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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:
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
History of Changes
  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:

U.S. FDA Resources

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

  1. Patients diagnosed as probable dementia with lewy bodies (DLB) according to the diagnostic criteria for DLB
  2. 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
  3. Clinical Dementia Rating (CDR) score is ≥ 0.5
  4. Mini-Mental State Examination (MMSE) score is ≥ 10 and ≤ 26

Exclusion Criteria

  1. Patients diagnosed with Parkinson's disease with dementia (PDD)
  2. Patients who received anti-dementia drug therapy at the same institution
  3. Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
  4. 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

  5. Patients with severe extrapyramidal disorders (Hoehn & Hahr staging score is

    ≥ IV)

  6. 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

  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: 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 June 18, 2013