A Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia
This study has been completed.
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
First received: January 12, 2011
Last updated: December 27, 2012
Last verified: December 2012
The purpose of this study is to compare 23 mg donepezil sustained release (SR) to the currently marketed formulation of 10 mg donepezil immediate release (IR) in patients with severe Alzheimer's disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized, Double Blind, Parallel-Group Comparison Study Versus E2020 10mg Followed by an Open-label Extension Phase to Explore the Safety of E2020 SR 23 mg in Japanese Subjects With Severe Alzheimer's Type Dementia|
Resource links provided by NLM:
MedlinePlus related topics: Alzheimer's Disease Brain Diseases Degenerative Nerve Diseases Delirium Dementia Mental Disorders Neurologic DiseasesU.S. FDA Resources
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- To explore the safety and the tolerability of E2020 SR 23 mg: number of subjects with AEs will be measured. [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
|Study Start Date:||January 2011|
|Study Completion Date:||April 2012|
|Primary Completion Date:||April 2012 (Final data collection date for primary outcome measure)|
Patients will take study medication orally, once daily, for 2 weeks according to a double-dummy design in the double blind phase: 23 mg donepezil sustained release (SR) concurrently with placebo identical in appearance to the 10 mg donepezil immediate release (IR) formulation
|Active Comparator: 2||
10 mg donepezil immediate release (IR) concurrently with placebo identical in appearance to the 23 mg donepezil sustained release (SR) formulation. All patients who complete the double blind phase will take 23 mg donepezil sustained release (SR) orally, once daily, for 52 weeks in the Open-label Extension phase.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01276353
|Kitakyushu, Fukuoka, Japan|
|Mizunami, Gifu, Japan|
|Yokosuka, Kanagawa, Japan|
|Sanjo, Niigata, Japan|
|Kurashiki, Okayama, Japan|
|Fuji, Shizuoka, Japan|
|Hachioji, Tokyo, Japan|
|Kodaira, Tokyo, Japan|
Sponsors and Collaborators
Eisai Co., Ltd.
|Study Director:||Naoki Kubota||Neuroscience Clinical Development Section. JAC PCU. Eisai Co., Ltd.|