A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
This study has been completed.
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: January 31, 2014
Last verified: January 2014
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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) 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 ]
| Enrollment: | 142 |
| Study Start Date: | February 2011 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | March 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 and Hahr staging score is ? IV)
- Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50/bpm at screening
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278407
Show 56 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01278407
Show 56 Study Locations
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: | January 31, 2014 |
| 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 Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders |
Donepezil Central Nervous System Agents Cholinergic Agents Cholinesterase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Nootropic Agents Pharmacologic Actions Physiological Effects of Drugs Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015