Alzheimer's drug vs. brain exercises: which works better?
NCT ID NCT04661280
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 240 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2022
- Expected to finish
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Aug 2026
An estimate. End dates often move.
- Lead sponsor
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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
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50 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Cognitive Neurology Center
RECRUITINGParis, 75010, France
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Other studies related to the condition(s) this trial covers.
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