Abstract
The phase 2 ERUDITE (NCT05182476) study evaluated the efficacy and safety of luvadaxistat, a selective ᴅ-amino acid oxidase inhibitor, for cognitive impairment associated with schizophrenia. ERUDITE was a randomized, double-blind, placebo-controlled, parallel-group study in adults with schizophrenia receiving background antipsychotic therapy. Following a 2-week placebo run-in, participants were randomized 2:1:1 to receive placebo, luvadaxistat 20 mg, or luvadaxistat 50 mg once daily for a 12-week treatment period. The primary endpoint was change from baseline to Day 98 in the Brief Assessment of Cognition in Schizophrenia (BACS) composite score. Safety outcomes included the incidence of treatment-emergent adverse events (TEAEs). Overall, 203 participants were randomized (placebo, n = 101; luvadaxistat 20 mg, n = 50; luvadaxistat 50 mg, n = 52), and 178 (87.7%) completed the treatment period. Luvadaxistat did not significantly improve performance (change from baseline) in BACS composite score versus placebo at Day 98 (least-squares mean difference [95% confidence interval]: 20 mg, -0.7 [-2.8, 1.4], p = 0.75; 50 mg, -0.5 [-2.7, 1.6], p = 0.69). TEAEs were reported in approximately one-third of participants across groups, with comparable rates observed between the luvadaxistat and placebo groups. TEAEs were mostly mild or moderate, and no safety concerns were identified. Luvadaxistat 20 mg or 50 mg did not show statistically significant changes in cognitive performance or functioning within the ERUDITE study. Trial registration: ClinicalTrials.gov identifier NCT05182476.