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A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00598650
Recruitment Status : Completed
First Posted : January 22, 2008
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )

Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).

Condition or disease Intervention/treatment Phase
Dementia With Lewy Bodies (DLB) Drug: E2020 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 160 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
Study Start Date : February 2008
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 1 Drug: E2020
Dosage and administration: Patients will receive oral administration of 1 tablet of 3 mg (E2020) from Day 1 to Day 14 of treatment period, 1 tablet of 5 mg (E2020) from Day 15 onwards once daily after breakfast.
Other Name: Aricept

Primary Outcome Measures :
  1. Change From Baseline in Mini-mental State Examination (MMSE) Total [ Time Frame: Baseline, Week 52, and Week 52 LOCF ]
    MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranged from 0 - 30, where a higher score indicated better cognitive state.

  2. Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms [ Time Frame: Baseline, Week 52, and Week 52 LOCF ]
    NPI measured 10 different domains of psychiatric symptoms including delusion and hallucination. Each domain is scored for: present or absent, frequency, and severity. The score derived from sub-scores; total ranged from "0" to "120," higher score indicated worse neuropsychiatric outcomes.

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria:

  1. Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
  2. Patients who have completed Phase II double-blind study (E2020-J081-431).
  3. Patients having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with patients 3 days a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance and escort their patients on required visits to study institution.

Exclusion criteria:

  1. 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, and/or who underwent brain surgery causing unsolved deficiency.
  2. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
  3. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.
  4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV).
  5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00598650

Sponsors and Collaborators
Eisai Co., Ltd.
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Study Director: Itaru Arimoto New Product Development, Clinical Research Center, Eisai Co., Ltd.

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Responsible Party: Eisai Co., Ltd. Identifier: NCT00598650    
Other Study ID Numbers: E2020-J081-432
First Posted: January 22, 2008    Key Record Dates
Results First Posted: September 3, 2014
Last Update Posted: September 3, 2014
Last Verified: August 2014
Keywords provided by Eisai Inc. ( Eisai Co., Ltd. ):
Lewy Body Disease
Clinical Trial
Phase II
donepezil hydrochloride
Additional relevant MeSH terms:
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Lewy Body Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders
Neurodegenerative Diseases
Parkinsonian Disorders
Basal Ganglia Diseases
Movement Disorders
Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents