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

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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 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.

The research process

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

  1. Step 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. Step 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. Step 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. Step 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. Step 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. Step 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 trial?

6 criteria

  • 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 trial?

4 criteria

  • 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.
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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.

What is already known about the treatment

  • Cholinergic Tracers

    These are substances used in medical imaging to study the cholinergic system in the brain. They are typically administered intravenously and are used in research settings to understand brain function and disorders. Currently, cholinergic tracers are primarily used in clinical trials and research rather than routine medical practice. They help in identifying changes in the brain's cholinergic pathways, which can be linked to conditions like apathy. At the molecular level, these tracers bind to specific receptors or enzymes in the cholinergic system, allowing visualization through imaging techniques. They are classified as diagnostic agents in pharmacology.

  • Dopaminergic Tracers

    These are compounds used to visualize the dopaminergic system in the brain, often administered through injection for imaging purposes. They are mainly used in research and clinical trials to explore neurological conditions and are not yet widely used in standard medical treatments. Dopaminergic tracers are crucial for studying the brain's dopamine pathways, which can be altered in conditions such as apathy. They work by binding to dopamine receptors or transporters, enabling their detection through imaging technologies. These tracers are categorized as diagnostic tools in the field of pharmacology.

Investigated diseases

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 detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-518721-15-00Estimated enrolment30 patientsSponsorCentre Hospitalier Universitaire De Bordeaux

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