NCT02660983

A Study of Donepezil Hydrochloride in Patients With Dementia Associated With Cerebrovascular Disease

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Donepezil Hydrochloride (E2020) in Patients With Dementia Associated With Cerebrovascular Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 302 (actual)
• Sponsor: Eisai Co., Ltd. · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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).

Detailed 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.

Conditions

• Dementia Associated With Cerebrovascular Disease

Interventions

Type	Name	Description
DRUG	Donepezil hydrochloride
DRUG	Donepezil matching placebo
DRUG	Donepezil hydrochloride

Timeline

• Start date: 2013-08-05
• Primary completion: 2018-07-13
• Completion: 2018-12-21
• First posted: 2016-01-21
• Last updated: 2020-01-10
• Results posted: 2019-10-04

Locations

31 sites across 1 country: South Korea