探讨了masupirdine对神经精神症状的影响。
评估了Masupirdine(SUVN-502)对中度AD患者认知功能的影响。预设的主要结果没有显示药物-安慰剂差异。对12项神经精神量表的领域进行了事后分析。
在一组患者中(安慰剂,n=57;马苏普丁50毫克,n=53;马苏普丁100毫克,n=48),基线躁动/攻击症状≥1,在masupirdine50mg中观察到躁动/攻击评分的统计学显着降低(95%置信区间(CI),与安慰剂相比,在第13周,-1.9至-0.5,p<0.001)和马苏普丁100mg(95%CI,-1.7至-0.3,p=0.007)治疗组,并且在马苏普丁50mg治疗组(95%CI,-2.3至-0.8,p<0.001)。在患者亚组中也观察到了类似的观察结果(安慰剂,n=29;马苏普丁50毫克,n=30;马苏普丁100毫克,n=21),基线躁动/攻击症状≥3。在患者亚组(安慰剂,n=28;masupirdine50毫克,n=28;马苏普丁100毫克,n=28)有基线精神病症状和/或症状出现的人,与安慰剂组相比,在masupirdine50mg(第4周:95%CI,-2.8~-1.4,p<0.001;第13周:95%CI,-3.3~-1.3,p<0.001)和masupirdine100mg(第4周:95%CI,-1.4~0,p=0.046;第13周:95%CI,-1.9~
需要进一步的研究来探索马苏普丁对NPS的潜在有益作用。
The effects of masupirdine on the neuropsychiatric symptoms were explored.
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.
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.
Further research is warranted to explore the potential beneficial effects of masupirdine on NPS.