A multicenter,randomized,double-blind,parallel-group,placebo-controlled study of E2020 in patients with dementia with Lewy bodies(DLB),followed by a long-term extension phase

Status

Unknown

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080221356

Enrollment

141

Registered

2011-01-20

Start date

2011-01-20

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dementia with Lewy bodies

Interventions

investigational material(s) Generic name etc : E2020 INN of investigational material : donepezil hydrochloride Therapeutic category code : 119 Other agents affecting central nervous system Dosage and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)Patients diagnosed as probable DLB according to the diagnostic criteria for DLB 2)Mini-Mental State Examination(MMSE)score is >- 10 and -< 26 3)Patients having caregivers throughout the study who submit written consent to cooperate with this study, can routinely stay with patients 3 days or more a week (at least 4 hours a day), provide patients' information necessary for this study, assist treatment compliance, and escort the patients on required visits to study institution

Exclusion criteria

Exclusion criteria: 1)Patients diagnosed with Parkinson's disease with dementia (PDD) 2)Patients who received anti-dementia drug therapy at the same institution 3)Patients who received anti-dementia drug therapy within 12 weeks before start of Screening 4)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 5)Patients with severe extrapyramidal disorders (Hoehn & Hahr staging score is >- IV) 6)Patients whose systolic blood pressure is < 90 mmHg or pulse rate is < 50/bpm at screening

Design outcomes

Primary

Measure	Time frame
Mini-Mental State Examination (MMSE) Neuropsychiatric Inventory (NPI)	—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026