A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
NCT ID: NCT00543855
Last Updated: 2013-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
167 participants
INTERVENTIONAL
2007-11-30
2010-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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3 mg Donepezil hydrochloride
3 mg Donepezil hydrochloride
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.
5 mg Donepezil hydrochloride
5 mg Donepezil hydrochloride
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).
10 mg Donepezil hydrochloride
10 mg Donepezil hydrochloride
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).
Placebo
Placebo
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.
Interventions
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3 mg Donepezil hydrochloride
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.
5 mg Donepezil hydrochloride
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).
10 mg Donepezil hydrochloride
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).
Placebo
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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 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.
50 Years
ALL
No
Sponsors
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Eisai Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Masaki Nakagawa
Role: STUDY_DIRECTOR
Neurosciences Clinical Development Section, Japan / Asia Clinical Research, Product Creation Unit, Eisai Product Creation System.
Locations
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Nagoya, Aichi-ken, Japan
Ōbu, Aichi-ken, Japan
Toyokawa, Aichi-ken, Japan
Akita, Akita, Japan
Chiba, Chiba, Japan
Fukui-shi, Fukui, Japan
Fukuoka, Fukuoka, Japan
Kurume, Fukuoka, Japan
Omuta, Fukuoka, Japan
Maebashi, Gunma, Japan
Miyoshi, Hiroshima, Japan
Ōtake, Hiroshima, Japan
Himeji, Hyōgo, Japan
Kobe, Hyōgo, Japan
Tsukuba, Ibaraki, Japan
Kahoku, Ishikawa-ken, Japan
Morioka, Iwate, Japan
Yokohama, Kanagawa, Japan
Kochi, Kochi, Japan
Nankoku, Kochi, Japan
Kōshi, Kumamoto, Japan
Kumamoto, Kumamoto, Japan
Jōyō, Kyoto, Japan
Kyoto, Kyoto, Japan
Sendai, Miyagi, Japan
Komoro, Nagano, Japan
Kashihara, Nara, Japan
Jōetsu, Niigata, Japan
Sanjō, Niigata, Japan
Yufu, Oita Prefecture, Japan
Osaka, Osaka, Japan
Sakai, Osaka, Japan
Suita, Osaka, Japan
Saitama, Saitama, Japan
Izumo, Shimane, Japan
Shizuoka, Shizuoka, Japan
Bunkyo-ku, Tokyo, Japan
Kodaira, Tokyo, Japan
Koto-ku, Tokyo, Japan
Ōta-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Ube, Yamaguchi, Japan
Countries
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Other Identifiers
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E2020-J081-431
Identifier Type: -
Identifier Source: org_study_id
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