Study on Apathy in Stroke Patients Using Fluoroethoxybenzovesamicol F-18 and Fluorodopa (18F)

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What is this study about?

This clinical trial is focused on studying apathy, a condition often characterized by a lack of interest or motivation, which can occur after a stroke. The study aims to explore the role of two important systems in the brain: the cholinergic system, which is involved in memory and learning, and the dopaminergic system, which plays a role in mood and motivation. The trial will use two special substances, Fluoroethoxybenzovesamicol F-18 and Fluorodopa (18F), both administered as a solution for injection, to help visualize these systems in the brain.

The purpose of the study is to compare the brain activity related to these systems in two groups of people who have had a stroke: those who experience apathy and those who do not. Participants will be observed 3 to 7 months after their stroke. The study will involve using imaging techniques to measure how these substances bind in the brain, which can provide insights into the functioning of the cholinergic and dopaminergic systems.

Throughout the study, participants will receive injections of the substances and undergo imaging procedures, such as MRI (Magnetic Resonance Imaging), to assess brain activity and connectivity. The study will also look at other factors like the severity of apathy and blood flow in the brain. This research aims to enhance understanding of how these brain systems contribute to apathy, potentially leading to better treatments in the future.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying age, medical history, and current health status.

Eligibility criteria include being of legal age and younger than 75 years, having a Rankin score of 2 or less, and being 3 to 7 months post-stroke with or without apathy.

2 consent process

Participants are required to provide free, informed, and written consent. This must be signed by both the participant and the investigator before any study-related procedures begin.

3 medication administration

Participants receive two types of injections: Fluoroethoxybenzovesamicol F-18 and Dopacis 90 MBq/mL. These are solutions for injection used to study brain activity.

The purpose of these injections is to compare the binding intensity of cholinergic and dopaminergic tracers in the brain.

4 imaging procedures

Participants undergo imaging procedures, including MRI scans, to measure brain activity and connectivity.

These scans help assess the clinical severity of apathy, functional connectivity, and cerebral blood flow.

5 data collection and analysis

Data collected from the imaging procedures are analyzed to compare the integrity of cholinergic and dopaminergic pathways in participants with and without apathy.

The primary focus is on the binding intensities of the tracers, while secondary endpoints include clinical severity of apathy and other brain imaging parameters.

6 follow-up and conclusion

The study is expected to conclude by May 13, 2025. Participants may be contacted for follow-up assessments to monitor any long-term effects or changes.

Who Can Join the Study?

Must be a patient who is at least 18 years old but younger than 75 years old.
Must have a Rankin score of 2 or less. The Rankin score is a way to measure how much help someone needs after a stroke. It ranges from 0 (no symptoms) to 6 (dead).
Must have had a stroke 3 to 7 months ago, with or without apathy. Apathy means a lack of interest or emotion. It is measured using the AI scale, where a score greater than 2 indicates apathy.
Must be affiliated with or a beneficiary of a social security scheme.
Female participants and female partners of male participants must use highly effective birth control methods, such as an intra-uterine device (IUD), hormonal contraceptives, or sterilization.
Must provide free, informed, and written consent, signed by both the participant and the investigator, before any study-related examinations.

Who Cannot Join the Study?

Patients who have not had a stroke in the last 3 to 7 months.
Patients who are not within the specified age range for the study.
Patients who do not match the required sex criteria for the study.
Patients who are not part of the vulnerable population selected for the study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
France	Recruiting	13.04.2021

Trial locations

Investigated drugs:

Cholinergic Tracers are used in this trial to study the cholinergic system in the brain. These tracers help visualize and measure the activity of cholinergic pathways, which are involved in transmitting signals in the brain. By comparing the binding intensity of these tracers, researchers can assess the integrity of the cholinergic system in patients who have experienced a stroke.

Dopaminergic Tracers are utilized to examine the dopaminergic system in the brain. These tracers allow researchers to observe and quantify the activity of dopaminergic pathways, which play a crucial role in mood, motivation, and movement. The trial aims to compare the binding intensity of these tracers to understand how the dopaminergic system is functioning in patients with and without apathy after a stroke.

Investigated diseases:

Apathy

Apathy – Apathy is a condition characterized by a lack of interest, enthusiasm, or concern. It often manifests as a diminished motivation to engage in activities or respond to stimuli. Individuals with apathy may exhibit reduced emotional expression and a lack of initiative. This condition can occur in various contexts, including after a stroke, where it may affect recovery and rehabilitation. Apathy can impact daily functioning and social interactions, leading to challenges in personal and professional life. Understanding the underlying neurological pathways involved in apathy is crucial for comprehending its progression and effects.

Trial ID:

2024-518721-15-00

NCT ID:

NCT03998852

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Apathy in Stroke Patients Using Fluoroethoxybenzovesamicol F-18 and Fluorodopa (18F)

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