Italian intersocietal recommendations for restructuring the diagnostic-therapeutic pathway for the implementation and appropriate use of anti-amyloid monoclonal antibodies in Alzheimer's disease

Alberto Benussi^{1

2}, Federica Agosta^{3

4

5}, Alba Rosa Alfano⁶, Antonio Antico⁷, Giuseppe Bellelli^{8

9}, Laura Bonanni¹⁰, Gabriella Bottini^{11

12

13}, Marco Bozzali^{14

15}, Ovidio Brignoli¹⁶, Giuseppe Bruno¹⁷, Annachiara Cagnin^{18

19}, Sonia Francesca Calloni²⁰, Diego Cecchin^{19

21}, Marcello Ciaccio^{22

23}, Sirio Cocozza²⁴, Mirco Cosottini^{25

26}, Diego De Leo^{27

28

29}, Andrea Falini^{5

20}, Lorenzo Gaetani³⁰, Fabio Gotta^{31

32}, Maria Infantino³³, Raffaele Lodi^{34

35}, Giancarlo Logroscino^{36

37}, Elena Marcello³⁸, Camillo Marra^{39

40}, Walter Marrocco⁴¹, Patrizia Mecocci^{42

43}, Enrico Mossello⁴⁴, Alessandro Padovani^{45

46

47

48}, Lorenzo Palleschi⁴⁹, Leonardo Pantoni^{50

51

52}, Lucilla Parnetti³⁰, Sandro Sorbi^{53

54

55}, Alessandro Tessitore⁵⁶, Andrea Ungar⁴⁴

Affiliations

¹ Neurology Unit, Department of Medical, Surgical and Health Sciences, University of Trieste, Strada di Fiume, 447, 34149, Trieste, Italy. benussialberto@gmail.com.
² Neurology Clinic, Department of Medicine, Surgery and Health Sciences, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy. benussialberto@gmail.com.
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 Internal Medicine and Medical Specialties, UOC Geriatrics, Sapienza University of Rome, Rome, Italy.
⁷ Department of Laboratory Medicine, Hospital "Ca' Foncello", Treviso, Italy.
⁸ School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
⁹ Acute Geriatric Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
¹⁰ Department of Medicine and Aging Sciences, "G. d'Annunzio" University of Chieti-Pescara, Chieti, Italy.
¹¹ Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
¹² Cognitive Neuropsychology Centre, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
¹³ NeuroMi - Milan Center for Neuroscience, Milan, Italy.
¹⁴ "Rita Levi-Montalcini" Department of Neuroscience, University of Torino, Turin, Italy.
¹⁵ Neurology Unit 2U, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
¹⁶ Italian College of General Practitioners and Primary Care Professionals (SIMG), Florence, Italy.
¹⁷ Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.
¹⁸ Department of Neuroscience, University of Padova, Padova, Italy.
¹⁹ Padua Neuroscience Center, University of Padova, Padova, Italy.
²⁰ Neuroradiology Unit & CERMAC, IRCCS Ospedale San Raffaele, Milan, Italy.
²¹ Nuclear Medicine Unit, Department of Medicine (DIMED), University of Padova, Padova, Italy.
²² Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Palermo, Italy.
²³ Department of Laboratory Medicine, University Hospital "Paolo Giaccone", Palermo, Italy.
²⁴ Department of Advanced Biomedical Sciences, University "Federico II", Naples, Italy.
²⁵ Neuroradiology Unit, Department of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
²⁶ Neuroradiology Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
²⁷ Australian Institute for Suicide Research and Prevention, Griffith University, Nathan, QLD, Australia.
²⁸ Slovene Centre for Suicide Research, University of Primorska, Koper, Slovenia.
²⁹ De Leo Fund, Padova, Italy.
³⁰ Section of Neurology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
³¹ Unit of Medical Genetics, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
³² Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Health (DINOGMI), University of Genova, Genoa, Italy.
³³ Immunology and Allergology Laboratory Unit, Ospedale San Giovanni di Dio, Azienda USL Toscana Centro, Florence, Italy.
³⁴ Functional and Molecular Neuroimaging Unit, IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
³⁵ Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, Italy.
³⁶ Center for Neurodegenerative Diseases and the Aging Brain, University of Bari "Aldo Moro", Tricase, Lecce, Italy.
³⁷ Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari "Aldo Moro", Bari, Italy.
³⁸ Department of Pharmacological and Biomolecular Sciences "Rodolfo Paoletti", University of Milan, Milan, Italy.
³⁹ Memory Clinic, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
⁴⁰ Department of Neuroscience, Catholic University of the Sacred Heart, Rome, Italy.
⁴¹ Federazione Italiana Medici di Medicina Generale (FIMMG), Rome, Italy.
⁴² Division of Gerontology and Geriatrics, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
⁴³ Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
⁴⁴ Division of Geriatric and Intensive Care Medicine, University of Florence & Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
⁴⁵ Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
⁴⁶ Neurology Unit, Department of Continuity of Care and Frailty, ASST Spedali Civili di Brescia, Brescia, Italy.
⁴⁷ Neurobiorepository and Advanced Biomarkers Laboratory, University of Brescia & ASST Spedali Civili di Brescia, Brescia, Italy.
⁴⁸ Brain Health Center, University of Brescia, Brescia, Italy.
⁴⁹ Unit of Geriatrics, Medical Department, San Giovanni-Addolorata Hospital, Rome, Italy.
⁵⁰ Neurology and Stroke Unit, Luigi Sacco University Hospital, Milan, Italy.
⁵¹ Department of Biomedical and Clinical Sciences, Neuroscience Research Center, University of Milan, Milan, Italy.
⁵² Department of Neurorehabilitation Sciences, Casa di Cura Igea, Milan, Italy.
⁵³ Department of Neuroscience, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.
⁵⁴ IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
⁵⁵ Fondazione Villa Serena per la Ricerca, Città Sant'Angelo, Pescara, Italy.
⁵⁶ Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.

