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

NCT ID: NCT00598650

Last Updated: 2014-09-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 160 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-02-29
• Study Completion Date: 2011-03-31

Brief Summary

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

Conditions

Dementia With Lewy Bodies (DLB)

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

E2020

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Aricept

Eligibility 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.

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eisai Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Itaru Arimoto

Role: STUDY_DIRECTOR

New Product Development, Clinical Research Center, Eisai Co., Ltd.

Other Identifiers

E2020-J081-432

Identifier Type: -

Identifier Source: org_study_id