NCT01404169

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: Eisai Limited · Industry
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease.

Conditions

• Alzheimer's Type Dementia

Interventions

Type	Name	Description
DRUG	E2020	In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.
DRUG	Placebo	Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-07-01
• Completion: 2014-09-01
• First posted: 2011-07-27
• Last updated: 2017-03-08

Locations

32 sites across 1 country: China