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Recruiting Phase 3

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

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About this study

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.

Condition
Alzheimer Disease, Early Onset
Tested
Donepezil
Sponsor
Assistance Publique - Hôpitaux de Paris

Who can join

Age
50 years and older
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 10

  • Minimum age: 50 years
  • Study condition: Alzheimer Disease, Early Onset
  • 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 22

  • 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.

Where

1 site, 1 recruiting

Cognitive Neurology Center

Paris, France

Recruiting

Contact

Potential match only. Final eligibility is determined by the study team.