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Study on Brain Inflammation in Schizophrenia Patients Using 18F-DPA-714

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 schizophrenia, a mental health condition that affects how a person thinks, feels, and behaves. The study will use a special imaging technique called Positron Emission Tomography (PET) to look at brain activity. The PET scan will use a substance called [18F]DPA-714, which is given as an injection. This substance helps to highlight certain areas of the brain during the scan.

The purpose of the study is to explore the relationship between brain inflammation and genetic factors in people with schizophrenia. The study will include both patients with schizophrenia and healthy volunteers. Participants will undergo PET scans to measure brain inflammation and may also have other types of scans, like MRI, to look at brain structure and connections. The study will also check for other health markers, such as cholesterol levels and blood sugar, to see how they relate to brain inflammation.

The study will take place over several years, with the goal of better understanding how genetic factors might influence brain inflammation in schizophrenia. This research could help in developing new ways to diagnose or treat the condition in the future.

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, health status, and genetic factors.
A detailed explanation of the study's objectives and procedures is provided. Informed consent is obtained, ensuring understanding and agreement to participate.
Step 2
Screening and baseline assessments
Screening involves a series of assessments to establish baseline health and mental status. This includes medical history review, physical examination, and laboratory tests.
Baseline imaging, such as magnetic resonance imaging (MRI), is conducted to assess brain structure and function.
Step 3
Administration of <b>18F-DPA-714</b>
The study involves the administration of a substance called 18F-DPA-714 through an intravenous injection. This is a tracer used in imaging to study brain activity.
The injection is performed under controlled conditions, and the dosage is carefully calculated based on individual factors.
Step 4
Positron emission tomography (PET) scan
Following the injection, a PET scan is conducted. This imaging technique allows for the visualization of brain activity and inflammation levels.
The scan is non-invasive and involves lying still in a scanner for a specified period.
Step 5
Follow-up assessments
After the PET scan, follow-up assessments are conducted to monitor health and any changes in condition.
These assessments may include additional imaging, blood tests, and questionnaires to evaluate mental and physical health.
Step 6
Final visit and study completion
A final visit is scheduled to conclude participation in the study. This includes a review of all collected data and a discussion of any findings relevant to individual health.
Participants are provided with information on how to access study results once available.

Who can join the trial?

8 criteria

Must be a male or female aged between 18 to 55 years.
If a patient, must have a diagnosis of schizophrenia according to DSM-5 criteria.
If a healthy volunteer, must be matched in age, sex, and genetic markers with patients.
Women of reproductive age must use effective contraception. This includes oral contraceptives, non-copper IUDs, diaphragms, contraceptive implants, or having undergone sterilization procedures.
Must be able to understand the research objectives and procedures.
Must be affiliated with or a beneficiary of a social security scheme.
Must have a specific genetic marker that allows for the study's imaging process (applies to 90% of subjects).
Must have signed a free and informed consent form.

Who cannot join the trial?

8 criteria

Patients who do not have a diagnosis of schizophrenia cannot participate.
Individuals who are not within the specified age range for the study cannot participate.
Participants who are unable to undergo a Positron Emission Tomography (PET) scan, which is a type of imaging test that helps doctors see how the organs and tissues inside your body are functioning, cannot participate.
Individuals who are pregnant or breastfeeding cannot participate.
Patients with any other medical condition that might interfere with the study results cannot participate.
Individuals who are currently participating in another clinical trial cannot participate.
Patients who have a history of substance abuse or dependency cannot participate.
Individuals who are unable to provide informed consent, which means they cannot understand the study and agree to participate, cannot participate.

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Verified sites

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Verified
French Alternative Energies And Atomic Energy Commision
Orsay, France
Verified
Hopital Henri Mondor - 1 rue Gustave Eiffel
Creteil, France

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Investigated drugs

[18F]DPA-714 is a special type of imaging agent used in a scan called Positron Emission Tomography, or PET for short. This agent helps doctors see certain activities in the brain, particularly related to inflammation. In this study, it is used to look at brain inflammation in people with schizophrenia. The goal is to understand how this inflammation might be connected to certain genetic factors in these patients. By using this imaging agent, doctors can get a clearer picture of what's happening in the brain, which might help in understanding and treating schizophrenia better.

N,N-Diethyl-2-(2-(4-(2[(18)F]-Fluoroethoxy)Phenyl)5,7Dimethylpyrazolo[1,5A]Pyrimidin-3-Yl)Acetamide

What is already known about the treatment

[18F]DPA-714 – This medication is administered through an injection and is used in a PET scan to study brain inflammation in patients with schizophrenia. Currently, it is being researched in clinical trials to understand its role in detecting neuro-inflammation related to schizophrenia. The main therapeutic indication is to help visualize and measure inflammation in the brain, which may be linked to genetic factors in schizophrenia. At the molecular level, [18F]DPA-714 binds to a specific protein on activated immune cells in the brain, allowing doctors to see areas of inflammation. It is classified as a radiopharmaceutical used in diagnostic imaging.

Investigated diseases

Schizophrenia – Schizophrenia is a chronic mental disorder that affects how a person thinks, feels, and behaves. It often manifests with symptoms such as hallucinations, delusions, and disorganized thinking. Individuals with schizophrenia may experience a distorted perception of reality, leading to difficulties in distinguishing between what is real and what is not. The progression of the disease can vary, with some experiencing episodes of severe symptoms followed by periods of improvement. Over time, cognitive functions such as memory and attention may decline. Social withdrawal and reduced motivation are also common as the disease progresses.