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

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Dec 3, 2020

Keywords

ClinConnect Summary

This clinical trial is studying how effective the medication donepezil is compared to non-drug treatments for people with Alzheimer's disease, particularly those diagnosed at an early age. Donepezil has been a common treatment, but it is no longer covered by the French healthcare system due to questions about how well it works. In this study, researchers want to see which approach—donepezil or non-drug treatments like cognitive stimulation—helps improve Alzheimer's symptoms better after six months.

To participate in this trial, you need to be at least 50 years old and have a diagnosis of Alzheimer's disease. You should also be able to communicate in French and have someone at home who can help support your treatment. If you're interested, you would undergo evaluations to ensure you meet the study requirements, and if eligible, you can expect to receive either the medication or the non-drug treatment for six months while being monitored by the research team. This trial is currently recruiting participants, so it's a good opportunity to contribute to understanding better ways to manage Alzheimer's disease.

Gender

ALL

Eligibility criteria

• 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.