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Clinical Trial Summary

The primary objectives are to confirm that donepezil hydrochloride has superior efficacy compared with placebo in improving cognitive function, as measured by Alzheimer's Disease Assessment Scale-Cognitive subscale (ADAS-cog), and to demonstrate that donepezil hydrochloride has superior efficacy compared with placebo in improving global function, as measured by Clinician's Interview-Based Impression of Change-plus Caregiver Input (CIBIC-plus), in patients with dementia associated with cerebrovascular disease (VaD).


Clinical Trial Description

This is a multi-center, randomized, double-blind, placebo-controlled, parallel-group study with an open-label extension. The study consists of 3 phases; screening phase (1 to 4 weeks), double-blind phase (24 weeks), and Open-label extension phase (24 weeks). Participants, who have completed the double-blind phase and want to continue the study participation, can be enrolled in the 24-week open-label extension phase. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02660983
Study type Interventional
Source Eisai Inc.
Contact
Status Completed
Phase Phase 4
Start date August 5, 2013
Completion date December 21, 2018

See also
  Status Clinical Trial Phase
Completed NCT00188812 - Safety of Donepezil in Patients With Dementia Associated With Cerebrovascular Disease Phase 3