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
Assistance Publique - Hôpitaux de Paris
240 participants
Feb 10, 2022
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
Inclusion Criteria8
- 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 Criteria22
- 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.
- Taking concomitant medications known to prolong the interval QTc
- 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.
- Antiarrhythmic class IA agents
- Antiarrhythmic class III agents
- other Antipsychotics such as phenothiazine, sertindole, pimozide, ziprasidone.
- some antiobiotics such as clarithromycine, erythromycine, levofloxacine, moxifloxacine.
- Participation in another interventional study.
Interventions
Donepezil 5 mg per day during one month, then 10 mg per day during 5 months.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04661280