Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II

Condition(s) targeted: Dementia With Lewy Bodies (DLB)

Intervention: E2020 (Aricept) (Drug); E2020 (Aricept) (Drug); E2020 (Aricept) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Recruiting

Sponsored by: Eisai Limited

Official(s) and/or principal investigator(s):
Itaru Arimoto, Study Director, Affiliation: New Product Development, Clinical Research Center, Eisai Co., Ltd.

Overall contact:
Customer Information Service Department, CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

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

Official title: Double-blind Study of E2020 in Patients With Dementia With Lewy Bodies - Phase II

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Cognitive function, psychiatric symptoms, global clinical function, burden on caregiver.

Secondary outcome: Adverse events, adverse drug reactions, laboratory parameters, vital signs, 12-lead electrocardiogram, Unified Parkinson's Disease Rating Scale Part III.

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion criteria:

Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.

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 past experience of donepezil (Aricept) therapy at the same study institution.

Patients treated with dozepezil in 3 months immediately before starting the observation period.

Patients with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of 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 & Yahr staging score is ≥IV).

Patients whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.

Patients suspected to have a complication of vascular dementia based upon neurological findings.

Customer Information Service Department, CRC and QA, Email: _ML_CLNCL@hhc.eisai.co.jp

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Starting date: November 2007
Last updated: June 8, 2010