Updated Italian intersocietal recommendations for the appropriate use of anti-amyloid monoclonal antibodies in Alzheimer's disease - 10/10/26
, Federica Agosta 3, 4, 5, Luisa Agnello 6, 7, Alba Rosa Alfano 8, Mattia Altini 9, 10, Antonio Antico 11, Stefania Basilico 12, 13, 14, Giuseppe Bellelli 15, 16, Laura Bonanni 17, Gabriella Bottini 12, 13, 14, Marco Bozzali 18, 19, Ovidio Brignoli 20, Giuseppe Bruno 21, Annachiara Cagnin 22, 23, Sonia Francesca Calloni 24, Stefano F. Cappa 25, 26, Filippo Caraci 27, 28, Diego Cecchin 23, 29, Marcello Ciaccio 6, 7, Sirio Cocozza 30, Mirco Cosottini 31, 32, Diego De Leo 33, 34, 35, Andrea Falini 5, 24, Lorenzo Gaetani 36, Nicoletta Gandolfo 37, Fabio Gotta 38, 39, Raffaele Lodi 40, 41, Giancarlo Logroscino 42, 43, Elena Marcello 44, Camillo Marra 45, 46, Walter Marrocco 47, Silvia Morbelli 48, 49, Patrizia Mecocci 50, 51, Enrico Mossello 52, Lorenzo Palleschi 8, Pasquale Palumbo 53, Leonardo Pantoni 54, 55, 56, Lucilla Parnetti 36, Luca Roccatagliata 57, 58, Sandro Sorbi 59, 60, 61, Patrizia Spadin 62, Alessandra Splendiani 63, 64, Alessandro Tessitore 65, Andrea Ungar 52, Giuseppe Zappalà 66, Alessandro Padovani 67, 68, 69, 70Abstract |
With the European authorisation of lecanemab and donanemab, Italy is entering the era of disease-modifying therapy for early symptomatic Alzheimer's disease. The Italian Expert Panel on Alzheimer (EPA), which convened 21 scientific societies and patient associations and published a first set of intersocietal recommendations in 2025, was reconvened in Rome on 24 January 2026 (EPA2) to address the operational gaps that had emerged during the implementation of that document. A modified Delphi process was adopted to formalise consensus on the most controversial points raised during the meeting. Thirty-six declarative statements covering five domains, namely the tiered organisation of the Centres for Cognitive Disorders and Dementia (CDCD), clinical staging and treatment monitoring, eligibility considerations in mild cognitive impairment and atypical phenotypes, composition of the multidisciplinary team, and magnetic resonance imaging thresholds, ARIA monitoring and biomarker pathway, were submitted to a multidisciplinary panel of experts. Strong agreement was reached on the large majority of statements, providing quantitative endorsement for a competence-based reorganisation of the CDCD network, the harmonised use of the Clinical Dementia Rating, an explicit composition of the multidisciplinary team, trial-aligned magnetic resonance imaging eligibility criteria with a move towards risk-adapted ARIA monitoring, and a stepwise biomarker pathway integrating plasma assays, cerebrospinal fluid analysis on automated platforms and amyloid positron emission tomography. The document provides Italian regional and national health systems, prescribing centres and reimbursing authorities with a quantitative blueprint for the appropriate, equitable and sustainable use of anti-amyloid monoclonal antibodies in clinical practice.
Le texte complet de cet article est disponible en PDF.Keywords : Alzheimer’s disease, disease-modifying therapies, anti-amyloid monoclonal antibodies, biomarkers, clinical implementation
Abbreviations : AD, APOE, ARIA, ARIA-E, ARIA-H, CDCD, CDR, CDR-SB, CE-IVDR, CSF, DMT, EMA, EPA, EPA2, GRE, MCI, MMSE, MoCA, MRI, PDTA, PET, p-tau217, SWI
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