NCT04661280 · Phase 3 · RECRUITING
Donepezil Versus Non-drug Treatment in Alzheimer's Disease.
This trial compares donepezil, a long-used symptom-relief pill, against a non-drug approach such as cognitive stimulation. It measures how Alzheimer's symptoms look after 6 months. It is a Phase 3 trial, a larger comparison of how well approaches work, not a test of a new drug. It enrolls people already diagnosed with Alzheimer's.
Eligibility criteria
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.
The sponsor's own eligibility wording, lightly reformatted. The study team makes the final eligibility decision — worth discussing with your doctor.
Eligibility criteria as of 2026-02-18