Status:
RECRUITING
Donepezil Versus Non-drug Treatment in Alzheimer's Disease.
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
France Alzheimer
Conditions:
Alzheimer Disease, Early Onset
Eligibility:
All Genders
50+ years
Phase:
PHASE3
Brief 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 authoriti...
Detailed Description
Randomized multicentric open-label study, comparison of 2 therapeutic strategies. 2 arms: * Standard of care, non-drug approach: following the recommendations of the Alzheimer's disease care by the ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04661280
Start Date
February 10 2022
End Date
August 1 2026
Last Update
December 30 2024
Active Locations (1)
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1
Cognitive Neurology Center
Paris, France, 75010