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.
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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

DUMURGIER Julien, MD, PhD

+33140054313

julien.dumurgier@aphp.fr

CONTACT

PAQUET Claire, MD, PhD

claire.paquet@inserm.fr

CONTACT