In short
Currently, there is 1 ongoing clinical trial investigating apathy, a condition characterized by reduced interest and motivation. This trial is being conducted in France and focuses on understanding the brain systems involved in apathy following stroke using advanced imaging techniques.
Clinical trial locations
Study on Apathy in Stroke Patients Using Fluoroethoxybenzovesamicol F-18 and Fluorodopa (18F)
This clinical trial examines apathy in people who have had a stroke, focusing on understanding how two important brain systems contribute to this condition. The study uses special imaging substances to visualize brain activity and compare patients who experience apathy after stroke with those who do not.
Main inclusion criteria:
- Adults aged 18 to 74 years
- Rankin score of 2 or less, which measures disability after stroke on a scale from 0 (no symptoms) to 6
- Had a stroke 3 to 7 months before joining the study, with or without apathy (apathy 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
- Must provide written informed consent signed by both the participant and the investigator before any study procedures
Main exclusion criteria:
- Patients who have not had a stroke within the specified 3 to 7 month timeframe
- Patients outside the required age range
- Patients who do not meet the sex criteria for the study
- Patients who are not part of the vulnerable population selected for the study
Focus and goal:
The trial aims to explore the role of two brain systems: the cholinergic system, which is involved in memory and learning, and the dopaminergic system, which plays a role in mood and motivation. Participants undergo imaging procedures including MRI scans to measure brain activity and connectivity. The study compares the binding intensity of special tracers in the brain between stroke patients with apathy and those without apathy. Researchers also assess the clinical severity of apathy, functional connectivity, and blood flow in the brain. The study is expected to conclude by May 13, 2025, and aims to enhance understanding of how these brain systems contribute to apathy, potentially leading to better treatments in the future.
Investigational drugs:
The trial uses Fluoroethoxybenzovesamicol F-18 and Fluorodopa (18F), both administered as solutions for injection. These substances act as cholinergic and dopaminergic tracers, respectively. Cholinergic tracers help visualize and measure the activity of cholinergic pathways in the brain, while dopaminergic tracers allow researchers to observe the activity of dopaminergic pathways. These tracers bind to specific receptors or enzymes in their respective brain systems, enabling visualization through imaging techniques. They are classified as diagnostic agents used primarily in research and clinical trial settings rather than routine medical practice.
Summary
Currently, only one clinical trial is actively investigating apathy, and it is being conducted in France. This study takes a focused approach by examining the neurological basis of apathy following stroke, specifically looking at the cholinergic and dopaminergic systems in the brain. The trial uses advanced imaging techniques with specialized tracers to better understand how these brain systems function differently in patients with and without apathy after stroke. The research targets a specific population of stroke survivors at a particular recovery stage (3 to 7 months post-stroke), which may provide valuable insights into the development and mechanisms of post-stroke apathy. This singular trial highlights the need for more research in this area to develop effective treatments for patients experiencing apathy after stroke.
