Donepezil Versus Non-drug Treatment in Alzheimer's Disease.
Recruiting
Phase 3
Interventional Study
Alzheimer Disease, Early Onset
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 50 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 240 (estimated)
- Sponsor
- Assistance Publique - Hôpitaux de Paris · Other
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About This Trial
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 symp…
Trial Locations
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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 phosphoryla…
Contacts