Phase 3
N=142
A Study of E2020 in Patients With Dementia With Lewy Bodies (DLB), Followed by a Long-term Extension Phase
Dementia With Lewy Bodies (DLB)
Bottom Line
View on ClinicalTrials.gov: NCT01278407 ↗Enrolled (actual)
142
Serious AEs
11.3%
Results posted
Nov 2015
Primary outcome: Primary: Change From Baseline in Mini-Mental State Examination (MMSE) Score — 0.6; 1.4; 2.2 Units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Donepezil 5 mg (Drug); Donepezil 10 mg (Drug); Donepezil matched placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Mini-Mental State Examination (MMSE) Score |
0.6; 1.4; 2.2 | — |
| PRIMARY Change From Baseline in Neuropsychiatric Inventory (NPI-2) Score |
-2.0; -1.7; -2.9 | — |
Summary
The purpose of this study is to confirm the 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 consensus diagnostic criteria for DLB
- Patients having caregivers throughout the study who submited written consent to cooperate with this study, who routinely stayed with patients 3 days or more a week (at least 4 hours a day), provided patients' information necessary for this study, assisted treatment compliance, and escorted the patients on required visits to study institution
- Clinical Dementia Rating (CDR) score ≥ 0.5
- Mini-Mental State Examination (MMSE) score of 10 to 26
Exclusion Criteria
- Patients diagnosed with Parkinson's disease with dementia (PDD)
- Patients who received anti-dementia drug therapy at the same institution
- Patients who received anti-dementia drug therapy within 12 weeks before start of Screening
- 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, or a history of brain surgery causing unrecovered deficiency
- Patients with severe extrapyramidal disorders (Hoehn and Hahr staging score ≥ IV)
- Patients whose systolic blood pressure was less than 90 mmHg or pulse rate was less than 50 bpm at screening
Data sourced from ClinicalTrials.gov (NCT01278407). 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.