Donepezil Versus Non-drug Treatment in Alzheimer's Disease.

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.

Interventions

• Donepezil · DRUG

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

Published eligibility criteria

Verbatim from the registry. Only the site can decide how these apply to a specific patient.

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.
* 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.
  * 2D6 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.

Sites (1)

• Cognitive Neurology Center, Paris, France · Recruiting