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.
Summary
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+)
Eligibility
Minimum age: 50 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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
Baseline
- 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
inclusive
- 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
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