Efficacy and safety profiles of monoclonal antibodies used in the therapy of Alzheimer’s disease

Introduction: Advances in molecular biology and biotechnology in recent decades have led to creation of new therapeutic strategies for Alzheimer’s disease (AD) patients. Among the emerging therapeutic approaches, monoclonal antibodies are attracting particular attention due to their ability to modulate the accumulation of amyloid plaques and tau protein in the brain, thus proposing promising pathogenetic approach. Aim: to summarize efficacy, side effects and mortality rates of monoclonal antibodies based on the results of clinical trials in comparison with conventional therapy. Methods: All registered clinical studies related to AD treatment using monoclonal antibodies were found in ClinicalTrials.gov database. The information on adverse effects was obtained from the articles related to the third phase clinical studies, with total 21 articles included in the analysis. Data on conventional therapy were retrieved from clinical guidelines related to AD treatment. Results: We found that the number of significant side effects and mortality varies significantly for different monoclonal antibodies. For the most part, side effects are not specific to the drugs used, and therefore it is not possible to assess the direct effect of the drug on the development of certain adverse events, as well as to adequately compare the safety of different drugs, due to different mechanisms of action and recommended doses. Magnetic resonance imaging with estimation of amyloid-related imaging abnormalities changes is the most promising method for antibodies comparison, but this approach still lacks correlation with clinical course. Also, it is recommended to separately consider the side effects associated with infusion. Conclusion: The use of pathogenetic antibody therapy will improve the quality of AD treatment in the future. However, up to date, there are no unified protocols for estimation of drug effectiveness and its comparison. Evaluation of side effects and determination of antibody-specific side effects is necessary to improve the safety of treatment of patients with AD.