BACKGROUND Chronic cerebral ischemia (CCI) is a form of cerebrovascular disease manifested as a vascular cognitive impairment (VCI). The management of the patients with CCI is determined by a healthy lifestyle and early therapy aimed at correcting and preventing this disease. Divaza is a drug with endothelial protective and nootropic effects. We present the final efficacy and safety analysis of all-Russian, open-label, prospective, observational, multicenter study of Divaza and emphasize the role of demographic and socioeconomic factors in cognitive disorder (CD) progression. METHODS CCI patients (n = 2,583) with or without CD were enrolled. Patients received Divaza (2 tablets 3 times per day for 12 weeks). Montreal Cognitive Assessment (MoCA) testing was required. The change in the mean MoCA score post-treatment was used as the primary endpoint. As the secondary endpoints, the number of patients with a MoCA <26 and ≤17 (dementia); the percentage of patients with a MoCA score improvement in different age groups; the dynamics of mean MoCA score in age groups; and the relationship between CD and sex or regional social/economic factors were assessed. RESULTS Divaza therapy led to a significant improvement: the mean MoCA score was up to 20% higher post-treatment (Wilcoxon test, p < 0.0001 vs. baseline). The number of participants with MoCA ≥26 increased by 33.6%. The number of patients with dementia was 4.1 times less after therapy (p < 0.00001 vs. baseline). Divaza improved cognitive functions of patients in each age group. Findings demonstrate that regional socioeconomic factors contribute to CD development and severity. The observed divergence between sexes was a result of a larger number of women enrolled. The study confirmed the safety of Divaza. CONCLUSIONS In the study, we observed the efficacy of Divaza for the treatment of CD: a therapy contributed to an increase in the mean MoCA score and the positive dynamics in the number of patients with cognitive improvement.

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认知障碍的治疗和人口因素在疾病进展中的作用：俄罗斯观察计划“DIAMANT”的最终结果

背景技术慢性脑缺血(CCI)是一种表现为血管性认知障碍(VCI)的脑血管疾病。CCI 患者的管理取决于健康的生活方式和旨在纠正和预防该疾病的早期治疗。Divaza 是一种具有内皮保护和促智作用的药物。我们介绍了 Divaza 的全俄罗斯、开放标签、前瞻性、观察性、多中心研究的最终疗效和安全性分析，并强调了人口统计学和社会经济因素在认知障碍 (CD) 进展中的作用。方法 CCI 患者 (n = 2,583) 有或没有 CD。患者接受 Divaza（2 片，每天 3 次，持续 12 周）。需要蒙特利尔认知评估 (MoCA) 测试。治疗后平均 MoCA 评分的变化被用作主要终点。作为次要终点，MoCA<26 且≤17（痴呆）的患者数量；不同年龄组 MoCA 评分改善的患者百分比；年龄组平均 MoCA 得分的动态变化；并且评估了 CD 与性别或区域社会/经济因素之间的关系。结果 Divaza 治疗导致显着改善：平均 MoCA 评分在治疗后高出 20%（Wilcoxon 检验，与基线相比，p < 0.0001）。MoCA ≥26 的参与者数量增加了 33.6%。治疗后痴呆患者的数量减少了 4.1 倍（与基线相比，p < 0.00001）。Divaza 改善了每个年龄组患者的认知功能。结果表明，区域社会经济因素有助于 CD 的发展和严重程度。观察到的性别差异是由于更多的女性入学。该研究证实了 Divaza 的安全性。结论 在该研究中，我们观察了 Divaza 治疗 CD 的疗效：该疗法有助于提高平均 MoCA 评分和认知改善患者数量的积极动态。