AuthorisedTherapeutic use (Phase IV)Interventional

Assessment of clozapine-related immunodeficiency effect in Parkinson's disease patients (CLOZIDPD)

This study is investigating if a medicine called clozapine, used to help people with Parkinson's disease, affects their immune system. The immune system is your body's natural defence against infections. Researchers want to see if clozapine changes the levels of certain proteins in the blood, called IgG, which are important for fighting off illness. They will measure these levels before someone starts taking clozapine and then again after six months of treatment. The study will also look at other things like changes in weight, how many infections people get, and any side effects from the medication. This will help doctors understand better how clozapine works and if it has any impact on a person's ability to stay healthy.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Centre Hospitalier Universitaire Amiens Picardie

Enrolment target

Start

23 Aug 2024

Parkinson's disease

What is this study about?

This research is looking into a medicine called clozapine, which is sometimes used to help people with Parkinson's disease. Doctors want to understand if this medicine affects the body's immune system. Your immune system is really important because it protects you from infections and illnesses.

The main thing researchers will be checking is how clozapine affects certain levels in your blood, specifically something called IgG. These IgG levels are a way to measure how well your immune system is working. They will take a blood test before you start taking clozapine and then again after you've been on the medicine for six months. This will help them see if there's any change.

Besides the immune system, the study will also look at other important aspects of your health. This includes things like your weight, whether you get more infections, and if you need to take antibiotics. They will also check if the medicine causes any side effects, how it affects your movement, quality of life, mood, thinking, and any other symptoms related to Parkinson's disease. The aim is to get a full picture of how clozapine affects people with Parkinson's, building on existing knowledge about this medicine.

Key takeaways

This study looks at how clozapine affects the immune system in Parkinson's patients.
It checks specific blood markers (IgG) before and 6 months after starting clozapine.
The study also monitors overall health, infections, and side effects over a year.
It aims to provide more information on how clozapine impacts health in wider ways.
Participation involves several visits for blood tests and health assessments.

Who may be eligible?

This study is open to both men and women. You must be at least 18 years old to take part; there's no upper age limit mentioned.

To be considered for this study, you need to have Parkinson's disease and your doctor must be planning to start you on clozapine treatment. This study is specifically for understanding the effects of clozapine in people who are new to this particular medication.

More detailed information about who can and cannot join, such as specific health conditions or other medicines you might be taking, would be discussed with you by the study team if you express interest.

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.

Do I have Parkinson's disease?
Am I at least 18 years old?
Has my doctor decided to start me on clozapine treatment soon?
Am I able to attend study visits over a year?
Am I happy for blood samples to be taken?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it will involve several visits over a period of about a year. You will have assessments at the very beginning (Day 0), after 6 months (Month 6), and again after 12 months (Month 12).

During these visits, you will have blood tests taken to check various levels, including those related to your immune system. You might also be weighed, and the study team will ask you about any infections you've had or if you've used antibiotics. You'll also complete questionnaires and possibly do some tasks to assess your movement, mood, thinking, and overall well-being. The study focuses on how clozapine affects you, so you will be taking clozapine as part of your regular medical treatment, as prescribed by your doctor. The study itself does not involve taking extra medication, but observes how your body reacts to the clozapine you would already be starting. You will be monitored for any side effects from the clozapine during these visits.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. A potential benefit of this study is that it helps doctors understand more about how clozapine affects people with Parkinson's disease, especially regarding the immune system. This could lead to better care for others in the future. However, there are potential risks, such as those that come with blood tests, like mild bruising or discomfort. Clozapine itself has known side effects, and the study will monitor these carefully. You will be fully informed of all known risks associated with clozapine before you start. Remember, this is a research study, and there's no guarantee of direct personal benefit. You are free 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 clozapine?

Clozapine is a medicine that doctors sometimes prescribe to help treat certain symptoms in people with Parkinson's disease, particularly when other treatments haven't worked well.

What is the 'immune system'?

Your immune system is your body's natural defense against infections, viruses, and illnesses. It helps you stay healthy by fighting off germs.

Why are you checking blood levels?

Researchers will check specific blood levels, like IgG, to see if clozapine affects how well your immune system is working. These levels help doctors understand your body's ability to fight off infections.

Is this a new medicine?

No, clozapine is an existing medicine. This study is about understanding more about its effects on the immune system in people with Parkinson's disease who are starting the treatment.

How long will I be in the study?

If you take part, you'll be involved for about a year, with assessments at the very beginning, after 6 months, and after 12 months.