NCT04661280

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

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 50 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Alzheimer Disease, Early Onset

Interventions

Type	Name	Description
DRUG	Donepezil	Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.

Timeline

• Start date: 2022-02-10
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2020-12-10
• Last updated: 2026-02-18

Locations

1 site across 1 country: France