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:
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

January 14, 2011
January 31, 2014
February 2011
March 2013   (final data collection date for primary outcome measure)
  • 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 ]
  • Co-primary parameters: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 ]
Complete list of historical versions of study NCT01278407 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
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

The purpose of this study is to confirm the efficacy of E2020 in patients with dementia with Lewy bodies (DLB).

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Dementia With Lewy Bodies (DLB)
  • 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.
  • 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.
  • 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
  • Experimental: 1
    Intervention: Drug: E2020
  • Experimental: 2
    Intervention: Drug: E2020
  • Placebo Comparator: 3
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
142
April 2013
March 2013   (final data collection date for primary outcome measure)

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 and Hahr staging score is ? IV)
  6. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50/bpm at screening
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01278407
E2020-J081-341
Not Provided
Eisai Inc. ( Eisai Co., Ltd. )
Eisai Co., Ltd.
Not Provided
Study Director: Masaki Nakagawa Neuroscience Clinical Development Section. JAC PCU
Eisai Inc.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP