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INTRODUCTION In spite of the steady progress in the understanding of the etiopathogenesis of Alzheimer's disease (AD) for the last 50 years, exceptionally few long-standing drugs are at present used for AD therapy. New interventions that either prevent, slow or stop the disease are urgently warranted to overcome the growing AD burden. AIMS The aim of this narrative review is to summarize the currently existing preclinical and clinical evidence regarding new drug development and biomarkers for better understanding and focused management of