Donepezil Versus Non-drug Treatment in Alzheimer's Disease. (CHOLINE-2)

  • STATUS
    Recruiting
  • End date
    Aug 26, 2024
  • participants needed
    240
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 26 March 2022
mini-mental state examination
donepezil

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.

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.

Details
Condition Alzheimer Disease, Early Onset
Treatment donepezil
Clinical Study IdentifierNCT04661280
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on26 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of Alzheimer's disease according to the IWG-2 criteria
Age ≥ 50 years
Absence of legal protection measures (guardianship, curatorship)
MMSE score ≥ 10 at inclusion
abnormal values for Aβ42 in the CSF or Aβ40 / Aβ42 ratio
abnormal values for phosphorylated Tau in CSF
Presence of a family carer or a person at home who can ensure compliance with treatment if MMSE score <20\
French native speaker

Exclusion Criteria

Other cause of dementia
Previous use of symptomatic treatment for Alzheimer's disease
Hypersensitivity to donepezil hydrochloride or to any of the excipients listed in the SPC
Cardiological contraindication after possible opinion of a cardiologist, at the initiative of the investigator, in particular bradycardia, sinus disease or other supra-ventricular conduction abnormalities such as sinoatrial or atrioventricular block
Patients at particular risk of ulcer, known ulcer disease or receiving concomitant treatment with non-steroidal anti-inflammatory drugs
Patient at risk of urinary retention
History of epileptic disease
History of neuroleptic malignant syndrome
History of asthma or obstructive bronchopulmonary disease
Severe hepatic impairment
Taking one of the following treatments
CYP3A4 inhibitors, such as ketonazole
D6 inhibitors, such as quinidine
CYP3A4 inhibitors, such as itraconazole and erythromycin
CYP2D6 inhibitors, such as fluoxetine
Enzyme inducers such as rifampicin, phenytoin, carbamazepine
Participation in another interventional study
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