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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

NCT01404169 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2017-03-08

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Eisai Limited

    lead INDUSTRY

Principal Investigators

  • Naoki Kubota · Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2014-07-31
Completion
2014-09-30

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01404169 on ClinicalTrials.gov