A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II
1 other identifier
interventional
167
1 country
43
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of E2020 in patients with Dementia with Lewy Bodies (DLB).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Nov 2007
43 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2007
CompletedFirst Posted
Study publicly available on registry
October 15, 2007
CompletedStudy Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
February 18, 2013
CompletedMarch 8, 2013
March 1, 2013
2.3 years
October 4, 2007
January 16, 2013
March 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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.
Baseline and every 4 weeks up to 12 weeks
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.
Baseline and every 4 weeks up to 12 weeks
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.
Baseline and week 12
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.
Baseline and Week 12
Study Arms (4)
3 mg Donepezil hydrochloride
EXPERIMENTAL5 mg Donepezil hydrochloride
EXPERIMENTAL10 mg Donepezil hydrochloride
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
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.
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).
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).
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Eisai Co., Ltd.lead
Study Sites (43)
Unknown Facility
Nagoya, Aichi-ken, Japan
Unknown Facility
Ōbu, Aichi-ken, Japan
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Toyokawa, Aichi-ken, Japan
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Akita, Akita, Japan
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Chiba, Chiba, Japan
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Fukui-shi, Fukui, Japan
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Fukuoka, Fukuoka, Japan
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Kurume, Fukuoka, Japan
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Omuta, Fukuoka, Japan
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Maebashi, Gunma, Japan
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Miyoshi, Hiroshima, Japan
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Ōtake, Hiroshima, Japan
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Himeji, Hyōgo, Japan
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Kobe, Hyōgo, Japan
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Tsukuba, Ibaraki, Japan
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Kahoku, Ishikawa-ken, Japan
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Morioka, Iwate, Japan
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Yokohama, Kanagawa, Japan
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Kochi, Kochi, Japan
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Nankoku, Kochi, Japan
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Kōshi, Kumamoto, Japan
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Kumamoto, Kumamoto, Japan
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Jōyō, Kyoto, Japan
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Kyoto, Kyoto, Japan
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Sendai, Miyagi, Japan
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Komoro, Nagano, Japan
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Kashihara, Nara, Japan
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Jōetsu, Niigata, Japan
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Sanjō, Niigata, Japan
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Yufu, Oita Prefecture, Japan
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Osaka, Osaka, Japan
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Sakai, Osaka, Japan
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Suita, Osaka, Japan
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Saitama, Saitama, Japan
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Izumo, Shimane, Japan
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Shizuoka, Shizuoka, Japan
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Bunkyo-ku, Tokyo, Japan
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Kodaira, Tokyo, Japan
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Koto-ku, Tokyo, Japan
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Ōta-ku, Tokyo, Japan
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Setagaya-ku, Tokyo, Japan
Unknown Facility
Shinjuku-ku, Tokyo, Japan
Unknown Facility
Ube, Yamaguchi, Japan
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Masaki Nakagawa, Study Director
- Organization
- Eisai Co., Ltd.
Study Officials
- STUDY DIRECTOR
Masaki Nakagawa
Neurosciences Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2007
First Posted
October 15, 2007
Study Start
November 1, 2007
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
March 8, 2013
Results First Posted
February 18, 2013
Record last verified: 2013-03