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

Eisai

Status and phase

Completed

Phase 3

Conditions

Alzheimer's Type Dementia

Treatments

Drug: E2020

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT01404169

E2020-C086-339

Details and patient eligibility

About

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.

Enrollment

260 patients

Sex

All

Ages

50 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
Subject age range: male and female subjects 50 to 90 years of age, inclusive
Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
MMSE 1 to 12 inclusive, at both Screening and Baseline
SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.

Exclusion Criteria

Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
Evidence of focal disease to account for dementia on any cranial image MRI or CT.
Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
Illiteracy prior to AD
Subjects who are unwilling or unable to fulfill the requirements of the study
Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening
Subjects with a poor response (tolerability) to prior exposure to donepezil