THE FIRST DISEASE-MODIFYING TREATMENT FOR ALZHEIMER’S DISEASE. THE DAWN OF A NEW ERA

Abstract

After almost 20 years, a new drug for Alzheimer’s disease, the anti-amyloid monoclonal antibody aducanumab, was approved in the USA by the FDA under the accelerated approval pathway. The consideration of brain amyloid reduction as a surrogate end point indicating efficacy, indications and contraindications (disease stage, verification of the diagnosis, comorbidities, cerebral amyloid angiopathy), the need for a post-approval trial to verify the clinical benefits and financial issues (cost-effectiveness), all triggered discussions and debates worldwide. Despite controversies, this is the first disease-modifying treatment for Alzheimer’s disease targeting one of the main neurochemical aspects of the disease and being a step forward in the treatment of this devastating disease. Patients and caregivers should be informed about the potential benefits and side-effects of the treatment, in order to avoid non-realistic expectations about this new treatment.