A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
This study has been completed.
Sponsor:
Eisai Co., Ltd.
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
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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:
- Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
- Patients who have completed Phase II double-blind study (E2020-J081-431).
- 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:
- 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.
- Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
- Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.
- Patients with severe extrapyramidal disorders (Hoehn & Yahr staging score is > IV).
- 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 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 May 23, 2013