PMID: 41102550
DOI: 10.1007/s10072-025-08576-y

Italian intersocietal recommendations for restructuring the diagnostic-therapeutic pathway for the implementation and appropriate use of anti-amyloid monoclonal antibodies in Alzheimer's disease

Alberto Benussi et al. Neurol Sci. 2025.

. 2025 Oct 17.

doi: 10.1007/s10072-025-08576-y. Online ahead of print.

Authors

Affiliations

¹ Neurology Unit, Department of Medical, Surgical and Health Sciences, University of Trieste, Strada di Fiume, 447, 34149, Trieste, Italy. benussialberto@gmail.com.
² Neurology Clinic, Department of Medicine, Surgery and Health Sciences, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy. benussialberto@gmail.com.
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 Internal Medicine and Medical Specialties, UOC Geriatrics, Sapienza University of Rome, Rome, Italy.
⁷ Department of Laboratory Medicine, Hospital "Ca' Foncello", Treviso, Italy.
⁸ School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
⁹ Acute Geriatric Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
¹⁰ Department of Medicine and Aging Sciences, "G. d'Annunzio" University of Chieti-Pescara, Chieti, Italy.
¹¹ Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy.
¹² Cognitive Neuropsychology Centre, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy.
¹³ NeuroMi - Milan Center for Neuroscience, Milan, Italy.
¹⁴ "Rita Levi-Montalcini" Department of Neuroscience, University of Torino, Turin, Italy.
¹⁵ Neurology Unit 2U, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy.
¹⁶ Italian College of General Practitioners and Primary Care Professionals (SIMG), Florence, Italy.
¹⁷ Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy.
¹⁸ Department of Neuroscience, University of Padova, Padova, Italy.
¹⁹ Padua Neuroscience Center, University of Padova, Padova, Italy.
²⁰ Neuroradiology Unit & CERMAC, IRCCS Ospedale San Raffaele, Milan, Italy.
²¹ Nuclear Medicine Unit, Department of Medicine (DIMED), University of Padova, Padova, Italy.
²² Department of Biomedicine, Neurosciences and Advanced Diagnostics, University of Palermo, Palermo, Italy.
²³ Department of Laboratory Medicine, University Hospital "Paolo Giaccone", Palermo, Italy.
²⁴ Department of Advanced Biomedical Sciences, University "Federico II", Naples, Italy.
²⁵ Neuroradiology Unit, Department of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy.
²⁶ Neuroradiology Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy.
²⁷ Australian Institute for Suicide Research and Prevention, Griffith University, Nathan, QLD, Australia.
²⁸ Slovene Centre for Suicide Research, University of Primorska, Koper, Slovenia.
²⁹ De Leo Fund, Padova, Italy.
³⁰ Section of Neurology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
³¹ Unit of Medical Genetics, IRCCS Ospedale Policlinico San Martino, Genoa, Italy.
³² Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Health (DINOGMI), University of Genova, Genoa, Italy.
³³ Immunology and Allergology Laboratory Unit, Ospedale San Giovanni di Dio, Azienda USL Toscana Centro, Florence, Italy.
³⁴ Functional and Molecular Neuroimaging Unit, IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy.
³⁵ Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, Italy.
³⁶ Center for Neurodegenerative Diseases and the Aging Brain, University of Bari "Aldo Moro", Tricase, Lecce, Italy.
³⁷ Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari "Aldo Moro", Bari, Italy.
