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Study on the Effects of Donepezil on Cognitive and Motor Functions in Elderly Patients with Neurological Disorders

Verified siteRegistered drugNo 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 the effects of a medication called donepezil hydrochloride on certain brain functions in older adults. The study involves healthy volunteers aged 50 and above. Donepezil hydrochloride is a medication commonly used to increase levels of a chemical in the brain called acetylcholine, which is important for memory and learning. The trial will compare the effects of a single 5 mg dose of donepezil hydrochloride with a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to understand how donepezil hydrochloride affects cognitive and motor functions, which are related to thinking and movement, in older adults. Participants will be asked to perform tasks that require both thinking and physical movement, known as dual-task activities. The study will measure how well participants perform these tasks after taking either the medication or the placebo. Additionally, the study will use a technique called MRI (Magnetic Resonance Imaging) to observe brain activity during these tasks.

The trial will take place over a short period, with participants attending two visits. During these visits, they will complete various tests to assess their cognitive and motor skills. The results will help researchers understand the potential benefits of donepezil hydrochloride in improving brain function in older adults. This study is important for exploring new ways to support healthy aging and cognitive health.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit and consent

    Upon joining the study, you will attend an initial visit. During this visit, you will be asked to provide written informed consent. This means you agree to participate in the study after understanding its nature, significance, and procedures.

    You will be assessed to ensure you meet the study's inclusion criteria, such as being a healthy volunteer aged 50 years or older, right-handed, with a body mass index (BMI) between 18 and 32 kg/m², and suitable for MRI scans.

  2. Step 2

    First administration and testing

    You will receive a single dose of either donepezil hydrochloride (5 mg) or a placebo. This will be administered orally in the form of a film-coated tablet.

    After taking the medication, you will participate in tasks designed to measure your cognitive and motor functions. These tasks will assess your reaction time and motor skills, such as pedaling speed.

    Your brain activity will be monitored using functional magnetic resonance imaging (fMRI) during these tasks.

  3. Step 3

    Second administration and testing

    At a later visit, you will again receive a single dose of either donepezil hydrochloride (5 mg) or a placebo, depending on what you received during the first administration.

    You will repeat the same cognitive and motor tasks as in the first visit. Your performance will be measured to compare the effects of the medication versus the placebo.

    Your brain activity will be monitored again using fMRI during these tasks.

  4. Step 4

    Completion of trial

    After completing the second set of tasks, your participation in the trial will conclude.

    The study aims to compare the effects of increased acetylcholine levels on cognitive and motor functions in elderly volunteers.

Who can join the trial?

7 criteria

  • Must be a healthy volunteer.
  • Can be male or female and must be 50 years or older.
  • Must be right-handed.
  • Body Mass Index (BMI) must be between 18 and 32 kg/m2. BMI is a measure of body fat based on height and weight.
  • Must be suitable for MRI. MRI is a type of scan that uses magnetic fields and radio waves to create detailed images of the inside of the body.
  • Must provide written informed consent according to international guidelines and local laws. This means you agree to participate after being fully informed about the study.
  • Must have the capacity to understand the nature, significance, and consequences of the trial and the trial-related procedures and be able to comply with them.

Who cannot join the trial?

3 criteria

  • People with **neurological disorders** cannot participate. Neurological disorders are conditions that affect the brain, spinal cord, or nerves.
  • Individuals who are not within the specified age range for the study cannot participate. The study is for elderly participants.
  • Participants who are part of a vulnerable population are not eligible. Vulnerable populations include groups like children, pregnant women, or those unable to give consent.
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Investigated drugs

Donepezil is a medication used in this trial to help increase the levels of a chemical in the brain called acetylcholine. Acetylcholine is important for memory and thinking. By increasing its levels, donepezil may help improve cognitive functions, which include things like memory, attention, and the ability to perform tasks that require thinking. In this study, donepezil is being tested to see if it can help elderly people perform better on tasks that require both thinking and moving at the same time, like walking while talking or doing other activities.

What is already known about the treatment

Donepezil – Donepezil is taken orally in the form of a tablet and is used to help improve cognitive and motor functions in elderly individuals. It is currently being studied in clinical trials to assess its impact on brain activity and dual-task performance, which involves doing two tasks at once. The main use of donepezil is to treat neurological disorders, particularly those affecting memory and thinking. It works by increasing the levels of a chemical in the brain called acetylcholine, which helps nerve cells communicate better. Donepezil belongs to a group of drugs known as cholinesterase inhibitors, which prevent the breakdown of acetylcholine, thereby enhancing its effects.

Investigated diseases

Neurological Disorders – Neurological disorders encompass a wide range of conditions that affect the nervous system, including the brain, spinal cord, and nerves. These disorders can lead to a variety of symptoms such as muscle weakness, coordination problems, and changes in sensation. As they progress, individuals may experience difficulties with movement, balance, and cognitive functions. The progression can vary greatly depending on the specific disorder and individual factors. Some neurological disorders may lead to gradual decline in physical and mental abilities. The impact on daily life can increase over time, affecting independence and quality of life.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-512172-35-00Protocol code2023-UOL-MG-004-01Estimated enrolment50 patientsSponsorCarl Von Ossietzky Universitaet Oldenburg

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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