Gavrilova S I, Kolykhalov I V, Mikhaylova N M, Ponomareva E V, Fedorova Ya B, Medvedev V E, Frolova V I, Gushanskaya E V, Litvinenko I V, Emelin A Yu, Lobzin V Yu, Kashin A V, Tanashyan M M, Kachanova M V, Knyazev A V, Gonik M I
Mental Health Research Center, Moscow, Russia.
Patrice Lumumba Peoples' Friendship University of Russia, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(2):69-77. doi: 10.17116/jnevro202412402169.
Evaluation of the efficacy and safety of the drug Acatinol Memantine, 20 mg (once daily) in comparison with the drug Acatinol Memantine, 10 mg (twice daily) in patients with moderate to moderate severe vascular dementia.
The study included 130 patients aged 50-85 years of both sexes with instrumentally and clinically confirmed vascular dementia. The patients were randomized into 2 groups. Group I consisted of 65 patients receiving Akatinol Memantine, 20 mg once daily, group II - 65 patients receiving Akatinol Memantine, 10 mg twice daily for 24 weeks. Clinical, parametric and statistical research methods were used. The Alzheimer's disease assessment scale, the cognitive subscale (ADAS-cog), the short mental Status Assessment Scale (MMSE) and the general clinical impression scale for patients condition and illness severity (CGI-C and CGI-S) and the Hamilton Depression Rating scale (HAM-D) were used. Adverse events were collected and analyzed.
At week 24, both groups showed statistically significant positive change in ADAS-cog total score: in group I the total score was 27.2±8.76 points (absolute difference from baseline 3.5 points; <0.01), and in group II - 26.1±7.86 points (absolute difference from baseline 2.5 points; <0.01) with no statistically significant differences between groups. Evaluation of secondary efficacy criteria (change in ADAS-cog total score at week 12 and MMSE at weeks 4, 12, and 24) also revealed statistically significant benefit in both groups compared to baseline with no significant differences between groups. Statistically significant improvement was noticed on CGI-S and CGI-C scales in both groups. Akatinol Memantine was safe and well tolerated in both groups.
The study showed no lesser efficacy and safety of Akatinol Memantine, 20 mg (once daily) compared to Akatinol Memantine, 10 mg (twice daily) in patients with moderate and moderately severe vascular dementia.
评估20毫克（每日一次）阿卡替尼美金刚药物与10毫克（每日两次）阿卡替尼美金刚药物在中度至中度重度血管性痴呆患者中的疗效和安全性。
该研究纳入了130名年龄在50 - 85岁之间、经仪器检查和临床确诊为血管性痴呆的男女患者。患者被随机分为两组。第一组由65名接受每日一次20毫克阿卡替尼美金刚的患者组成，第二组由65名接受每日两次10毫克阿卡替尼美金刚的患者组成，为期24周。采用了临床、参数和统计研究方法。使用了阿尔茨海默病评估量表、认知子量表（ADAS - cog）、简易精神状态评估量表（MMSE）、患者病情和疾病严重程度的总体临床印象量表（CGI - C和CGI - S）以及汉密尔顿抑郁量表（HAM - D）。收集并分析不良事件。
在第24周时，两组ADAS - cog总分均显示出具有统计学意义的正向变化：第一组总分是27.2±8.76分（与基线的绝对差值为3.5分；<0.01），第二组为26.1±7.86分（与基线的绝对差值为2.5分；<0.01），两组之间无统计学显著差异。对次要疗效标准（第12周时ADAS - cog总分的变化以及第4、12和24周时MMSE的变化）的评估也显示，与基线相比，两组均有统计学显著益处，且两组之间无显著差异。两组在CGI - S和CGI - C量表上均有统计学显著改善。两组中阿卡替尼美金刚均安全且耐受性良好。
该研究表明，在中度和中度重度血管性痴呆患者中，20毫克（每日一次）阿卡替尼美金刚与10毫克（每日两次）阿卡替尼美金刚相比，疗效和安全性并不逊色。
