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

Eisai

Status and phase

Completed

Phase 2

Conditions

Dementia With Lewy Bodies (DLB)

Treatments

Drug: E2020

Study type

Interventional

Funder types

Industry

Identifiers

E2020-J081-432

Details and patient eligibility

About

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

Enrollment

160 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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.