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.
Randomized multicentric open-label study, comparison of 2 therapeutic strategies. 2 arms: * Standard of care, non-drug approach: following the recommendations of the Alzheimer's disease care by the Frenchh Health Authority. The care is cognitive, psychic, functional or social and centered on the patient and his environment. This care is best carried out by the memory consultations participating in this study and having extensive experience in the care of Alzheimer patients. It is usually based in particular on the prescription of cognitive stimulation sessions by a speech therapist and a mobile Alzheimer specialist team at home for cognitive remediation sessions. * Donepezil group: Management similar to the previous arm plus addition of Donepezil 5 mg per os once a day for one month and then 10 mg per os once a day until the 6th month.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
240
Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.
Cognitive Neurology Center
Paris, France
RECRUITINGDifference of change in the MMSE score
Difference of change in the MMSE score between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). MMSE is measured at baseline, 6 weeks, 13 weeks, and 26 weeks.
Time frame: 26 weeks
Difference of change in the ADAS-Cog scale
Difference of change in the ADAS-Cog scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). ADAS-Cog scale = Alzheimer's Disease Assessment Scale-Cognitive Subscale, scored from 0 to 70
Time frame: 26 weeks
Difference of change in the CDR scale
Difference of change in the CDR scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). CDR scale = Clinical Dementia Rating, scored from 0 to 3
Time frame: 26 weeks
Difference of change in the ADL scale
Difference of change in the ADL scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). ADL scale = Autonomy scale on daily activities, scored from 0 to 78
Time frame: 26 weeks
Difference of change in the quality of life scale
Difference of change in the quality of life scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug).
Time frame: 26 weeks
Difference of change in the ZARIT scale
Difference of change in the ZARIT scale between baseline and 26 weeks in the 2 ams (donepezil versus non-drug). ZARIT scale = for assessing caregiver burden, scored from 0 to 88
Time frame: 26 weeks
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