Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses.
Potential beneficial effects of masupirdine (SUVN-502) on agitation/aggression and psychosis in patients with moderate Alzheimer's disease: Exploratory post hoc analyses.
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DOI：
10.1002/gps.5813
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发表时间：
2022-10
影响因子：
4
通讯作者：
Cummings, Jeffrey
中科院分区：
文献类型：
--
作者：
Nirogi, Ramakrishna;Jayarajan, Pradeep;Benade, Vijay;Shinde, Anil;Goyal, Vinod Kumar;Jetta, Satish;Ravula, Jyothsna;Abraham, Renny;Grandhi, Venkata Ramalingayya;Subramanian, Ramkumar;Pandey, Santosh Kumar;Badange, Rajesh Kumar;Mohammed, Abdul Rasheed;Jasti, Venkat;Ballard, Clive;Cummings, Jeffrey
探讨马苏匹定对神经精神症状的影响。我们评估了Masupirdine （SUVN‐502）对中度AD患者认知功能的影响。预先设定的主要结局没有显示药物-安慰剂的差异。对12项神经精神量表的领域进行事后分析。在一个亚组患者中(安慰剂，n = 57；马苏匹定50 mg， n = 53；masupirdine 100毫克,n = 48)与基线风潮/侵略症状≥1,显著减少搅拌/攻击得分在masupirdine 50毫克(95%可信区间(CI), 1.9−−0.5,p < 0.001)和masupirdine 100毫克(95% CI, 1.7−−0.3,p = 0.007)治疗手臂在13周相比安慰剂和试验的效果持续时间的26周masupirdine 50 mg治疗手臂(95% CI, 2.3−−0.8,p < 0.001)。在基线激动/攻击症状≥3的患者亚组（安慰剂组，n = 29；马苏匹定50 mg， n = 30；马苏匹定100 mg， n = 21）中也有类似的观察结果。子群的病人(安慰剂,n = 28; masupirdine 50毫克,n = 28; masupirdine 100毫克,n = 28)曾基线精神病症状和/或症状出现,显著减少精神病分数masupirdine中可观察到50毫克(4周:95%可信区间,2.8−−1.4,p < 0.001; 13周:95%可信区间,3.3−−1.3,p < 0.001)和masupirdine 100毫克(4周:95%可信区间,1.4−为0,p = 0.046; 13周:95%可信区间,1.9−0.1,p = 0.073)相比安慰剂治疗武器。需要进一步研究马苏匹定对NPS的潜在有益作用。阿尔茨海默病（AD）是一种神经退行性疾病，表现为认知能力下降、功能障碍和神经精神症状（NPS），对NPS的安全有效治疗有大量未满足的需求。事后分析表明，马苏匹定显著减少AD亚组患者的躁动/攻击和精神病。Masupirdine正在一项治疗AD型痴呆患者躁动/攻击的3期试验中进行评估。
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. Alzheimer's disease (AD) is a neurodegenerative disorder with manifestations of cognitive decline, functional impairment, and neuropsychiatric symptoms (NPS), with massive unmet need for the safe and effective treatment of NPS. Post hoc analyses suggested masupirdine significantly reduced agitation/aggression, and psychosis in subgroup of patients with AD. Masupirdine is being evaluated in a phase‐3 trial for the treatment of agitation/aggression in patients with AD type dementia.
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