Skip to content
Clinical Trials – home

Rare diseases

Investigational molecules

Locations

Our offerNewsroom

Recruiting

Study on Donepezil Versus Non-drug Treatment for Patients with Alzheimer's Disease

Verified siteRegistered drugNo placebo
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Alzheimer's disease, a condition that affects memory and thinking skills. The study will compare the effects of a medication called donepezil with non-drug treatments that are typically recommended in France for managing Alzheimer's disease. Donepezil is a medication that comes in the form of a film-coated tablet and is taken orally. The purpose of the study is to evaluate how well donepezil works in improving cognitive function over a period of six months compared to usual non-drug management.

Participants in the study will be divided into two groups. One group will receive donepezil daily, while the other group will follow the usual non-drug treatment plan. The study will last for six months, during which the cognitive abilities of participants will be assessed to see if there is any improvement. The study will also look at other aspects such as quality of life and daily living activities to understand the overall impact of the treatments.

Throughout the study, participants will be monitored to ensure their safety and well-being. The results will help determine if adding donepezil to the usual care pathway provides any additional benefits for people with Alzheimer's disease. This information could be valuable in guiding future treatment options for managing this condition.

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

    Joining the study

    Upon joining the study, you will be informed about the purpose and procedures involved. You will be asked to provide consent to participate.

    You will undergo an initial assessment to confirm your eligibility, which includes verifying your diagnosis of Alzheimer's disease and other criteria.

  2. Step 2

    Initial assessment

    A series of tests will be conducted to evaluate your cognitive abilities. This includes the MMSE (Mini-Mental State Examination) to assess your mental state.

    Additional tests may include checking specific proteins in your cerebrospinal fluid, which are related to Alzheimer's disease.

  3. Step 3

    Treatment allocation

    You will be assigned to one of two groups: one group will receive the medication donepezil, and the other will follow a non-drug treatment plan.

    The allocation is random, and neither you nor the study team will choose which group you are in.

  4. Step 4

    Medication administration

    If you are in the medication group, you will take donepezil orally every day. The dosage and specific instructions will be provided by the study team.

    The treatment will last for a period of six months.

  5. Step 5

    Regular follow-up visits

    You will attend regular follow-up visits to monitor your progress. These visits will include cognitive tests and discussions about your health and any side effects.

    The study team will ensure that you are following the treatment plan and address any concerns you may have.

  6. Step 6

    Final assessment

    At the end of the six-month period, a final assessment will be conducted to evaluate the effects of the treatment.

    This will include repeating the cognitive tests and discussing your overall experience during the trial.

Who can join the trial?

8 criteria

  • Must have a diagnosis of Alzheimer's disease according to specific medical guidelines from 2014.
  • Must be covered by social security.
  • Must be 50 years old or older.
  • Must not be under any legal protection measures like guardianship or curatorship.
  • Must have a Mini-Mental State Examination (MMSE) score of 10 or higher. The MMSE is a test that helps assess memory and thinking skills.
  • Must have specific levels of proteins in the cerebrospinal fluid (CSF), which is the fluid around the brain and spine. These proteins are called Aβ42 and phosphorylated tau, and they must be abnormal according to local standards.
  • If the MMSE score is less than 20, there must be a family member or someone at home who can help ensure the treatment is followed.
  • Must have a sufficient understanding of the French language to take certain tests that assess thinking and memory.

Who cannot join the trial?

5 criteria

  • Patients who are not diagnosed with Alzheimer's disease cannot participate.
  • Patients who are not within the age range specified for the study cannot participate.
  • Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.
  • Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
  • Patients who have any other medical condition that might interfere with the study cannot participate.
Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Recruiting
Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Donepezil is a medication used in the treatment of Alzheimer's disease. It works by increasing the levels of a certain natural substance in the brain, which helps improve memory, awareness, and the ability to function. In this clinical trial, donepezil is being tested to see how well it can improve cognitive abilities over a period of six months compared to non-drug treatments.

What is already known about the treatment

Donepezil – Donepezil is a medication taken orally, usually in the form of a tablet, and is used to help manage symptoms of Alzheimer's disease. It is currently well-established in medical practice and literature as a treatment option for improving cognitive function in individuals with Alzheimer's. The main therapeutic use of donepezil is to enhance memory and thinking abilities in people with this condition. At the molecular level, donepezil works by increasing the levels of a chemical in the brain called acetylcholine, which helps nerve cells communicate better. It belongs to a class of drugs known as cholinesterase inhibitors.

Investigated diseases

Alzheimer's disease – Alzheimer's disease is a progressive neurological disorder that leads to the degeneration of brain cells, causing memory loss and cognitive decline. It typically begins with mild memory lapses and confusion, which gradually worsen over time. As the disease progresses, individuals may experience difficulties with language, disorientation, mood swings, and behavioral changes. In advanced stages, individuals may lose the ability to carry out daily activities and require full-time care. The exact cause of Alzheimer's disease is not fully understood, but it involves a combination of genetic, environmental, and lifestyle factors. The progression of the disease varies from person to person, but it generally follows a slow and steady decline in cognitive and functional abilities.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515038-34-00Protocol codeAPHP201183Estimated enrolment240 patientsSponsorAssistance Publique Hopitaux De Paris

sourced from the EU Clinical Trials Register and site verification

Want to learn more about this trial or check if you can participate?

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.