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

This is an interventional treatment trial for Alzheimer Disease, Early Onset focused on measuring Alzheimer Disease, Donepezil Read More

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.
  • 2D6 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.