Potential beneficial effects of masupirdine (SUVN‐502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses

OBJECTIVES: The effects of masupirdine on the neuropsychiatric symptoms were explored. METHODS: Masupirdine (SUVN‐502) was evaluated for its effects on cognition in patients with moderate AD. The prespecified primary outcome showed no drug‐placebo difference. Post hoc analyses of domains of the 12‐item neuropsychiatric inventory scale were carried out. RESULTS: In a subgroup of patients (placebo, n = 57; masupirdine 50 mg, n = 53; masupirdine 100 mg, n = 48) with baseline agitation/aggression symptoms ≥1, a statistically significant reduction in agitation/aggression scores was observed in masupirdine 50 mg (95% confidence interval (CI), −1.9 to −0.5, p < 0.001) and masupirdine 100 mg (95% CI, −1.7 to −0.3, p = 0.007) treated arms at Week 13 in comparison to placebo and the effect was sustained for trial duration of 26 weeks in the masupirdine 50 mg treatment arm (95% CI, −2.3 to −0.8, p < 0.001). Similar observations were noted in the subgroup of patients (placebo, n = 29; masupirdine 50 mg, n = 30; masupirdine 100 mg, n = 21) with baseline agitation/aggression symptoms ≥3. In the subgroup of patients (placebo, n = 28; masupirdine 50 mg, n = 28; masupirdine 100 mg, n = 28) who had baseline psychosis symptoms and/or symptom emergence, a significant reduction in psychosis scores was observed in the masupirdine 50 mg (Week 4: 95% CI, −2.8 to −1.4, p < 0.001; Week 13: 95% CI, −3.3 to −1.3, p < 0.001) and masupirdine 100 mg (Week 4: 95% CI, −1.4 to 0, p = 0.046; Week 13: 95% CI, −1.9 to 0.1, p = 0.073) treatment arms in comparison to placebo. CONCLUSION: Further research is warranted to explore the potential beneficial effects of masupirdine on NPS.