A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
|ClinicalTrials.gov Identifier: NCT00598650|
Recruitment Status : Completed
First Posted : January 22, 2008
Results First Posted : September 3, 2014
Last Update Posted : September 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Dementia With Lewy Bodies (DLB)||Drug: E2020||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies|
|Study Start Date :||February 2008|
|Primary Completion Date :||March 2011|
|Study Completion Date :||March 2011|
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
- 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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00598650
|Study Director:||Itaru Arimoto||New Product Development, Clinical Research Center, Eisai Co., Ltd.|