Clinical Efficacy of Omberacetam in Adults with Cognitive Impairment: A Systematic Review
TL;DR
The available clinical evidence indicates that omberacetam is effective in improving cognitive function in adults with non-dementia cognitive impairment and has a favorable safety profile, however, the predominance of open-label study designs highlights the need for further randomized, placebo-controlled trials with standardized cognitive endpoints.
Abstract
Background
. Cognitive impairment in older adults is a leading cause of functional decline and reduced quality of life, and it is driven by a combination of vascular, metabolic, and stress-related mechanisms. Omberacetam (Noopept) is a nootropic agent with a multimodal mechanism of action, whose clinical efficacy and safety have been evaluated in multiple studies. However, the available evidence has not been systematically summarized.
Objective
. To conduct a systematic review of clinical studies assessing the efficacy and safety of omeprazole in adults with cognitive impairment due to various etiologies, including non-dementia.
Methods
. This systematic review was conducted in accordance with the PRISMA-2020 guidelines. Literature searches were conducted using PubMed/MEDLINE, eLIBRARY.RU and manual searches of relevant Russian medical journals. Clinical studies involving adult patients who were treated with omberacetam at therapeutic doses and reported quantitative cognitive outcomes or safety data were included in the analysis. Risk of bias was assessed using the Cochrane Risk of Bias criteria. Due to the methodological and clinical heterogeneity of the studies, a metaanalysis was not conducted; results were analyzed qualitatively.
Results
. Eighteen clinical studies involving 1,279 patients were included, of whom 988 received omberacetam. The main clinical populations comprised vascular cognitive impairment, dyscirculatory encephalopathy, mild cognitive impairment, post-stroke, and post-traumatic cognitive disorders. Across all studies, omberacetam treatment was associated with improvement in cognitive performance assessed by global cognitive scales (MMSE, MoCA) and domain-specific neuropsychological tests. Improvements in MMSE scores ranged from +0.6 to +3.5 points depending on patient population and treatment duration. In comparative studies, omberacetam demonstrated efficacy comparable to or greater than piracetam and standard therapy. The drug showed a favorable tolerability profile; adverse events were generally mild, transient, and rarely led to treatment discontinuation.
Conclusions
. The available clinical evidence indicates that omberacetam is effective in improving cognitive function in adults with non-dementia cognitive impairment and has a favorable safety profile. However, the predominance of open-label study designs highlights the need for further randomized, placebo-controlled trials with standardized cognitive endpoints.