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

Phase 2

Completed

• Conditions: Alzheimer's Type Dementia
• Interventions: Drug: E2020

• Registration Number: NCT01276353
• Lead Sponsor: Eisai Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-01-12
• Study First Submitted QC: 2011-01-12
• Study First Posted: 2011-01-13
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Results First Submitted: 2014-02-24
• Results First Submitted QC: 2014-07-07
• Status Verified: 2014-08
• Results First Posted: 2014-08-01
• Last Update Submitted: 2014-08-05
• Last Update Posted: 2014-08-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	E2020	-
2	E2020	-

Primary Outcome Measures

Name	Time	Method
Maximum Observed Plasma Concentration (Cmax) of E2020 on Visits 2 and 3	Visit 2 [Day1] and Visit 3 [Day 15]

Secondary Outcome Measures

Name	Time	Method
Cmax of E2020 on Visits 2 and 3 According to Cytochrome P450 2D6 (CYP2D6) Phenotype Status	Visit 2 [Day1] and Visit 3 [Day 15]	All subjects were identified as Extensive Metabolizer \[EM\] or Intermediate Metabolizer \[IM\] predicted from their CYP2D6 phenotypes. Ultra-rapid Metabolizer (UM) and Poor Metabolizer (PM) were not identified in any subject. Since the analysis population i