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

This study is currently recruiting participants.
Verified February 2014 by Eisai Inc.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01539031
First received: February 21, 2012
Last updated: February 13, 2014
Last verified: February 2014

February 21, 2012
February 13, 2014
March 2012
March 2015   (final data collection date for primary outcome measure)
  • The Severe Impairment Battery (SIB) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    SIB: change from Baseline to Week 24 in the total SIB score - Last Observation Carried Forward (LOCF)
  • The Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC+) [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    CIBIC+: overall change score at Week 24- Last Observation Carried Forward (LOCF)
Same as current
Complete list of historical versions of study NCT01539031 on ClinicalTrials.gov Archive Site
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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
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alzheimer's Type Dementia
  • Drug: E2020

    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

  • Drug: E2020

    Subjects in the Group-23 mg:

    Week 1 to 4: Once daily donepezil 5 mg and 10 mg, Week 5 to 28: Once daily donepezil 23 mg and placebo matching donepezil 10 mg, Week 29 to 32: Once daily donepezil 23 mg, and placebo matching donepezil 5 mg and 10 mg, Week 33 to 52: Once daily donepezil 23 mg

  • Experimental: 10 mg group
    Intervention: Drug: E2020
  • Active Comparator: 23 mg group
    Intervention: Drug: E2020
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
330
June 2015
March 2015   (final data collection date for primary outcome measure)

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.
Both
50 Years and older
No
Contact: Customer Joy Department. EJ ML_CLNCL@hhc.eisai.co.jp
Japan
 
NCT01539031
E2020-J081-343
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Naoki Kubota Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.
Eisai Inc.
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP