Trial record 7 of 45 for:    Dementia With Lewy Bodies

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: October 10, 2011
Last verified: October 2011
  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 (Aricept)
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:
  • Number of patients with adverse events as a measure of safety. [ Time Frame: Every 4 weeks ] [ Designated as safety issue: Yes ]

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 (Aricept)
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 & Yahr staging score is > IV).
  5. Patients whose systolic blood pressure is < 90 mmHg or pulse rate is < 50 beats/min.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00598650

Locations
Japan
Nagoya, Aichi, Japan
Obu, Aichi, Japan
Toyokawa, Aichi, Japan
Kurume, Fukuoka, Japan
Omuta, Fukuoka, Japan
Maebashi, Gunma, Japan
Miyoshi, Hiroshima, Japan
Otake, Hiroshima, Japan
Himeji, Hyogo, Japan
Kobe, Hyogo, Japan
Tsukuba, Ibaraki, Japan
Kahoku, Ishikawa, Japan
Morioka, Iwate, Japan
Yokohama, Kanagawa, Japan
Nankoku, Kochi, Japan
Koshi, Kumamoto, Japan
Joyo, Kyoto, Japan
Sendai, Miyagi, Japan
Komoro, Nagano, Japan
Kashihara, Nara, Japan
Joetsu, Niigata, Japan
Sanjo, Niigata, Japan
Yufu, Oita, Japan
Sakai, Osaka, Japan
Suita, Osaka, Japan
Izumo, Shimane, Japan
Bunkyo-ku, Tokyo, Japan
Kodaira, Tokyo, Japan
Koto-ku, Tokyo, Japan
Ota-ku, Tokyo, Japan
Setagaya-ku, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Ube, Yamaguchi, Japan
Akita, Japan
Chiba, Japan
Fukui, Japan
Fukuoka, Japan
Kochi, Japan
Kumamoto, Japan
Kyoto, Japan
Osaka, Japan
Saitama, Japan
Shizuoka, Japan
Sponsors and Collaborators
Eisai Co., Ltd.
Investigators
Study Director: Masaki Nakagawa Neuroscience Clinical Development Section. JAC PCU. 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
Last Updated: October 10, 2011
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:
Dementia
Lewy Body Disease
Delirium, Dementia, Amnestic, Cognitive Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
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 April 14, 2014