Phase 2
N=108
A Long-term, Extension Study of E2020 in Patients With Dementia With Lewy Bodies
Dementia With Lewy Bodies (DLB)
Bottom Line
View on ClinicalTrials.gov: NCT00598650 ↗Enrolled (actual)
108
Serious AEs
7.4%
Results posted
Sep 2014
Primary outcome: Primary: Change From Baseline in Mini-mental State Examination (MMSE) Total — 20.9; 18.6; 0.3; 2 Score on a Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- E2020 (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- Mar 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mini-mental State Examination (MMSE) Total |
20.9; 18.6; 0.3; 2; 0.2; 1.7 | — |
| PRIMARY Change From Baseline in Neuropsychiatric Inventory (NPI) Score of Psychiatric Symptoms |
13.1; 17.8; -1.9; -4.1; -0.7; -4.3 | — |
Summary
The purpose of this study is to evaluate the safety and efficacy of E2020 in patients with Dementia with Lewy Bodies (DLB).
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT00598650). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.