A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier:
NCT01404169
First received: July 26, 2011
Last updated: July 10, 2014
Last verified: July 2014
  Purpose

The objective is to demonstrate that donepezil hydrochloride 10 mg/day has superior efficacy compared with placebo in cognitive function in Chinese subjects with severe Alzheimer's Disease.


Condition Intervention Phase
Alzheimer's Type Dementia
Drug: E2020
Drug: Placebo
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: A 24-weeks, Multi-center, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Donepezil Hydrochloride in Chinese Subjects With Severe Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

Primary Outcome Measures:
  • The change in the total Severe Impairment Battery (SIB) score at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    All statistical tests will be conducted at the 0.05 level of significance (two-tailed). A positive outcome will be declared if for the primary efficacy endpoint as measured by the Severe Impairment Battery (SIB), the change from Baseline to Week 24 in the total SIB score last observation carried forward (LOCF) demonstrates superiority for donepezil 10 mg, compared with placebo.


Secondary Outcome Measures:
  • Clinician Interview-Based Impression of Severity (CIBIC)+ overall score at Week 24 [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    An ANCOVA with embedded Cochran-Mantel-Haenszel (CMH) test will be used with the CIBIC+ and center in the model. Overall change from Baseline in scores at Week 24 (LOCF) will be analyzed with the same model as the SIB.


Estimated Enrollment: 260
Study Start Date: September 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: E2020
In titration period, donepezil 5-mg tablet will be taken orally once daily for 6 weeks, following donepezil 10 mg tablets taken orally once daily for 18 weeks in the maintenance period.
Placebo Comparator: 2 Drug: Placebo
Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Written informed consent (IC) will be obtained from the subject (if possible) or from the subject's legal guardian or legal representative prior to beginning screening activities.
  • Subject age range: male and female subjects 50 to 90 years of age, inclusive
  • Diagnosis: diagnostic evidence of probable Alzheimer's Disease (AD) consistent with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR) and National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria
  • MMSE 1 to 12 inclusive, at both Screening and Baseline SIB less than or equal to 90 and greater than or equal to 10 at both Screening and Baseline
  • Comorbid medical conditions must be clinically stable prior to Baseline, unless otherwise specified.

Exclusion Criteria

  • Subjects with a known history of disorders that affect cognition or the ability to assess cognition, but are distinguishable from AD
  • Evidence of focal disease to account for dementia on any cranial image MRI or CT.
  • Subjects with dementia complicated by other organic disease or AD with delirium according to DSM-IV criteria
  • Subjects who cannot swallow or who have difficulty swallowing whole tablets, as tablets should not be broken or crushed
  • Illiteracy prior to AD
  • Subjects who are unwilling or unable to fulfill the requirements of the study
  • Treatment with another cholinesterase inhibitor and/or memantine in the 3 months prior to Screening
  • Subjects with a poor response (tolerability) to prior exposure to donepezil
  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: NCT01404169

  Show 32 Study Locations
Sponsors and Collaborators
Eisai Limited
Investigators
Study Director: Naoki Kubota Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.
  More Information

No publications provided

Responsible Party: Eisai Inc. ( Eisai Limited )
ClinicalTrials.gov Identifier: NCT01404169     History of Changes
Other Study ID Numbers: E2020-C086-339
Study First Received: July 26, 2011
Last Updated: July 10, 2014
Health Authority: China: Food and Drug Administration

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

ClinicalTrials.gov processed this record on September 18, 2014