[Efficacy and safety of the drug Cellex for the treatment of patients with cognitive impairment with chronic cerebral ischemia - results of a multicenter randomized double-blind placebo-controlled clinical trial].

Abstract

OBJECTIVE To evaluate the efficacy and safety of using Cellex for the treatment of cognitive impairment as part of the complex therapy of patients with chronic cerebral ischemia (CCI) compared with placebo. MATERIAL AND METHODS The study randomized 300 patients with a reliable diagnosis of CCI stage 1-2, all participants were divided into two groups, 150 participants in each - main and control. The study drug Cellex or placebo was administered as two 10-day treatment courses, 1 ml once a day. The duration of the study was 90±5 days for each participant. The primary end point for evaluating the effectiveness of the therapy was the degree of improvement in the state of cognitive functions relative to the initial state according to the Montreal Cognitive Dysfunction Scale (MoCA) on the 31st and 60th days from the start of therapy in the compared groups. Secondary endpoints were the assessment of the degree of improvement in the state of cognitive functions according to psychometric testing scales (MoCA, Correction Test, Frontal Dysfunction Test Battery) relative to the initial state on the 31st, 60th and 90th days from the start of therapy. Also, a dynamic assessment of the systemic concentration of markers of brain damage - S100β, GFAP, MMP9 and neurotrophins - BDNF and GDNF was carried out. RESULTS The primary endpoint of the study was achieved-the MoCA score in each group increased uniformly after baseline. However, in the main group, this indicator was significantly higher starting from visit 3 - 23.4±2.8 points in the main group, in the placebo group 22.7±2.3 (p<0.001), a statistically significant difference also remained at visit 5 (p<0.001). When analyzing the secondary endpoints according to the battery of frontal dysfunction tests and the correction test, a more pronounced positive trend was also noted in the main group. Changes in the emotional sphere in both groups remained within the normal range. The dynamics of the systemic concentration of markers of brain damage and neurotrophins was multidirectional, the assessment of which was possible only at the trend level. CONCLUSION Based on the statistical analysis of the results of the study, Cellex was confirmed to be superior to Placebo in the degree of improvement in cognitive functions measured by the MoCA scale after the 1st and 2nd treatment courses.