic symptoms** that require starting treatment with **Clozapine**. Psychotic symptoms can include things like seeing or hearing things that aren't there or having unusual thoughts.
Both **men and women** can participate.

Who cannot join the trial?

5 criteria

Patients with **Parkinson's disease** cannot participate. This is a condition that affects movement and can cause tremors and stiffness.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. This means the study is looking for people with specific characteristics or conditions.
Both **male** and **female** patients can participate, but if you do not identify as either, you may not be eligible.
Patients who are considered part of a **vulnerable population** cannot participate. This usually means people who might need extra protection or care.

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Verified sites

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Verified
Centre Hospitalier Universitaire Amiens Picardie
Amiens, France

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Investigated drugs

Clozapine is a medication used in this trial to assess its effect on the immune system of patients with Parkinson's disease. The study aims to evaluate changes in the immune response, specifically looking at the levels of certain antibodies in the blood, after six months of treatment with this medication.

Clozapine

What is already known about the treatment

Clozapine – Clozapine is administered orally in tablet form and is primarily used to treat schizophrenia, but it is also being studied for its effects in Parkinson's disease. It is currently under investigation in clinical trials to assess its impact on immune function in patients with Parkinson's disease. The main therapeutic indication for Clozapine is to manage symptoms of schizophrenia, particularly in patients who do not respond to other treatments. At the molecular level, Clozapine works by blocking dopamine receptors in the brain, which helps to reduce symptoms such as hallucinations and delusions. It is classified as an atypical antipsychotic medication.

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. Over time, symptoms can extend beyond motor issues, potentially affecting mood, sleep, and cognitive abilities. The exact cause of Parkinson's disease is not fully understood, but it involves the degeneration of dopamine-producing neurons in the brain. The progression of symptoms varies from person to person, and the rate of progression can differ significantly.