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

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What is this study about?

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.

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 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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Fondation A De Rothschild Paris France
Hopital Beaujon Clichy France
Hovcwet Lhezipl Bhfhvb Paris France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Recruiting
10.02.2022

Trial locations

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.

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 ID:
2024-515038-34-00
Protocol code:
APHP201183
NCT ID:
NCT04661280
Trial Phase:
Therapeutic confirmatory (Phase III)

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