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

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

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

Conditions
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Dementia With Lewy Bodies (DLB)

Intervention / Treatment
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* Drug: E2020


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB. Patients who have completed Phase II double-blind study (E2020-J081-431). 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: 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. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV). Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: E2020<br>* 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.<br>* Other names: Aricept;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lewy Body Disease, Dementia, Clinical Trial, Phase II, E2020, donepezil hydrochloride