Prospekta

Objective. To conduct a meta-analysis of randomized controlled trials (RCTs) to evaluate the efficacy of Prospekta in the treatment of SCI of varying severity. Material and methods. The meta-analysis included the results of RCTs of the efficacy of Prospekta in the treatment of VCI, the severity of which was assessed using the Montreal Cognitive Scale (MoCA). The pooled effect estimate included all publications of double-blind, placebo-controlled RCTs that provided sufficient MoCA efficacy data to support further statistical analysis. The main result of the meta-analysis was obtained for the final values of the efficacy indicator in the groups of patients receiving the drug Prospekta, in comparison with the placebo group. Results. A meta-analysis of the effectiveness of Prospekta in the treatment of SCI of varying severity was carried out based on data from 3 RCTs and 2 CTs involving 12.701 patients aged 18 years and older. When using the mixed models method, the effect size for the endpoint «change in total MoCA score from baseline to follow-up visit» was 3.4 points for Prospekta (2.7 points for placebo, p<0.0001); for the end point «∆ between changes in the total score on the MoCA scale while taking Prospekta and placebo» — 0.6736 points (p<0.0001). Conclusion. A statistically significant improvement in cognitive function according to the MoCA scale was demonstrated in patients with VCI using the drug Prospekta.

General toxic effect of the drug Prospekta (modified affinity purified antibodies to the brain-specific S100 protein) was studied on mature male and female mice and rats: acute toxicity with double intragastric and intraperitoneal administration of the maximum permissible doses at a 2-h interval, repeated dose toxicity with intragastric administration of the maximum permissible and close to therapeutic doses for 6 months. No lethal and toxic effects on animals were observed, including no toxic effects on vital systems, i.e., CNS and cardiovascular system, as well systems with the functions that may be temporarily disrupted (excretory and digestive systems). All the differences between animals of the experimental and control groups varied within the physiological range. It can be concluded that the drug produces no general toxic effect on laboratory animals.