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A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

NCT01278407 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 142

Last updated 2023-06-29

Study results available
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Summary

The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

Conditions

  • Dementia With Lewy Bodies (DLB)

Interventions

DRUG

Donepezil 5 mg

Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg

DRUG

Donepezil 10 mg

Donepezil tablets orally, once daily, uptitrated from 3 to 5 mg and then the dose was increased to 10 mg

DRUG

Donepezil matched placebo

Sponsors & Collaborators

  • Eisai Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Masaki Nakagawa · Neuroscience Clinical Development Section. JAC PCU

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-02-28
Primary Completion
2013-03-31
Completion
2013-04-30

Countries

  • Japan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01278407 on ClinicalTrials.gov