Ponomareva E V, Androsova L V, Krinsky S A, Gavrilova S I
Mental Health Research Center, Moscow, Russia.
Kurchatov Institute, Moscow, Russia.
Zh Nevrol Psikhiatr Im S S Korsakova. 2024;124(4. Vyp. 2):92-99. doi: 10.17116/jnevro202412404292.
To study the efficacy and safety of the use of annual course therapy of choline alfoscerate (CA) as a drug potentially capable of slowing or preventing the transition of amnesic type mild cognitive impairment (aMCI) into clinically pronounced dementia in a three-year open comparative study, as well as to explore the possibility of predicting the preventive effect of such therapy based on a number of clinical and biological parameters.
The study included 100 patients with aMCI, randomly divided into 2 groups: the therapeutic group consisted of 50 patients who received CA course therapy once a year for 3 years (20 intravenous infusions of 1000 mg (4 ml) in 100 ml of saline solution for 4 weeks) and a comparison group of 50 patients who underwent an annual examination at the center and did not receive therapy. Clinical and psychopathological, psychometric, immunological, follow-up, and statistical methods were used.
A comparative three-year prospective study conducted in a group of aMCI patients treated with annual course therapy of CA for 3 years and aMCI patients who did not receive therapy with similar initial demographic, diagnostic, psychometric and immunological characteristics showed a lower progression of cognitive deficits (12.2% and 39.1%, respectively) and a lower conversion rate (8.2% and 26.1%, respectively) to dementia in the therapeutic group compared with the comparison group. The differences between the initial and final (after 1, 2 and 3 years of follow-up) cognitive functioning indicators in the therapeutic group and the comparison group were significant (<0.05) on all scales and tests in favor of the therapeutic group throughout the entire follow-up period.
The results allow us to consider CA as a possible model of preventive dementia therapy aimed at preventing the progression of cognitive deficits and the development of dementia in people at high risk of developing AD - patients with aMCI.
在一项为期三年的开放性对照研究中，研究使用阿法骨化醇胆碱（CA）年度疗程疗法作为一种可能减缓或预防遗忘型轻度认知障碍（aMCI）转变为临床明显痴呆症的药物的疗效和安全性，并探讨基于一系列临床和生物学参数预测这种疗法预防效果的可能性。
该研究纳入了100例aMCI患者，随机分为2组：治疗组由50例患者组成，他们每年接受一次CA疗程治疗，共3年（20次静脉输注1000毫克（4毫升）于100毫升生理盐水中，持续4周）；对照组由50例患者组成，他们在中心接受年度检查但未接受治疗。使用了临床和精神病理学、心理测量学、免疫学、随访及统计学方法。
在一组接受CA年度疗程治疗3年的aMCI患者和一组未接受治疗但具有相似初始人口统计学、诊断、心理测量学和免疫学特征的aMCI患者中进行的为期三年的比较性前瞻性研究显示，与对照组相比，治疗组认知缺陷的进展较低（分别为12.2%和39.1%），痴呆转化率较低（分别为8.2%和26.1%）。在整个随访期间，治疗组和对照组在所有量表和测试中的初始和最终（随访1、2和3年后）认知功能指标差异均有统计学意义（<0.05），有利于治疗组。
这些结果使我们能够将CA视为一种预防性痴呆症治疗的可能模式，旨在预防AD高危人群——aMCI患者认知缺陷的进展和痴呆症的发展。
