Updated Italian intersocietal recommendations for the appropriate use of anti-amyloid monoclonal antibodies in Alzheimer's disease - 10/10/26

Doi : 10.1016/j.tjpad.2026.100685 
Alberto Benussi 1, 2, ⁎ , 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, 70
1 Neurology Unit, Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy 
2 Neurology Clinic, Department of Medicine, Surgery and Health Sciences, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy 
3 Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy 
4 Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy 
5 Vita-Salute San Raffaele University, Milan, Italy 
6 Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine, and Clinical Laboratory Medicine, University of Palermo, Palermo, Italy 
7 Department of Laboratory Medicine, University Hospital “Paolo Giaccone”, Palermo, Italy 
8 Unit of Geriatrics, Medical Department, San Giovanni-Addolorata Hospital, Rome, Italy 
9 Modena Local Health Authority (Azienda USL Modena), Modena, Italy 
10 Italian Society of Leadership and Management in Medicine (SIMM), Rome, Italy 
11 Department of Laboratory Medicine, Hospital “Ca’ Foncello”, Treviso, Italy 
12 Cognitive Neuropsychology Centre, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy 
13 Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy 
14 NeuroMi - Milan Center for Neuroscience, Milan, Italy 
15 School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy 
16 Acute Geriatric Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy 
17 Department of Medicine and Aging Sciences, “G. d’Annunzio” University of Chieti-Pescara, Chieti, Italy 
18 “Rita Levi-Montalcini” Department of Neuroscience, University of Torino, Turin, Italy 
19 Neurology Unit 2U, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy 
20 Italian College of General Practitioners and Primary Care Professionals (SIMG), Florence, Italy 
21 Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy 
22 Department of Neuroscience, University of Padova, Padova, Italy 
23 Padova Neuroscience Center, University of Padova, Padova, Italy 
24 Neuroradiology Unit & CERMAC, IRCCS Ospedale San Raffaele, Milan, Italy 
25 IUSS Cognitive Neuroscience (ICoN) Center, University Institute of Advanced Studies IUSS, Pavia, Italy 
26 IRCCS Istituto Auxologico Italiano, Milan, Italy 
27 Department of Drug and Health Sciences, University of Catania, Catania, Italy 
28 Oasi Research Institute-IRCCS, Troina, Italy 
29 Nuclear Medicine Unit, Department of Medicine (DIMED), University Hospital of Padova, Padova, Italy 
30 Neuroradiology Unit, University Hospital “Federico II”, Naples, Italy 
31 Neuroradiology Unit, Department of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy 
32 Neuroradiology Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy 
33 Australian Institute for Suicide Research and Prevention, Griffith University, Nathan, QLD, Australia 
34 Slovene Centre for Suicide Research, University of Primorska, Koper, Slovenia 
35 De Leo Fund, Padova, Italy 
36 Section of Neurology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy 
37 Dipartimento Immagini, SC Radiologia, Ospedale Villa Scassi - IRCCS AOM, Genova 
38 Unit of Medical Genetics, IRCCS Ospedale Policlinico San Martino, Genoa, Italy 
39 Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Health (DINOGMI), University of Genova, Genoa, Italy 
40 Functional and Molecular Neuroimaging Unit, IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy 
41 Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, Italy 
42 Center for Neurodegenerative Diseases and the Aging Brain, University of Bari “Aldo Moro”, Tricase-Lecce, Italy 
43 Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari “Aldo Moro”, Bari, Italy 
44 Department of Pharmacological and Biomolecular Sciences “Rodolfo Paoletti”, University of Milan, Milan, Italy 
45 Memory Clinic, Fondazione Policlinico Universitario “A. Gemelli” IRCCS, Rome, Italy 
46 Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy 
47 Federazione Italiana Medici di Medicina Generale (FIMMG), Rome, Italy 
48 Nuclear Medicine Unit, AOU Città della Salute e della Scienza di Torino, Turin, Italy 
49 Department of Medical Sciences, University of Turin, Turin, Italy 
50 Division of Gerontology and Geriatrics, Department of Medicine and Surgery, University of Perugia, Perugia, Italy 
51 Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden 
52 Division of Geriatric and Intensive Care Medicine, University of Florence & Azienda Ospedaliero-Universitaria Careggi, Florence, Italy 
53 Neurology, Neurophysiopathology, and Stroke Unit, Santo Stefano Hospital, Prato, Italy 
54 Neurology and Stroke Unit, Luigi Sacco University Hospital, Milan, Italy 
55 Department of Biomedical and Clinical Sciences, Neuroscience Research Center, University of Milan, Milan, Italy 
56 Department of Neurorehabilitation Sciences, Casa di Cura Igea, Milan, Italy 
57 Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy 
58 Neuroradiology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy 
59 Department of Neuroscience, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy 
60 IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy 
61 Fondazione Villa Serena per la Ricerca, Città Sant’Angelo, Pescara, Italy 
62 Associazione Italiana Malattia Alzheimer-AIMA, Milan, Italy 
63 Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy 
64 Neuroradiology Unit, San Salvatore Hospital, L'Aquila, Italy 
65 Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy 
66 Neurology Unit and Centre for Cognitive Disorders and Dementia, ARNAS Garibaldi, Catania, Italy 
67 Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy 
68 Neurology Unit, Department of Continuity of Care and Frailty, ASST Spedali Civili di Brescia, Brescia, Italy 
69 Neurobiorepository and Advanced Biomarkers Laboratory, University of Brescia & ASST Spedali Civili di Brescia, Brescia, Italy 
70 Brain Health Center, University of Brescia, Brescia, Italy 

⁎ Corresponding Author: Alberto Benussi, MD, Department of Medical, Surgical and Health Sciences, University of Trieste, Strada di Fiume, 447 34149 Trieste, Italy Department of Medical, Surgical and Health Sciences, University of Trieste Strada di Fiume Trieste 447 34149 Italy

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Abstract

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.

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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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