Certain aspects of the methodology of conducting clinical trials of drugs for the treatment of Alzheimer’s disease

   Introduction. Dementia is a heterogeneous class of diseases, the individual subtypes of which are distinguished based on etiological factors, the nature of disorders, the course of dementia, as well as laboratory instruments and neuroimaging. Among the diseases whose leading clinical syndrome is dementia, Alzheimer's disease (AD), vascular dementia, dementia with Lewy bodies, Pick's disease, Creutzfeldt-Jakob disease, Huntington's chorea, Parkinson's disease, the effects of traumatic brain injury, brain tumor, dementia with substance abuse and other diseases. Currently, there is no treatment that could significantly slow down or stop the effects of AD on the brain, and the search continues for ways to improve the treatment of AD. The search for effective and safety drugs for the treatment of AD is an extremely important task, which determines the urgency of developing new drugs for its treatment. Proper program planning and clinical trials are necessary to obtain reliable data on the efficacy and safety of drugs. Currently, there are no documents in the Russian Federation (RF) and the Eurasian Economic Union (EEU) regulating the conduct of clinical trials of drugs used to treat AD.

   Objective. The aim of this study was to analyze regulatory approaches to planning clinical research programs for drugs used for AD treatment abroad and to assess the possibility of extrapolation to RF clinical practice in the development of drugs for AD treatment.

   Discussion. The strategy for conducting clinical trials of drugs and the requirements for data volume and quality regarding efficacy and safety are presented. This article was prepared on the basis of recommendations approved by the RF for the planning and development of medicines, guidelines for the examination of drugs, EU regulatory requirements, and documents from the International Council for the Harmonization of Technical Requirements for the Registration of Medicines for Medical Use (ICH).

   Conclusion. An analysis of the Guidelines of the European Medicines Agency (EMA), which regulate the basic principles and key aspects of conducting preclinical and clinical trials on drugs for the treatment of AD, was carried out. The provisions of the EMA guidelines can be used as a basis for developing drug research programmes for treating diseases. It is advisable to develop a national guideline for the study of drugs for AD treatment in accordance with the regulatory legal acts in force in the RF.

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