A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
This study is ongoing, but not recruiting participants.
Sponsor:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT01278407
First received: January 14, 2011
Last updated: December 12, 2012
Last verified: December 2012
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Purpose
The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).
| Condition | Intervention | Phase |
|---|---|---|
|
Dementia With Lewy Bodies (DLB) |
Drug: E2020 Drug: Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase |
Resource links provided by NLM:
Further study details as provided by Eisai Inc.:
Primary Outcome Measures:
- Change from baseline in Mini Mental State Examination (MMSE) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
- Change from baseline in Neuropsychiatric Inventory (NPI) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 142 |
| Study Start Date: | February 2011 |
| Estimated Study Completion Date: | May 2013 |
| Estimated Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Drug: E2020
E2020 tablets will be orally administered once daily after breakfast for 52 weeks: 5 mg group: Weeks 1-2 E2020 3 mg, Weeks 3-24 E2020 5 mg, Weeks 25-52 E2020 10 mg.
|
| Experimental: 2 |
Drug: E2020
E2020 tablets will be orally administered once daily after breakfast for 52 weeks: 10 mg group: Weeks 1-2 E2020 3 mg, Weeks 3-6 E2020 5 mg, Weeks 7-52 E2020 10 mg.
|
| Placebo Comparator: 3 |
Drug: Placebo
Matching placebo tablets will be orally administered once daily after breakfast for 52 weeks: Placebo group: Weeks 1-16 placebo, Weeks 17-18 E2020 3 mg, Weeks 19-24 E2020 5 mg, Weeks 25-52 E2020 10 mg
|
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria
- Patients diagnosed as probable dementia with lewy bodies (DLB) according to the diagnostic criteria for DLB
- Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients 3 days or more 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
- Clinical Dementia Rating (CDR) score is ≥ 0.5
- Mini-Mental State Examination (MMSE) score is ≥ 10 and ≤ 26
Exclusion Criteria
- Patients diagnosed with Parkinson's disease with dementia (PDD)
- Patients who received anti-dementia drug therapy at the same institution
- Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
- 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
Patients with severe extrapyramidal disorders (Hoehn & Hahr staging score is
≥ IV)
- Patients whose systolic blood pressure is < 90 mmHg or pulse rate is < 50/bpm at screening
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278407
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| Japan | |
| Anjo-shi, Aichi, Japan | |
| Nagoya-shi, Aichi, Japan | |
| Toyokawa-shi, Aichi, Japan | |
| Chiba-shi, Chiba, Japan | |
| Fukui-shi, Fukui, Japan | |
| Yoshida-gun, Fukui, Japan | |
| Fukuoka-shi, Fukuoka, Japan | |
| Kitakyushu-shi, Fukuoka, Japan | |
| Omuta-shi, Fukuoka, Japan | |
| Gifu-shi, Gifu, Japan | |
| Mizunami-shi, Gifu, Japan | |
| Fujioka-shi, Gunma, Japan | |
| Maebashi-shi, Gunma, Japan | |
| Kure-shi, Hiroshima, Japan | |
| Miyoshi-shi, Hiroshima, Japan | |
| Otake-shi, Hiroshima, Japan | |
| Obihiro-shi, Hokkaido, Japan | |
| Sapporo-shi, Hokkaido, Japan | |
| Himeji-shi, Hyogo, Japan | |
| Kobe-shi, Hyogo, Japan | |
| Yabu-shi, Hyogo, Japan | |
| Bando-shi, Ibaraki, Japan | |
| Hitachi-shi, Ibaraki, Japan | |
| Kahoku-shi, Ishikawa, Japan | |
| Morioka-shi, Iwate, Japan | |
| Fujisawa-shi, Kanagawa, Japan | |
| Kochi-shi, Kochi, Japan | |
| Koshi-shi, Kumamoto, Japan | |
| Kumamoto-shi, Kumamoto, Japan | |
| Kyoto-shi, Kyoto, Japan | |
| Uji-shi, Kyoto, Japan | |
| Sendai-shi, Miyagi, Japan | |
| Higashimorokata-gun, Miyazaki, Japan | |
| Ina-shi, Nagano, Japan | |
| Kitaazumi-gun, Nagano, Japan | |
| Matsumoto-shi, Nagano, Japan | |
| Nishisonogi-gun, Nagasaki, Japan | |
| Nagaoka-shi, Niigata, Japan | |
| Sanjo-shi, Niigata, Japan | |
| Tsubame-shi, Niigata, Japan | |
| Yufu-shi, Oita, Japan | |
| Osaka-shi, Osaka, Japan | |
| Sakai-shi, Osaka, Japan | |
| Sennan-shi, Osaka, Japan | |
| Suita-shi, Osaka, Japan | |
| Ageo-shi, Saitama, Japan | |
| Kasukabe-shi, Saitama, Japan | |
| Saitama-shi, Saitama, Japan | |
| Fuji-shi, Shizuoka, Japan | |
| Hamamatsu-shi, Shizuoka, Japan | |
| Shizuoka-shi, Shizuoka, Japan | |
| Koto-ku, Tokyo, Japan | |
| Ota-ku, Tokyo, Japan | |
| Setagaya-ku, Tokyo, Japan | |
| Shinjuku-ku, Tokyo, Japan | |
| Suginami-ku, Tokyo, Japan | |
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
| Study Director: | Masaki Nakagawa | Neuroscience Clinical Development Section. JAC PCU |
More Information
No publications provided
| Responsible Party: | Eisai Inc. ( Eisai Co., Ltd. ) |
| ClinicalTrials.gov Identifier: | NCT01278407 History of Changes |
| Other Study ID Numbers: | E2020-J081-341 |
| Study First Received: | January 14, 2011 |
| Last Updated: | December 12, 2012 |
| Health Authority: | Japan: Ministry of Health, Labor and Welfare |
Keywords provided by Eisai Inc.:
|
DLB Dementia with Lewy bodies Lewy Body Disease Dementia |
E2020 Donepezil Aricept |
Additional relevant MeSH terms:
|
Dementia Lewy Body Disease Brain Diseases Central Nervous System Diseases Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Parkinsonian Disorders Basal Ganglia Diseases Movement Disorders Neurodegenerative Diseases |
Donepezil Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Cholinergic Agents Neurotransmitter Agents Physiological Effects of Drugs Nootropic Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013