Efficacy and clinical significance of choline alfoscerate in pre-dementia cognitive impairment. (A systematic review and meta-analysis of three randomized trials)

Objective. To evaluate the efficacy of choline alfoscerate in mild cognitive impairment through a meta-analysis of randomized clinical trials considering potential sources of bias. Material and methods. A systematic search and meta-analysis were conducted, including three randomized controlled trials of choline alfoscerate as an adjunct to standard therapy for patients with mild to moderate cognitive impairment of vascular, degenerative, or mixed etiology. Quantitative analysis included baseline data (n, M, SD) from the Montreal Cognitive Assessment (MoCA) scale. Effect size was assessed using Cohen’s d with Hedges’ g correction and the unstandardized mean difference (MD) within a random-effects model. Heterogeneity indicators (Q, I2, τ2) and the minimal clinically important difference (MCID) were also calculated. Results. Adding choline alfoscerate to standard therapy significantly increased MoCA scores compared with control groups. In two of the three studies, the effect size surpassed the MCID threshold, indicating clinical significance. Despite high statistical heterogeneity, the effect direction was consistent. The tolerability profile was favorable, as the incidence and pattern of adverse events were comparable to those observed in the control group. Conclusion. The findings of this systematic review and meta-analysis support the hypothesis that choline alfoscerate, as part of medical rehabilitation, is effective in patients with cognitive impairment and underscore the need for further research.