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A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT00598650•Eisai Co., Ltd.

Summary

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

Eligibility

Age

50 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients diagnosed as probable Dementia with Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
•2. Patients who have completed Phase II double-blind study (E2020-J081-431).
•3. 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

•1. 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.
•2. Patients with severe complication of cardiovascular, hepatic, renal, hematological, or other diseases unable to secure the safety.
•3. Pregnant or lactating women, or women who are willing to become pregnant no later than 1 month after the scheduled study completion.
•4. Patients with severe extrapyramidal disorders (Hoehn and Yahr staging score is greater than IV).
•5. Patients whose systolic blood pressure is less than 90 mmHg or pulse rate is less than 50 beats/min.

Key Dates

Start Date

February 1, 2008

Primary Completion Date

March 1, 2011

Completion Date

March 1, 2011

Last Updated

September 3, 2014

Enrollment

160

ACTUAL participants

Conditions

Dementia With Lewy Bodies (DLB)

Interventions

E2020

DRUG

Retrospective Observational Study of Blood-based Biomarkers in the Diagnosis and Monitoring of Patients With a Neurodegenerative Disease or Mental Disorder

NCT07314190

Alzheimer DiseaseDementia With Lewy Bodies (DLB)+5 more

View study

COMPLETEDPHASE3

A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase

NCT01278407

Dementia With Lewy Bodies (DLB)

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 3, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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