Actively Recruiting
Donepezil Use Versus Non-drug Approach in Treatment of Newly Diagnosed Alzheimer's Disease: a Multicentric, Randomized, Open Study: the CHOLINE-2 Study
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2026-02-18
240
Participants Needed
1
Research Sites
N/A
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
Researchers are comparing two treatment approaches for people with Alzheimer's disease: a non-drug method based on cognitive stimulation and remediation, and a drug treatment using Donepezil. This study aims to see how well these approaches improve symptoms after six months, especially since Donepezil is no longer reimbursed by the French healthcare system. The trial is randomized, open-label, and multicentric, focusing on patients newly diagnosed with Alzheimer's disease. Participants are assigned to one of two groups. The first group receives standard care involving cognitive, psychological, functional, and social support, including cognitive stimulation sessions with speech therapists and mobile specialist teams at home. The second group receives the same non-drug approach plus Donepezil tablets, starting at 5 mg daily for one month and increasing to 10 mg daily for the remaining five months. During the 26-week study, participants will undergo various assessments such as the Mini-Mental State Examination (MMSE), Alzheimer's Disease Assessment Scale-Cognitive (ADAS-Cog), Clinical Dementia Rating (CDR), Activities of Daily Living (ADL), quality of life, and caregiver burden (ZARIT scale). Researchers will monitor changes in these measures to evaluate treatment effects. The trial includes safety monitoring and follow-up over the full six months.
CONDITIONS
Brief 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 such as guardianship or curatorship
- MMSE score equal to or greater than 10 at inclusion
- Abnormal Aβ42 levels or Aβ40/Aβ42 ratio in cerebrospinal fluid
- Abnormal phosphorylated Tau levels in cerebrospinal fluid
- Presence of a family carer or someone at home to ensure treatment compliance if MMSE score is less than 20
- French native speaker
You will not qualify if you...
- Dementia caused by conditions other than Alzheimer's disease
- 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
- High risk or history of ulcers or use of NSAIDs
- Risk of urinary retention
- History of epilepsy or neuroleptic malignant syndrome
- History of asthma or obstructive bronchopulmonary disease
- Severe liver impairment
- Use of certain interacting medications including CYP3A4 and CYP2D6 inhibitors, enzyme inducers, antiarrhythmic agents, antipsychotics, and some antibiotics
- Participation in another interventional study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 26 weeks
Participants receive either a non-drug cognitive remediation approach or cognitive remediation combined with Donepezil medication.
Regular visits throughout the 26 weeks as per study protocol
Trial Site Locations
Total: 1 location
1
Cognitive Neurology Center
Paris, France, 75010
Actively Recruiting
Research Team
D
DUMURGIER Julien, MD, PhD
P
PAQUET Claire, MD, PhD
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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