A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

Phase 2

Completed

• Conditions: Dementia With Lewy Bodies (DLB)
• Interventions: Drug: E2020

• Registration Number: NCT00598650
• Lead Sponsor: Eisai Co., Ltd.

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-10
• Study First Submitted QC: 2008-01-10
• Study First Posted: 2008-01-22
• Study Start: 2008-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2014-08
• Results First Submitted: 2014-08-08
• Results First Submitted QC: 2014-08-29
• Last Update Submitted: 2014-08-29
• Results First Posted: 2014-09-03
• Last Update Posted: 2014-09-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	E2020	-

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Mini-mental State Examination (MMSE) Total	Baseline, Week 52, and Week 52 LOCF	MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.
Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms	Baseline, Week 52, and Week 52 LOCF	NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated worse neuropsychiatric outcomes.