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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier:
NCT00598650
First received: January 10, 2008
Last updated: August 29, 2014
Last verified: August 2014
  Purpose

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


Condition Intervention Phase
Dementia With Lewy Bodies (DLB)
Drug: E2020
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies

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) Total [ Time Frame: Baseline, Week 52, and Week 52 LOCF ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms [ Time Frame: Baseline, Week 52, and Week 52 LOCF ] [ Designated as safety issue: No ]
    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.


Enrollment: 160
Study Start Date: February 2008
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  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 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.
  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: NCT00598650

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

No publications provided

Responsible Party: Eisai Inc. ( Eisai Co., Ltd. )
ClinicalTrials.gov Identifier: NCT00598650     History of Changes
Other Study ID Numbers: E2020-J081-432
Study First Received: January 10, 2008
Results First Received: August 8, 2014
Last Updated: August 29, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Lewy Body Disease
Dementia
Clinical Trial
Phase II
E2020
donepezil hydrochloride

Additional relevant MeSH terms:
Lewy Body Disease
Dementia
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 October 21, 2014