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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02345213
Recruitment Status : Completed
First Posted : January 26, 2015
Last Update Posted : January 8, 2019
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

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

Condition or disease Intervention/treatment Phase
Dementia, Lewy Body Lewy Body Disease Drug: E2020 Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Post-Marketing Clinical Study of Aricept in Patients With Dementia With Lewy Bodies (DLB)
Actual Study Start Date : March 1, 2015
Actual Primary Completion Date : May 15, 2017
Actual Study Completion Date : March 26, 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  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".


Eligibility Criteria
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Ages Eligible for Study:   50 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02345213


Locations
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Japan
Saitama, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
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Study Director: Megumi Ohdake Drug Fostering and Evolution Coordination Department, Eisai Co., Ltd.
More Information
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Responsible Party: Eisai Co., Ltd.
ClinicalTrials.gov Identifier: NCT02345213    
Other Study ID Numbers: E2020-J081-419
First Posted: January 26, 2015    Key Record Dates
Last Update Posted: January 8, 2019
Last Verified: December 2017
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
DLB
Dementia with Lewy bodies
Lewy Body Disease
Dementia
 E2020
Donepezil
Aricept
Additional relevant MeSH terms:
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Dementia
Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
 Movement Disorders
Synucleinopathies
Donepezil
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents