Study To Evaluate the Efficacy, Safety and Tolerability of E2027 (Hereinafter Referred to as Irsenontrine) in Participants With Dementia With Lewy Bodies

Phase 2 Completed 326 enrolled Eisai Inc.

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study will be conducted to compare Irsenontrine to placebo on the cognitive endpoint of Montreal Cognitive Assessment (MoCA) and the global clinical endpoint of Clinician's Interview Based Impression of Change Plus (CIBIC-Plus) Caregiver Input in participants with dementia with Lewy bodies after 12 weeks of treatment.

Timeline

Start: 2018-05-04
Primary completion: 2020-04-15
Completion: 2020-04-15

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs Irsenontrine 50 mg; p = 0.6909; MMRM NCT03467152 ↗

registry analysis (superiority test); Placebo vs Irsenontrine 50 mg; p = 0.8251; Odds Ratio (OR) 1.018 (95% CI 0.695 to 1.492); GLMM NCT03467152 ↗

Publications

Oosthoek M, In 't Veld SGJG, Vermunt L, Ye Y, van Ingen M, Koel-Simmelink M, Vijverberg EGB, Saxena S, Hersch S, Irizarry M, Sachdev P, Teunissen CE. Effects of the novel phosphodiesterase 9 inhibitor irsenontrine on CSF proteomics profile in Abeta+ and Abeta- dementia with Lewy bodies patients. Alzheimers Res Ther. 2026 Apr 24;18(1):139. doi: 10.1186/s13195-026-02065-w.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Irsenontrine	Small molecule	50 mg	Oral