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
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
1 other identifier
interventional
351
1 country
54
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Mar 2012
Typical duration for phase_3
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2012
CompletedFirst Posted
Study publicly available on registry
February 27, 2012
CompletedStudy Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedJune 18, 2023
September 1, 2015
2.8 years
February 21, 2012
June 16, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The Severe Impairment Battery (SIB)
SIB: change from Baseline to Week 24 in the total SIB score - Last Observation Carried Forward (LOCF)
24 weeks
The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)
CIBIC+: overall change score at Week 24 - Last Observation Carried Forward (LOCF)
24 weeks
Study Arms (2)
10 mg group
EXPERIMENTAL23 mg group
ACTIVE COMPARATORInterventions
Subjects in the Group-10 mg: Week 1 to 4: Once daily donepezil 10 mg and placebo matching donepezil 5 mg, Week 5 to 28: Once daily donepezil 10 mg and placebo matching donepezil 23 mg, Week 29 to 32: Once daily donepezil 5 mg, 10 mg and placebo matching donepezil 23 mg, Week 33 to 52: Once daily donepezil 23 mg
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (54)
Unknown Facility
Anjo, Aichi-ken, Japan
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Ōbu, Aichi-ken, Japan
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Toyoake, Aichi-ken, Japan
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Chikushi, Fukuoka, Japan
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Kitakyushu, Fukuoka, Japan
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Fukuoka, Gunma, Japan
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Miyoshi, Hiroshima, Japan
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Ōtake, Hiroshima, Japan
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Amagasaki, Hyōgo, Japan
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Himeji, Hyōgo, Japan
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Morioka, Iwate, Japan
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Numakunai, Iwate, Japan
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Kida, Kagawa-ken, Japan
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Takamatsu, Kagawa-ken, Japan
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Kawasaki, Kanagawa, Japan
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Sagamihara, Kanagawa, Japan
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Yokohama, Kanagawa, Japan
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Yokosuka, Kanagawa, Japan
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Maizuru, Kyoto, Japan
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Nagasaki, Kyushu, Japan
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Sendai, Miyagi, Japan
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Kitamorokata, Miyazaki, Japan
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Ina, Nagano, Japan
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Nagaoka, Niigata, Japan
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Kurashiki, Okayama-ken, Japan
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Ibaraki, Osaka, Japan
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Ikeda, Osaka, Japan
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Sakai, Osaka, Japan
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Sennan, Osaka, Japan
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Takatsuki, Osaka, Japan
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Age, Saitama, Japan
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Iruma, Saitama, Japan
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Kasukabe, Saitama, Japan
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Tokorozawa, Saitama, Japan
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Fuji, Shizuoka, Japan
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Izunokuni, Shizuoka, Japan
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Anan, Tokushima, Japan
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Bunkyo-ku, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Koto, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya City, Tokyo, Japan
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Suginami, Tokyo, Japan
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Akita, Japan
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Chiba, Japan
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Fukuoka, Japan
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Hiroshima, Japan
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Kagoshima, Japan
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Kochi, Japan
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Kyoto, Japan
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Nara, Japan
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Osaka, Japan
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Saitama, Japan
Unknown Facility
Tokushima, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Naoki Kubota
Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 21, 2012
First Posted
February 27, 2012
Study Start
March 1, 2012
Primary Completion
January 1, 2015
Study Completion
March 1, 2015
Last Updated
June 18, 2023
Record last verified: 2015-09