This study investigated the effects of vortioxetine on cognitive function in adults with mild cognitive impairment (MCI). This single-arm, open-label, phase II study enrolled 111 adults with MCI without depressive symptoms to receive 5-10 mg/day vortioxetine for 6 months. Main outcomes assessed: cognitive function [Montreal Cognitive Assessment (MoCA); Digit Symbol Substitution Test (DSST)], disease severity [Clinical Dementia Rating (CDR)], clinician-assessed improvement and safety. Mean MoCA score increased from 24.2 points (baseline) to 29.7 points (month 6), placing most subjects within the cognitively normal range (≥26 points). Compared with baseline, MoCA and DSST scores were significantly improved at months 1, 3 and 6 (P < 0.001 for all). Global CDR scores significantly improved from baseline to month 6 (mean change -0.37 points; P < 0.001), representing an improvement from very mild impairment (0.50 points) to cognitively normal status (0.13 points), mainly in CDR memory scores. At month 6, 89.6% of subjects had improved disease severity. Adverse events and adverse drug reactions were reported in 9.9% (n = 11) and 2.7% (n = 3) of subjects, respectively. Vortioxetine treatment was associated with significant improvement in cognitive function and a favorable safety profile in community-dwelling older adults with MCI. Given the lack of evidence for efficacious pharmacologic interventions for MCI, our results are encouraging and warrant further investigation.

中文翻译：

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沃替西汀改善轻度认知障碍的认知。

本研究调查了沃替西汀对轻度认知障碍 (MCI) 成人认知功能的影响。这项单臂、开放标签、II 期研究招募了 111 名没有抑郁症状的 MCI 成人，接受 5-10 毫克/天的沃替西汀治疗 6 个月。评估的主要结果：认知功能 [蒙特利尔认知评估 (MoCA); 数字符号替换测试 (DSST)]、疾病严重程度 [临床痴呆评分 (CDR)]、临床医生评估的改善和安全性。平均 MoCA 得分从 24.2 分（基线）增加到 29.7 分（第 6 个月），使大多数受试者处于认知正常范围内（≥26 分）。与基线相比，MoCA 和 DSST 评分在第 1、3 和 6 个月显着改善（所有 P < 0.001）。全球 CDR 评分从基线到第 6 个月显着改善（平均变化 -0.37 分；P < 0.001），代表从非常轻微的损伤（0.50 分）到认知正常状态（0.13 分）的改善，主要是在 CDR 记忆评分方面。在第 6 个月，89.6% 的受试者疾病严重程度有所改善。分别有 9.9% (n = 11) 和 2.7% (n = 3) 的受试者报告了不良事件和药物不良反应。沃替西汀治疗与 MCI 社区老年人的认知功能显着改善和良好的安全性相关。鉴于缺乏 MCI 有效药物干预的证据，我们的结果令人鼓舞，值得进一步调查。分别有 9.9% (n = 11) 和 2.7% (n = 3) 的受试者报告了不良事件和药物不良反应。沃替西汀治疗与 MCI 社区老年人的认知功能显着改善和良好的安全性相关。鉴于缺乏 MCI 有效药物干预的证据，我们的结果令人鼓舞，值得进一步调查。分别有 9.9% (n = 11) 和 2.7% (n = 3) 的受试者报告了不良事件和药物不良反应。沃替西汀治疗与 MCI 社区老年人的认知功能显着改善和良好的安全性相关。鉴于缺乏 MCI 有效药物干预的证据，我们的结果令人鼓舞，值得进一步调查。