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Alzheimer's drug vs. brain exercises: which works better?

NCT ID NCT04661280

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two approaches for treating newly diagnosed Alzheimer's disease: the drug donepezil versus a non-drug approach using cognitive stimulation or remediation. Researchers will measure changes in thinking and memory over 6 months in 240 participants aged 50 and older. The goal is to see which method better eases symptoms of early Alzheimer's.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 240 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

50 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of Alzheimer's disease according to the IWG-2 criteria. * Age ≥ 50 years. * Absence of legal protection measures (guardianship, curatorship). * MMSE score ≥ 10 at inclusion. * abnormal values for Aβ42 in the CSF or Aβ40 / Aβ42 ratio. * abnormal values for phosphorylated Tau in CSF * Presence of a family carer or a person at home who can ensure compliance with treatment if MMSE score \<20. * French native speaker. Exclusion Criteria: * Other cause of dementia. * Previous use of symptomatic treatment for Alzheimer's disease. * Hypersensitivity to donepezil hydrochloride or to any of the excipients listed in the SPC. * Cardiological contraindication after possible opinion of a cardiologist, at the initiative of the investigator, in particular bradycardia, sinus disease or other supra-ventricular conduction abnormalities such as sinoatrial or atrioventricular block. * Taking concomitant medications known to prolong the interval QTc * Patients at particular risk of ulcer, known ulcer disease or receiving concomitant treatment with non-steroidal anti-inflammatory drugs. * Patient at risk of urinary retention. * History of epileptic disease. * History of neuroleptic malignant syndrome. * History of asthma or obstructive bronchopulmonary disease. * Severe hepatic impairment. * Taking one of the following treatments: * CYP3A4 inhibitors, such as ketonazole. * 2D6 inhibitors, such as quinidine. * CYP3A4 inhibitors, such as itraconazole and erythromycin. * CYP2D6 inhibitors, such as fluoxetine. * Enzyme inducers such as rifampicin, phenytoin, carbamazepine. * Antiarrhythmic class IA agents * Antiarrhythmic class III agents * other Antipsychotics such as phenothiazine, sertindole, pimozide, ziprasidone. * some antiobiotics such as clarithromycine, erythromycine, levofloxacine, moxifloxacine. * Participation in another interventional study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cognitive Neurology Center

    RECRUITING

    Paris, 75010, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.