Actively Recruiting
Donepezil Versus Non-drug Treatment in Alzheimer's Disease.
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-18
240
Participants Needed
1
Research Sites
233 weeks
Total Duration
On this page
Sponsors
A
Assistance Publique - Hôpitaux de Paris
Lead Sponsor
F
France Alzheimer
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Donepezil Versus Non-drug Treatment in Alzheimer's Disease.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of Alzheimer's disease according to the IWG-2 criteria
- Age 50 years or older
- No legal protection measures like guardianship or curatorship
- Mini-Mental State Examination (MMSE) score of 10 or higher at inclusion
- Abnormal values for Aβ42 in cerebrospinal fluid (CSF) or Aβ40/Aβ42 ratio
- Abnormal values for phosphorylated Tau in CSF
- Presence of a family carer or person at home to ensure treatment compliance if MMSE score is below 20
- French native speaker
You will not qualify if you...
- Any other cause of dementia
- Previous use of symptomatic treatment for Alzheimer's disease
- Hypersensitivity to donepezil hydrochloride or its excipients
- Cardiological contraindications such as bradycardia, sinus disease, or conduction abnormalities
- Use of medications known to prolong QTc interval
- Risk or history of ulcer disease or use of non-steroidal anti-inflammatory drugs
- Risk of urinary retention
- History of epileptic disease or neuroleptic malignant syndrome
- History of asthma or obstructive bronchopulmonary disease
- Severe liver impairment
- Use of specific medications including CYP3A4 or CYP2D6 inhibitors, enzyme inducers, antiarrhythmic agents, certain antipsychotics, and some antibiotics
- Participation in another interventional study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cognitive Neurology Center
Paris, France, 75010
Actively Recruiting
Research Team
D
DUMURGIER Julien, MD, PhD
CONTACT
P
PAQUET Claire, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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