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

Primary Purpose

Dementia With Lewy Bodies (DLB)

Status
Completed
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
E2020
Sponsored by
Eisai Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dementia With Lewy Bodies (DLB) focused on measuring Lewy Body Disease, Dementia, Clinical Trial, Phase II, E2020, donepezil hydrochloride

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion criteria:

  1. Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
  2. Patients who have completed Phase II double-blind study (E2020-J081-431).
  3. Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution.

Exclusion criteria:

  1. 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, and/or who underwent brain surgery causing unsolved deficiency.
  2. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
  3. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.
  4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV).
  5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    1

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change From Baseline in Mini-mental State Examination (MMSE) Total
    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
    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.

    Secondary Outcome Measures

    Full Information

    First Posted
    January 10, 2008
    Last Updated
    August 29, 2014
    Sponsor
    Eisai Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00598650
    Brief Title
    A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
    Official Title
    A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2014
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2008 (undefined)
    Primary Completion Date
    March 2011 (Actual)
    Study Completion Date
    March 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Eisai Co., Ltd.

    4. Oversight

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Dementia With Lewy Bodies (DLB)
    Keywords
    Lewy Body Disease, Dementia, Clinical Trial, Phase II, E2020, donepezil hydrochloride

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    160 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    1
    Arm Type
    Experimental
    Intervention Type
    Drug
    Intervention Name(s)
    E2020
    Other Intervention Name(s)
    Aricept
    Intervention Description
    Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
    Primary Outcome Measure Information:
    Title
    Change From Baseline in Mini-mental State Examination (MMSE) Total
    Description
    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.
    Time Frame
    Baseline, Week 52, and Week 52 LOCF
    Title
    Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms
    Description
    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.
    Time Frame
    Baseline, Week 52, and Week 52 LOCF

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    50 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB. Patients who have completed Phase II double-blind study (E2020-J081-431). Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution. Exclusion criteria: 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, and/or who underwent brain surgery causing unsolved deficiency. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV). Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Itaru Arimoto
    Organizational Affiliation
    New Product Development, Clinical Research Center, Eisai Co., Ltd.
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Learn more about this trial

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

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