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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

July 26, 2011
July 10, 2014
September 2011
August 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01404169 on ClinicalTrials.gov Archive Site
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.
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.
Not Provided
Not Provided
 
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
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

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.

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
    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.
  • Drug: Placebo
    Placebo matched to donepezil 5 mg or 10 mg tablets taken orally once daily for 24 weeks.
  • Experimental: 1
    Intervention: Drug: E2020
  • Placebo Comparator: 2
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
260
September 2014
August 2014   (final data collection date for primary outcome measure)

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
Both
50 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT01404169
E2020-C086-339
Not Provided
Eisai Inc. ( Eisai Limited )
Eisai Limited
Not Provided
Study Director: Naoki Kubota Neuroscience Clinical Development Section, Japan/Asia Clinical Research Product Creation Unit, Eisai Co., Ltd.
Eisai Inc.
July 2014

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