[Anti-amyloid antibodies against Alzheimer's disease : Lecanemab and donanemab in practice-Clinical importance, patient selection and safety management].

Abstract

Lecanemab and donanemab are the first disease-modifying therapies for early Alzheimer's disease. These humanized IgG1 antibodies promote the clearance of aggregated amyloid-beta peptides and, in the pivotal CLARITY AD and TRAILBLAZER-ALZ 2 trials, significantly delayed cognitive and functional decline, with an approximately 30% relative risk reduction for the clinical stage progression; however, the clinical meaningfulness remains contested: critics point to the small between-group difference in relation to the total score. This is weighed against the first disease-modifying effect and the first pharmacotherapy for mild cognitive impairment due to Alzheimer's disease. A prerequisite is the biological diagnosis: the reference standard is cerebrospinal fluid (CSF) and amyloid positron emission tomography (PET), potentially complemented in the future by blood biomarkers such as plasma p‑Tau217. Amyloid-related imaging abnormalities (ARIA) are the key adverse event, manageable through patient selection, ApoE-ε4 genotyping and magnetic resonance imaging (MRI) monitoring. The indications and follow-up belong in specialized centers.