A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)

January 7, 2019 updated by: Eisai Co., Ltd.
The purpose of this study is to confirm the efficacy of Aricept in patients with dementia with Lewy bodies (DLB).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. Patients diagnosed with probable DLB according to the diagnostic criteria for DLB
  2. Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients at least 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution
  3. Clinical Dementia Rating (CDR) score is greater than or equal to 0.5
  4. Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26

Exclusion Criteria

  1. Patients diagnosed with Parkinson's disease with dementia (PDD)
  2. Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period
  3. Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsy, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, or a history of brain surgery causing unrecovered deficiency
  4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV)
  5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: E2020

Treatment period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, Weeks 7-12 E2020 10 mg.

Extension period: Weeks 1-6 E2020 10 mg, After Week 7 up to week 60 E2020 10 mg.
Drug: E2020
E2020 tablets will be orally administered once daily after breakfast
Placebo Comparator: Placebo

Treatment period: Weeks 1-12 placebo

Extension period: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, After Week 7 up to week 60 E2020 10 mg.
Drug: Placebo
Matching placebo tablets will be orally administered once daily after breakfast

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinician's Interview-Based Impression of Change, Plus Caregiver Input Version (CIBIC-plus)
Time Frame: Up to 12 weeks
CIBIC plus is a clinician's interview-based impression of change plus the caregiver's input. It is a seven-point categorical assessment scale for evaluating global clinical function, ranging from "markedly improved" to "markedly worse".
Up to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eisai Co., Ltd.

Investigators

  • Study Director: Megumi Ohdake, Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

May 15, 2017

Study Completion (Actual)

March 26, 2018

Study Registration Dates

First Submitted

January 19, 2015

First Submitted That Met QC Criteria

January 19, 2015

First Posted (Estimate)

January 26, 2015

Study Record Updates

Last Update Posted (Actual)

January 8, 2019

Last Update Submitted That Met QC Criteria

January 7, 2019

Last Verified

December 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E2020-J081-419

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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