Phase 2 study of zervimesine (CT1812) in participants with mild‐to‐moderate dementia with Lewy bodies (DLB)

INTRODUCTION: Zervimesine is in clinical development for Alzheimer's disease and dementia with Lewy bodies (DLB). This Phase 2a study evaluated zervimesine in participants with mild-to-moderate DLB. METHODS: This was a multi-center, double-blind, placebo-controlled, parallel-design study. Participants aged 50 to 85 years, with probable DLB, a Mini-Mental State Examination score of 18 to 27, and without neurological co-morbidities were randomized to zervimesine 100 mg, zervimesine 300 mg, or placebo for 26 weeks to assess safety and efficacy. RESULTS: Of 293 participants screened, 130 were randomized, and 109 (83.8%) completed the study. Baseline characteristics were similar between groups. Discontinuation rates for adverse events were 4.5% for zervimesine 100 mg, 16.3% for zervimesine 300 mg, and 4.8% for placebo. DISCUSSION: This study demonstrated that zervimesine was safe and well tolerated. The favorable efficacy profile from exploratory outcomes provides a rationale for testing zervimesine in larger studies. This study was registered at ClinicalTrials.gov: NCT05225415. HIGHLIGHTS: This study evaluated the safety and efficacy of zervimesine in Lewy body dementia. The incidence of adverse events was comparable to zervimesine 100 mg and placebo. Favorable, consistent trends were observed with zervimesine for exploratory endpoints.