³⁸ Department of Pharmacological and Biomolecular Sciences "Rodolfo Paoletti", University of Milan, Milan, Italy.
³⁹ Memory Clinic, Fondazione Policlinico Universitario "A. Gemelli" IRCCS, Rome, Italy.
⁴⁰ Department of Neuroscience, Catholic University of the Sacred Heart, Rome, Italy.
⁴¹ Federazione Italiana Medici di Medicina Generale (FIMMG), Rome, Italy.
⁴² Division of Gerontology and Geriatrics, Department of Medicine and Surgery, University of Perugia, Perugia, Italy.
⁴³ Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden.
⁴⁴ Division of Geriatric and Intensive Care Medicine, University of Florence & Azienda Ospedaliero-Universitaria Careggi, Florence, Italy.
⁴⁵ Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy.
⁴⁶ Neurology Unit, Department of Continuity of Care and Frailty, ASST Spedali Civili di Brescia, Brescia, Italy.
⁴⁷ Neurobiorepository and Advanced Biomarkers Laboratory, University of Brescia & ASST Spedali Civili di Brescia, Brescia, Italy.
⁴⁸ Brain Health Center, University of Brescia, Brescia, Italy.
⁴⁹ Unit of Geriatrics, Medical Department, San Giovanni-Addolorata Hospital, Rome, Italy.
⁵⁰ Neurology and Stroke Unit, Luigi Sacco University Hospital, Milan, Italy.
⁵¹ Department of Biomedical and Clinical Sciences, Neuroscience Research Center, University of Milan, Milan, Italy.
⁵² Department of Neurorehabilitation Sciences, Casa di Cura Igea, Milan, Italy.
⁵³ Department of Neuroscience, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy.
⁵⁴ IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy.
⁵⁵ Fondazione Villa Serena per la Ricerca, Città Sant'Angelo, Pescara, Italy.
⁵⁶ Department of Advanced Medical and Surgical Sciences, University of Campania "Luigi Vanvitelli", Naples, Italy.

PMID: 41102550
DOI: 10.1007/s10072-025-08576-y

Abstract

This joint Position Paper, developed by the Italian Expert Panel on Alzheimer convened by the Italian Society of Neurology with participation from multiple scientific societies, outlines strategic guidelines for reorganizing the patient journey in the era of anti-amyloid monoclonal antibodies for Alzheimer's disease. Emphasizing a multidisciplinary and integrated approach, the document recommends a patient journey that begins with early identification of cognitive impairment by General Practitioners, continues with specialized assessments at Memory and Dementia Centres, and leads, in carefully selected cases, to initiation of anti-amyloid monoclonal antibody therapy. It advocates the rational use of diagnostic tools, including plasma and cerebrospinal fluid biomarkers, advanced neuroimaging (MRI and PET), and genetic profiling (ApoE genotyping), not only to identify eligible patients but also to stratify those requiring alternative care strategies. The paper further defines minimum requirements for the accreditation of prescribing and infusion centres, highlighting the clinical competencies, structural resources, and inter-professional communication protocols necessary to ensure safety and appropriateness. Recognizing both the therapeutic potential and the organizational challenges associated with anti-amyloid monoclonal antibodies, the document aims to guide healthcare policymakers, institutions, and practitioners toward a coordinated reorganization of the diagnostic-therapeutic pathway, ensuring the safe and effective use of these treatments and ultimately improving outcomes and quality of care for individuals with Alzheimer's disease.

