A Phase 2, Placebo-Controlled, Double-Blind Study of E2027 in Subjects With Dementia With Lewy Bodies

A Placebo-Controlled, Double-Blind, Parallel-Group, Randomized, Study To Evaluate the Efficacy, Safety and Tolerability of E2027 in Subjects With Dementia With Lewy Bodies

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223875

Enrollment

182

Registered

2018-04-17

Start date

2018-05-04

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 : E2027 INN of investigational material : Irsenontrine Therapeutic category code : 119 Other agents affecting central nervous system Dosage and Administrat

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Male or female, age 50 to 85 years, inclusive at time of consent -Meet criteria for probable dementia with Lewy bodies (DLB) (as defined by the 4th report of the DLB Consortium). -Must have an identified caregiver or informant who is willing and able to provide follow-up information on the participant throughout the course of the study.

Exclusion criteria

Exclusion criteria: -Any neurological condition that may be contributing to cognitive impairment above and beyond those caused by the participant's DLB, -History of transient ischemic attacks or stroke within 12 months of Screening -Modified Hachinski Ischemic Scale >4 -Parkinsonian (extrapyramidal) features with Hoehn & Yahr stage IV or higher -Any major psychiatric diagnosis,

Design outcomes

Primary

Measure	Time frame
efficacy Montreal Cognitive Assessment (MoCA) Clinician's Interview Based Impression of Change Plus Caregiver Input (CIBIC-Plus)	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics -	—

Countries

Europe, Japan, North America

Outcome results

None listed

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