Donepezil Versus Non-drug Treatment in Alzheimer's Disease.

Recruiting now · Phase 3

Conditions studied: Alzheimer Disease, Early Onset

In brief

Donepezil, as well as the other symptomatic drugs of Alzheimer's disease, is not any more reimbursed by the French healthcare system, due to a controversy about its efficiency. French health authorities currently preconize a non-rug approach based on cognitive remediation or stimulation. The aim of this study is to compare the efficiency of the 2 approaches (non-drug versus donepezil) on the symptoms of Alzheimer's disease after 6 months of treatment.

Key facts

Study ID

NCT04661280

Run by

Assistance Publique - Hôpitaux de Paris

People needed

240

Starts

2022-02-10

Expected to finish

2026-08-01

Last updated by the study team

2026-02-18

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Cognitive Neurology Center — Paris, France (enrolling)

Full record on ClinicalTrials.gov

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