Donanemab eligibility in early Alzheimer's disease: A real-world study

This study evaluates the real-world eligibility of patients with early Alzheimer's disease (AD) for donanemab, a monoclonal antibody targeting amyloid plaques. At a tertiary center in Italy, 408 patients with mild cognitive impairment (MCI) or mild AD were assessed against clinical trial criteria. While 41% were amyloid-positive, only 10.05% met eligibility for treatment, primarily due to exclusions for amyloid biomarkers, medical conditions, and MRI findings. These results highlight the gap between trial populations and real-world patients. Balancing efficacy with safety remains a key challenge in expanding access to anti-AD immunotherapy like donanemab in routine clinical practice.