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Completed

NCT Number: NCT02345213

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

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

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Key information

Conditions

Dementia, Lewy Body Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Saitama, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients diagnosed with probable DLB according to the diagnostic criteria for DLB
  • 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
  • Clinical Dementia Rating (CDR) score is greater than or equal to 0.5
  • Mini-Mental State Examination (MMSE) score is greater than or equal to 10 and less than or equal to 26

Exclusion criteria

  • Patients diagnosed with Parkinson's disease with dementia (PDD)
  • Patients who have received anti-dementia drug therapy within 12 weeks before the start of the observation period
  • 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
  • Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than or equal to IV)
  • Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/minute at screening test

Treatment and study plan

E2020

Drug

E2020 tablets will be orally administered once daily after breakfast

Placebo

Drug

Matching placebo tablets will be orally administered once daily after breakfast

Primary outcomes

  1. 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".

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jan 26, 2015
Registry last updated
Jan 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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