A Long-term, Extension Study of E2020 i… | Clinical Trial

Key information

Conditions

Dementia With Lewy Bodies (DLB) Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Dementia Lewy Body Disease Mental Disorders Movement Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

E2020

Drug

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 names: Aricept

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Eisai Co., Ltd.

Industry

Registry information

Important dates

Study start: 2008
Primary completion: 2011
Study completion: 2011
First posted: Jan 22, 2008
Registry last updated: Sep 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed