[Lecanemab and Alzheimer-Perusini's disease: between therapeutic hopes and regulatory challenges]

Alzheimer-Perusini's disease (AD) represents a growing health crisis. The lack of effective disease-modifying treatments and its increasing prevalence in the elderly population contribute to a major burden for patients and their caregivers, challenging health systems globally. The accumulation of beta-amyloid protein (Aβ) within the brain tissue plays an important pathogenic role in the inflammatory and degenerative mechanisms leading to cognitive and functional impairment. In recent years monoclonal antibodies targeting (Aβ) have been developed and one of them (lecanemab) recently received marketing authorization by the European Medicines Agency (Ema). Although they represent an important innovation in the treatment of AD, their clinical net benefit is uncertain, due to modest efficacy and the threat of potentially severe side effects. Cost, mode od delivery and complexity of programs aimed at minimizing risks for people with AD may limit access to these therapies and pose equity issues within health systems.