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Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

Information source: Eisai Inc.
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Alzheimer's Type Dementia

Intervention: E2020 (Drug); E2020 (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Eisai Co., Ltd.

Official(s) and/or principal investigator(s):
Naoki Kubota, Study Director, Affiliation: Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.


The purpose of this study is to compare 23 mg donepezil sustained release to the currently marketed formulation of 10 mg donepezil immediate release in patients with severe Alzheimer's disease.

Clinical Details

Official title: Randomized, Multicenter, Double-blind, Double-dummy, Parallel-Group Study With an Open-label Extension Phase to Compare the Efficacy and Safety of Donepezil Hydrochloride 23 mg Treatment With Continuation of Donepezil Hydrochloride 10 mg Treatment in Japanese Subjects With Severe Alzheimer's Disease

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome:

The Severe Impairment Battery (SIB)

The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)


Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.


Inclusion Criteria

- Diagnosis: diagnostic evidence of probable Alzheimer's disease (AD) consistent with

Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV-TR) 290. 00 or 290. 10

- Mini Mental State Examination (MMSE) less than or equal to 12 and greater than or

equal to1 inclusive, at Screening

- SIB less than or equal to 90 and greater than or equal to10 at both Screening and


- No evidence of focal disease to account for dementia on any cranial image (magnetic

resonance imaging [MRI] or computed tomography [CT]).

- Subject age range: male and female subjects greater than or equal to 50 years of age


- Outpatients (patients in nursing homes are eligible)

- The subject must have a caregiver who will provide informed consent separately for

his/her own participation in the study, who will have regular contact with the subject.

- Stable donepezil dose of 10 mg, taken as a single, daily dose for greater than or

equal to 3 months prior to the Screening visit

- Subjects who can swallow hole tablets, as tablets should not be broken or crushed

- Comorbid medical conditions must be clinically stable prior to Screening unless

otherwise specified.

- Written informed consent will be obtained from the subject (if possible) or from the

subject's legal guardian or other representative (according to Japanese regulations as appropriate) prior to beginning screening activities. Exclusion Criteria

- Subjects with a known history of disorders that affect cognition or the ability to

assess cognition but are distinguishable from AD

- Subjects with dementia complicated by other organic disease or AD with delirium

- Known hypersensitivity to donepezil or piperidine derivatives, or to any of the

excipients in the study drug formulation

- Patients who are expected to live in a nursing home within 24 weeks after

randomization (eligible if temporary)

- Use of any prohibited prior or concomitant medications. Memantine will be allowed if

taken at prescribed doses that are less than or equal to 20 mg/day, provided that the dose has been stable for at least 6 months prior to Screening.

Locations and Contacts

Akita, Japan

Chiba, Japan

Fukuoka, Japan

Hiroshima, Japan

Iwate, Japan

Kagoshima, Japan

Kochi, Japan

Kyoto, Japan

Nara, Japan

Osaka, Japan

Saitama, Japan

Tokushima, Japan

Anjo, Aichi, Japan

Obu, Aichi, Japan

Toyoake, Aichi, Japan

Chikushi, Fukuoka, Japan

Kitakyushu, Fukuoka, Japan

Fukuoka, Gunma, Japan

Miyoshi, Hiroshima, Japan

Otake, Hiroshima, Japan

Amagasaki, Hyogo, Japan

Himeji, Hyogo, Japan

Morioka, Iwate, Japan

Kida, Kagawa, Japan

Takamatsu, Kagawa, Japan

Kawasaki, Kanagawa, Japan

Sagamihara, Kanagawa, Japan

Yokohama, Kanagawa, Japan

Yokosuka, Kanagawa, Japan

Maizuru, Kyoto, Japan

Nagasaki, Kyushu, Japan

Sendai, Miyagi, Japan

Kitamorokata, Miyazaki, Japan

Ina, Nagano, Japan

Nagaoka, Niigata, Japan

Kurashiki, Okayama, Japan

Ibaraki, Osaka, Japan

Ikeda, Osaka, Japan

Sakai, Osaka, Japan

Sennan, Osaka, Japan

Takatsuki, Osaka, Japan

Age, Saitama, Japan

Iruma, Saitama, Japan

Kasukabe, Saitama, Japan

Tokorozawa, Saitama, Japan

Fuji, Shizuoka, Japan

Izunokuni, Shizuoka, Japan

Anan, Tokushima, Japan

Bunkyo-ku, Tokyo, Japan

Kodaira, Tokyo, Japan

Koto, Tokyo, Japan

Ota-ku, Tokyo, Japan

Setagaya, Tokyo, Japan

Suginami, Tokyo, Japan

Additional Information

Starting date: March 2012
Last updated: March 31, 2015

Page last updated: August 20, 2015

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