Clinical Trial: A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
Brief Summary: The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).
Detailed Summary:
Sponsor: Eisai Co., Ltd.
Current Primary Outcome:
- Change From Baseline in Mini-mental State Examination (MMSE) Total [ Time Frame: Baseline, Week 52, and Week 52 LOCF ]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 ]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.
Original Primary Outcome: Adverse events, UPDRS. [ Time Frame: 12 weeks ]
Current Secondary Outcome:
Original Secondary Outcome: Cognitive function, psychiatric symptom and burden on caregiver. [ Time Frame: 12 weeks ]
Information By: Eisai Inc.
Dates:
Date Received: January 10, 2008
Date Started: February 2008
Date Completion:
Last Updated: August 29, 2014
Last Verified: August 2014
