A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
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|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|
|Actual Primary Completion Date :||March 2011|
|Actual 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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.|