Estimating anti-amyloid therapy eligibility in Alzheimer's disease: A real-world retrospective study from an Italian memory clinic.

Abstract

BackgroundAmyloid-targeting therapies (ATTs) such as donanemab may change the management of Alzheimer's disease (AD). However, ATTs require meticulous eligibility assessment to optimize the benefit-to-risk ratio.ObjectiveTo quantify the proportion of patients eligible for donanemab in a real-world Italian memory clinic, and to assess how this proportion changes under stricter biological criteria.MethodsIn this real-world study, we retrospectively evaluated consecutive patients with new-onset cognitive symptoms at the Fondazione Policlinico Campus Bio-Medico between October 2024 and March 2026. Amyloid status was determined by cerebrospinal fluid (CSF) examination or PET-imaging. Eligibility was determined using European Medicines Agency and Appropriate Use Recommendations (AUR).ResultsWe included 179 consecutive patients (mean age 72.3 ± 7.2 years, 77 [44.0%] female) with mean Mini-Mental State Examination score 26.4 ± 3.3. A clinical diagnosis of AD was made in 78 (43.6%), and 46 (25.7%) were amyloid-positive. Overall, 21 patients (11.7% of the total cohort and 45.6% of amyloid-positive individuals) fulfilled all AUR criteria for donanemab. Requiring concomitant CSF p-tau positivity further reduced eligibility to 13 patients, accounting for 7.3% of the total cohort.ConclusionsAlthough ATTs represent a novel therapeutic option that targets the underlying AD pathology, their real-world applicability remains limited to a small patient fraction, narrowing further under strict biological stratification. Concerns regarding cost-effectiveness and practical implementation persist. Early-stage AD diagnosis and precise stratification are paramount to ensure that the promise of disease-modifying therapies can be translated into tangible clinical impact.