Donepezil Use Versus Non-drug Approach in Treatment of Newly Diagnosed Alzheimer's Disease : a Multicentric, Randomized, Open Study : the CHOLINE-2 Study

APHP201183

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.

2022-02-10

2026-08-01

2026-08-01

Recruiting

Early phase I

240

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.

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 240, 'type': 'ESTIMATED'}}

2023-11-30