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

Dementia With Lewy Bodies (DLB) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598650
• Other study ID #: E2020-J081-432
• Status: Completed
• Phase: Phase 2
• First received: January 10, 2008
• Last updated: August 29, 2014
• Start date: February 2008
• Est. completion date: March 2011

Study information

• Verified date: August 2014
• Source: Eisai Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dementia
• Dementia With Lewy Bodies (DLB)
• Lewy Body Disease

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Eisai Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Mini-mental State Examination (MMSE) Total	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.	Baseline, Week 52, and Week 52 LOCF	No
Primary	Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms	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.	Baseline, Week 52, and Week 52 LOCF	No