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

• Status: Not yet recruiting
• Trial end date: 2024-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Association France Alzheimer Et Maladies Apparentées; France Alzheimer
• Treatments: Donepezil

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.

• 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.

• Participation in another interventional study.