Donanemab and the Future of Alzheimer’s Treatment: Between Innovation and Caution

Introduction and Objective: Alzheimer’s disease (AD) is the leading cause of dementia, mainly affecting people over 65. Its growing prevalence, driven by population aging, highlights the need for disease-modifying therapies. This article reviews donanemab - a monoclonal antibody targeting β-amyloid plaques - with emphasis on efficacy, safety, and regulatory landscape. State of Knowledge: Donanemab may slow cognitive decline in early AD, especially in patients with low-to-intermediate tau levels. Clinical trials showed a 35% reduction in disease progression. However, the treatment is associated with amyloid-related imaging abnormalities (ARIA), particularly in APOE ε4 carriers. Conclusions: Donanemab offers meaningful clinical benefits in early AD, but safety concerns and inconsistent regulatory decisions complicate its implementation. Though approved in the U.S., Japan, and China, it was denied EMA authorization due to ARIA risks. In Poland, access is limited to individual cases via the Named Patient Import Scheme. Its future use will require precise patient selection and continued safety monitoring. The case of donanemab illustrates the broader tension between therapeutic innovation and patient protection.