Donepezil Versus Non-drug Treatment in Alzheimer's Disease.
ConditionAlzheimer Disease, Early Onset
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age50+
SponsorAssistance Publique - Hôpitaux de Paris
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Donepezil
Treatment groups
240 Participants
are divided into 2 treatment groupsSponsors and collaborators
Assistance Publique - Hôpitaux de Paris
Lead sponsor
France Alzheimer
Collaborator
Source ClinicalTrials.gov