Possibilities nootropic drugs in non-demented patients with vascular cognitive disorders

Objective: to study the clinical efficacy and tolerability of omberacetam in comparison with piracetam/cinnarizine and aminophenylbutyric acid in non-demented patients with vascular cognitive impairment (VCI).

Patients and methods. The study included 150 patients with VCI that does not meet dementia, randomized into three groups of 50 patients. In addition to the basis therapy, patients of the 1st group recieved omberacetam 10 mg 2 times per day, the 2nd group – piracetam/cinnarizine 400/25 mg (1 tablet) 3 times per day, the 3rd group – aminophenylbutyric acid 250 mg 3 times per day. The duration of the treatment course was 45 days. In 50 patients of the 1st group and another 50 patients with VCI from other groups, the duration of the nootropic effect of omberacetam was evaluated 3.5 months after the end of follow-up. Cognitive functions and emotional state of patients were assessed using: 1) Montreal Cognitive Assessment (MoCA); 2) Hamilton Anxiety Rating Scale (HAM-A); 3) Subjective assessment of asthenia scale; 4) Modified subjective sleep characteristics scale. Evaluation of treatment effectiveness and tolerability was carried out.

Results and discussion. During omberacetam treatment a significant improvement in well-being and regression of patient complaints were observed. After 45 days of therapy an increase in the mean MoCA score from 19.8 to 23.3 points (p≥0.001) was observed in the omberacetam group. In other groups, an increase in the mean MoCA score was also noted, but it was less significant. A decrease in asthenic symptoms, anxiety, and dissomnic disorders was present in all studied groups. Anxiety level, assessed by the HAM-A, decreased by 16.9; 19.9 and 20.0 points (p≥0.001) in groups 1, 2 and 3, respectively. Sleep characteristics, assessed by the subjective sleep characteristics scale, improved by 4.6; 5.0 and 5.3 points (p≥0.001), respectively. 4.5 months after the completion of the omberacetam treatment course, the mean MoCA score was 0.8 points higher compared to baseline (p=0.061).

Conclusion. The results showed high efficacy and safety of omberacetam in patients with VCI. A long-term positive effect of omberacetam was observed.

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