Treatment of cognitive impairment in patients with cerebral infarction in the internal carotid arteries circulation system: results of a multicentre, randomized, double-blind, placebo-controlled clinical trial

Abstract

Objective: to evaluate the efficacy and safety of the Prospecta drug in the treatment of cognitive impairment (CI) in patients with ischemic stroke (IS) in the carotid vascular territory.Material and methods. The double-blind, placebo-controlled, randomized clinical trial enrolled 246 patients aged 40 to 75 years with IS in the carotid vascular territory within 72 hours of stroke onset, moderate CI (<26 points on the Montreal Cognitive Assessment, MoCA), full consciousness (15 points on the Glasgow Coma Scale), moderate severity of stroke (8–12 points on the National Institute of Health Stroke Scale, NIHSS), moderate impairment of activity (2–3 points on the – Modified Rankin Scale, mRs). At visit 1, complaints and medical history were collected, vital signs (VS) and laboratory parameters were recorded, CI was assessed according to MoCA and the Glasgow Coma Scale, NIHSS and mRs were filled out. Patients were randomized into two groups: in the first group they received Prospecta for 90 days, in the second group placebo (PL) following a similar regimen. The groups were comparable in terms of demographic and baseline clinical characteristics. After 90 days, complaints, medical history, VS, laboratory parameters and assessment of CI according to MoCA were recorded, and NIHSS and mRs questionnaires were filled out again. The intention-to-treat (ITT) efficacy analysis was performed based on the results of the treatment and follow-up of the Full analysis set (FAS), which comprised 241 patients (122 patients in the Prospecta group and 119 patients in the PL group; 4 patients were excluded from the ITT analysis because they were erroneously included in the study). The results of the per-protocol (PP) analysis are shown in square brackets.Results. The 90-day use of Prospecta reduced the severity of CI in patients with carotid IS compared with placebo therapy. MoCA scale scores increased from 20.7±3.5 [20.9±3.0] to 24.6±2.9 [25.2±2.5] points in the Prospecta group and from 21.7±2.4 [21.6±2.4] to 24.5±3.0 [24.8±2.8] points in the PL group (p=0.0006 [p=0.0014]). 42 adverse events (AEs) were recorded in 32 (26.0%) patients in the Prospecta group and 37 AEs in 28 (23.0%) patients in the PL group (p=0.656). All AEs in the Prospecta group were not significantly related to the use of the drug. No deaths or recurrent IS were recorded.Conclusion. Prospecta is an effective and safe treatment for CI in patients with carotid IS