Back to resultsA Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
Primary Purpose
Dementia With Lewy Bodies (DLB)
Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
3 mg Donepezil hydrochloride
5 mg Donepezil hydrochloride
10 mg Donepezil hydrochloride
Placebo
Sponsored by
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
Inclusion criteria:
Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.
Exclusion criteria:
Participants with past experience of donepezil (Aricept) therapy at the same study institution.
Participants treated with donepezil in 3 months immediately before starting the observation period.
Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.
Participants 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
Participants with severe extrapyramidal disorders (Hoehn & Yahr staging score is ≥IV)
Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.
Participants suspected to have a complication of vascular dementia based upon neurological findings.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Placebo Comparator
Arm Label
3 mg Donepezil hydrochloride
5 mg Donepezil hydrochloride
10 mg Donepezil hydrochloride
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)
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: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)
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." Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
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". Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)
J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia.
ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00543855
Brief Title
A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
Official Title
Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
February 2010 (Actual)
Study Completion Date
February 2010 (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 efficacy and safety 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
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
167 (Actual)
8. Arms, Groups, and Interventions
Arm Title
3 mg Donepezil hydrochloride
Arm Type
Experimental
Arm Title
5 mg Donepezil hydrochloride
Arm Type
Experimental
Arm Title
10 mg Donepezil hydrochloride
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
3 mg Donepezil hydrochloride
Other Intervention Name(s)
Aricept, Donepezil hydrochloride, E2020
Intervention Description
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
Intervention Type
Drug
Intervention Name(s)
5 mg Donepezil hydrochloride
Other Intervention Name(s)
Aricept, Donepezil hydrochloride, E2020
Intervention Description
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 84 (10 weeks).
Intervention Type
Drug
Intervention Name(s)
10 mg Donepezil hydrochloride
Other Intervention Name(s)
Aricept, Donepezil hydrochloride, E2020
Intervention Description
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: One 3 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 1- Day 14 (2 weeks).
Followed by one 5 mg Donepezil hydrochloride tablet by mouth plus one Donepezil hydrochloride placebo tablet by mouth, once daily after breakfast for Day 15- Day 42 (4 weeks).
Followed by two 5 mg Donepezil hydrochloride tablets (10 mg) by mouth, once daily after breakfast for Day 43 - Day 84 (6 weeks).
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Observation Period: Two Donepezil hydrochloride placebo tablets once daily by mouth after breakfast for 2 weeks.
Treatment Period: Two Donepezil hydrochloride Placebo tablets by mouth, once daily for 12 weeks (Day 1- Day 84) after breakfast.
Primary Outcome Measure Information:
Title
Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF)
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. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time Frame
Baseline and every 4 weeks up to 12 weeks
Title
Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF)
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." Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time Frame
Baseline and every 4 weeks up to 12 weeks
Title
Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF)
Description
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". Percentage of participants in each category were reported. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time Frame
Baseline and week 12
Title
Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF)
Description
J-ZBI is a Japanese version instrument to measure and assess the level of burden experienced by the principal caregivers of participants with dementia.
ZBI contains 22 items, in which each statement is scored by the caregiver using a 5-point scale. Response options range from 0 (Never) to 4 (Nearly Always). Total score derived from sub-scores; total ranged from 0-88. Higher scores indicate greater burden. Change: mean score at Week 12 LOCF minus mean score at baseline. Values at final evaluation were imputed using a Last Observation Carried Forward (LOCF) method.
Time Frame
Baseline and Week 12
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.
Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.
Exclusion criteria:
Participants with past experience of donepezil (Aricept) therapy at the same study institution.
Participants treated with donepezil in 3 months immediately before starting the observation period.
Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.
Participants 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
Participants with severe extrapyramidal disorders (Hoehn & Yahr staging score is ≥IV)
Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.
Participants suspected to have a complication of vascular dementia based upon neurological findings.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masaki Nakagawa
Organizational Affiliation
Neurosciences Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System.
Official's Role
Study Director
Facility Information:
City
Nagoya
State/Province
Aichi
Country
Japan
City
Obu
State/Province
Aichi
Country
Japan
City
Toyokawa
State/Province
Aichi
Country
Japan
City
Kurume
State/Province
Fukuoka
Country
Japan
City
Omuta
State/Province
Fukuoka
Country
Japan
City
Maebashi
State/Province
Gunma
Country
Japan
City
Miyoshi
State/Province
Hiroshima
Country
Japan
City
Otake
State/Province
Hiroshima
Country
Japan
City
Himeji
State/Province
Hyogo
Country
Japan
City
Kobe
State/Province
Hyogo
Country
Japan
City
Tsukuba
State/Province
Ibaraki
Country
Japan
City
Kahoku
State/Province
Ishikawa
Country
Japan
City
Morioka
State/Province
Iwate
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Nankoku
State/Province
Kochi
Country
Japan
City
Koshi
State/Province
Kumamoto
Country
Japan
City
Joyo
State/Province
Kyoto
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Komoro
State/Province
Nagano
Country
Japan
City
Kashihara
State/Province
Nara
Country
Japan
City
Joetsu
State/Province
Niigata
Country
Japan
City
Sanjo
State/Province
Niigata
Country
Japan
City
Yufu
State/Province
Oita
Country
Japan
City
Sakai
State/Province
Osaka
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Izumo
State/Province
Shimane
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
Country
Japan
City
Kodaira
State/Province
Tokyo
Country
Japan
City
Koto-ku
State/Province
Tokyo
Country
Japan
City
Ota-ku
State/Province
Tokyo
Country
Japan
City
Setagaya-ku
State/Province
Tokyo
Country
Japan
City
Shinjuku-ku
State/Province
Tokyo
Country
Japan
City
Ube
State/Province
Yamaguchi
Country
Japan
City
Akita
Country
Japan
City
Chiba
Country
Japan
City
Fukui
Country
Japan
City
Fukuoka
Country
Japan
City
Kochi
Country
Japan
City
Kumamoto
Country
Japan
City
Kyoto
Country
Japan
City
Osaka
Country
Japan
City
Saitama
Country
Japan
City
Shizuoka
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
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