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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01539031
First received: February 21, 2012
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Alzheimer's Type Dementia
Drug: E2020
Phase 3

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

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • 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)


Estimated Enrollment: 330
Study Start Date: March 2012
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 10 mg group 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

Active Comparator: 23 mg group 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


  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539031

  Show 54 Study Locations
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Naoki Kubota Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Product Creation Systems, Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT01539031     History of Changes
Other Study ID Numbers: E2020-J081-343
Study First Received: February 21, 2012
Last Updated: July 10, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
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

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies
Donepezil
Central Nervous System Agents
Cholinergic Agents
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nootropic Agents
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 22, 2014