Clinical trial NCT01539031: 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
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Type Dementia
Keywords: Alzheimer Disease
Dementia
Delirium
Amnestic
Cognitive Disorders
Donepezil
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Mental Disorders
Cholinesterase Inhibitors
Enzy
Lead sponsor: Eisai Inc.
Sponsor class: INDUSTRY
First posted: 2012-02-27
Enrollment: 351
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The Severe Impairment Battery (SIB)
timeFrame: 24 weeks
measure: The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+)
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Anjo
country: Japan
state: Aichi
city: Obu
country: Japan
state: Aichi
city: Toyoake
country: Japan
state: Aichi
city: Chikushi
country: Japan
state: Fukuoka
city: Kitakyushu
country: Japan
state: Fukuoka
city: Fukuoka
country: Japan
state: Gunma
city: Miyoshi
country: Japan
state: Hiroshima
city: Otake
country: Japan
state: Hiroshima
city: Amagasaki
country: Japan
state: Hyogo
city: Himeji
country: Japan
state: Hyogo
city: Morioka
country: Japan
state: Iwate
city: Kida
country: Japan
state: Kagawa
city: Takamatsu
country: Japan
state: Kagawa
city: Kawasaki
country: Japan
state: Kanagawa
city: Sagamihara
country: Japan
state: Kanagawa
city: Yokohama
country: Japan
state: Kanagawa
city: Yokosuka
country: Japan
state: Kanagawa
city: Maizuru
country: Japan
state: Kyoto
city: Nagasaki
country: Japan
state: Kyushu
city: Sendai
country: Japan
state: Miyagi
city: Kitamorokata
country: Japan
state: Miyazaki
city: Ina
country: Japan
state: Nagano
city: Nagaoka
country: Japan
state: Niigata
city: Kurashiki
country: Japan
state: Okayama
city: Ibaraki
country: Japan
state: Osaka
city: Ikeda
country: Japan
state: Osaka
city: Sakai
country: Japan
state: Osaka
city: Sennan
country: Japan
state: Osaka
city: Takatsuki
country: Japan
state: Osaka
city: Age
country: Japan
state: Saitama
city: Iruma
country: Japan
state: Saitama
city: Kasukabe
country: Japan
state: Saitama
city: Tokorozawa
country: Japan
state: Saitama
city: Fuji
country: Japan
state: Shizuoka
city: Izunokuni
country: Japan
state: Shizuoka
city: Anan
country: Japan
state: Tokushima
city: Bunkyo-ku
country: Japan
state: Tokyo
city: Kodaira
country: Japan
state: Tokyo
city: Koto
country: Japan
state: Tokyo
city: Ota-ku
country: Japan
state: Tokyo
city: Setagaya
country: Japan
state: Tokyo
city: Suginami
country: Japan
state: Tokyo
city: Akita
country: Japan
city: Chiba
country: Japan
city: Fukuoka
country: Japan
city: Hiroshima
country: Japan
city: Iwate
country: Japan
city: Kagoshima
country: Japan
city: Kochi
country: Japan
city: Kyoto
country: Japan
city: Nara
country: Japan
city: Osaka
country: Japan
city: Saitama
country: Japan
city: Tokushima
country: Japan
Study officials:
affiliation: Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.
name: Naoki Kubota
role: STUDY_DIRECTOR
References: