RecruitingPhase 3NCT04661280

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


Sponsor

Assistance Publique - Hôpitaux de Paris

Enrollment

240 participants

Start Date

Feb 10, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This French trial compares donepezil (a standard medication for Alzheimer's disease) against non-drug approaches (such as cognitive stimulation or other non-pharmacological interventions) in people with confirmed Alzheimer's disease, to see which approach better preserves thinking and quality of life. **You may be eligible if...** - You are 50 or older with a confirmed diagnosis of Alzheimer's disease - Your diagnosis is supported by specific biomarkers in spinal fluid (abnormal amyloid or tau levels) - Your cognitive score (MMSE) is 10 or higher - You are a native French speaker - If your MMSE is below 20, a family caregiver or household member is available to help with treatment compliance **You may NOT be eligible if...** - You have a different cause of dementia - You have already used Alzheimer's medication (like donepezil, memantine, rivastigmine) - You have heart rhythm problems (like bradycardia or heart block) or are on medications that can affect the QT interval - You have asthma, obstructive lung disease, epilepsy, or severe liver problems - You are currently participating in another interventional clinical trial Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGDonepezil

Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.


Locations(1)

Cognitive Neurology Center

Paris, France

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NCT04661280


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