A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease.

Trial Profile

A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease.

Completed
Phase of Trial: Phase III

Latest Information Update: 13 Dec 2017

At a glance

  • Drugs Donepezil (Primary)
  • Indications Alzheimer's disease
  • Focus Registrational; Therapeutic Use
  • Sponsors Eisai Co Ltd
  • Most Recent Events

    • 13 Dec 2017 According to an Eisai media release, based on the results from this trial, Aricept (donepezil hydrochloride) has been approved for the additional indication of severe Alzheimer's disease in China.
    • 30 Sep 2014 Top-line results published in an Eisai media release. Based on the results of this trial, an application will be made to Chinese regulatory authorities to extend the indications for donepezil to include severe Alzheimer's disease.
    • 30 Sep 2014 Primary endpoint has been met (Change in total Severe Impairment Battery score at Week 24; significant superiority of donepezil vs placebo), according to an Eisai media release.
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