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

Authors

Francesco Motolese, Francesca Ursini, Davide Norata, Fioravante Capone, Elisabetta Sapio, Maria Luisa Di Giesi, Silvia Antonella Selvaggi, Gabriele Annesi, Mariagrazia Rossi, Rosalinda Calandrelli, Carlo Augusto Mallio, Caterina Bernetti, Michele Tondo, Bruno Beomonte Zobel, Eliodoro Faiella, Fabio Pilato, Vincenzo Di Lazzaro

Published in

Journal of Alzheimer's disease : JAD. Pages 13872877261488813. Sep 28, 2026. Epub Sep 28, 2026.

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.

PMID:
42803707
Bibliographic data and abstract were imported from PubMed on 28 Sep 2026.

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