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

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT01404169
• Date of registration: 26/07/2011
• Primary sponsor: Eisai Co., Ltd.
• Public title: 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
• Scientific title: 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
• Date of first enrolment: September 2011
• Target sample size: 260
• Recruitment status: Recruiting
• URL: http://clinicaltrials.gov/show/NCT01404169
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

China

Contacts

• Name: Customer Joy Department. EJ

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

Key inclusion & 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 = 90 and = 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



Age minimum: 50 Years
Age maximum: 90 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Alzheimer's Type Dementia

Intervention(s)

Drug: E2020

Drug: Placebo

Primary Outcome(s)

The change in the total Severe Impairment Battery (SIB) score at Week 24 [Time Frame: 24 weeks]

Secondary Outcome(s)

Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24 [Time Frame: 24 weeks]

Secondary ID(s)

E2020-C086-339

Source(s) of Monetary Support

Please refer to primary and secondary sponsors