A Double-blind Study of E2020 (Donepezil Hydrochloride) in Patients With Dementia With Lewy Bodies (DLB) (Study E2020-J081-431)
Dementia With Lewy Bodies (DLB)
Bottom Line
View on ClinicalTrials.gov: NCT00543855 ↗Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 3 mg Donepezil hydrochloride (Drug); 5 mg Donepezil hydrochloride (Drug); 10 mg Donepezil hydrochloride (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Eisai Co., Ltd.
- Primary completion
- Feb 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Cognitive Function: Change From Baseline in Mini-mental State Examination (MMSE) Total at Week 12 Last Observation Carried Forward (LOCF) |
20.1; 19.7; 19.7; 18.2; 1.2; 3.5 | — |
| PRIMARY Psychiatric Symptoms: Change From Baseline in Neuropsychiatric Inventory (NPI) Total at Week 12 Last Observation Carried Forward (LOCF) |
20.9; 14.2; 19.1; 18.4; -4.3; -5.9 | — |
| PRIMARY Global Clinical Function: Clinician's Interview-Based Impression of Change Plus Caregiver Input (CIBIC-plus) Total at Week 12 Last Observation Carried Forward (LOCF) |
3.6; 17.9; 3.8; 0; 17.9; 17.9 | — |
| PRIMARY Burden on Caregiver: Change From Baseline in J-ZBI (Japanese- Zarit Caregiver Burden Interview) Total at Week 12 Last Observation Carried Forward (LOCF) |
28.3; 23.2; 26.9; 22.3; -1.3; -0.6 | — |
Summary
Eligibility Criteria
Inclusion criteria
Patients diagnosed as probable Dementia With Lewy Bodies (DLB) according to the diagnostic criteria for DLB.
Participants having caregivers who submit written consent for cooperative involvement in this study, can routinely stay with participants 3 days a week (at least 4 hours a day), provide participants' information necessary for this study, assist treatment compliance, and escort participants on required visits to study institution.
Exclusion criteria
Participants with past experience of donepezil (Aricept) therapy at the same study institution.
Participants treated with donepezil in 3 months immediately before starting the observation period.
Participants with a complication of serious neuropsychiatric disease(s) such as stroke, brain tumor, schizophrenia, epilepsia, normal pressure hydrocephalus, mental retardation, brain trauma with unconsciousness, and/or experience of brain surgery causing unsolved deficiency.
Participants 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
Participants with severe extrapyramidal disorders (Hoehn & Yahr staging score is ≥IV)
Participants whose systolic blood pressure is <90 mmHg or pulse rate is <50 beats/min.
Participants suspected to have a complication of vascular dementia based upon neurological findings.
Data sourced from ClinicalTrials.gov (NCT00543855). 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.