Keywords: Alzheimer’s disease; Anti-amyloid monoclonal antibodies; Biomarkers; Clinical implementation; Disease-modifying therapies.

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Conflict of interest statement

Declarations. Ethical approval and Informed consent: This position paper does not require formal Health Ethical Approval as it does not report data collected on patients or humans. Conflict of Interest: This position paper did not receive any dedicated grant from public agencies, commercial enterprises, or not-for-profit organisations. The meeting of the expert panel on Alzheimer (EPA) held in Florence on 24 January 2025 was organised and fully financed with internal funds of the Italian Society of Neurology (SIN) together with the collaborating scientific societies listed in the manuscript. No industry sponsorship was involved in the planning, drafting, or decision to submit the present work. Alba Rosa Alfano reports no relevant conflicts of interest. Federica Agosta is Associate Editor of NeuroImage: Clinical and has received speaker honoraria from Biogen Idec, Eli Lilly, Roche, Zambon, and Italfarmaco, and editing fees from Elsevier; she received research support from the Italian Ministry of Health, the Italian Ministry of University & Research, AriSLA, the European Research Council, and the Foundation for Alzheimer’s Research. Antonio Antico reports no conflicts of interest. Alberto Benussi has received speaker honoraria from Eli Lilly and Angelini Pharma; he received research grants from Airalzh, Fondazione Cariplo, the Fondation pour la Recherche sur Alzheimer, and the Italian Ministry of University & Research; he is listed as an inventor on issued patents on the use of non-invasive brain stimulation for the differential diagnosis of dementia and to increase cognitive functions in patients with neurodegenerative disorders. Giuseppe Bellelli has received research funding from the Italian Ministry of Health and University, and has received speaker honoraria from Eli Lilly, PIAM, GSK, Italfarmaco, Nestlé and Damor. Gabriella Bottini reports no conflicts of interest. Marco Bozzali reports no conflicts of interest. Ovidio Brignoli reports no conflicts of interest. Giuseppe Bruno reports no conflicts of interest; he received financial compensation from Eli Lilly for participation on the GERAS advisory board. Annachiara Cagnin has received consulting fees and/or speaker honoraria from Eli Lilly, Biogen, Eisai, Roche, PIAM, Novonordisk and Lundbeck, and research support from the Italian Ministry of Health and Regione Veneto. Sonia Francesca Calloni reports no conflicts of interest. Diego Cecchin reports no conflicts of interest. Marcello Ciaccio reports no conflicts of interest. Sirio Cocozza has served on an Amicus Therapeutics advisory board, has received speaker fees from Sanofi and Amicus Therapeutics, and research funding from the Fondazione Italiana Sclerosi Multipla. Mirco Cosottini has received a speaker honorarium from GE Healthcare, Ely Lilli, Roche. Diego De Leo has received consulting fees and/or speaker honoraria from Lundbeck, Neopharmed, and PIAM. Andrea Falini reports no conflicts of interest. Lorenzo Gaetani has received honoraria, travel grants, or advisory board fees from Almirall, Biogen, Euroimmun, Merck, Mylan, Novartis, Roche, Sanofi, Siemens Healthineers, Teva, Fujirebio, and Eli Lilly. Fabio Gotta reports no conflicts of interest. Maria Infantino reports no conflicts of interest. Raffaele Lodi reports no conflicts of interest. Giancarlo Logroscino has served as investigator for clinical trials sponsored by Biogen Pharmaceuticals, Axovant, Alector, Denali, Roche, Eisai, Genentech, Amylyx, PIAM Farmaceutici SpA; he has served as a consultant and has given Lectures for EISAI, Roche, Lilly, Piam Farmaceutici Spa, Biogen. Elena Marcello has received speaker honoraria from Eli Lilly and GE Healthcare, advisory board fees from Roche, teaching fees from Eisai; she has received research grants from the Italian Ministry of Research and University, Giovanni Armenise Harvard Foundation, AIRALZH ONLUS, the Italian Ministry of Enterprises and Made in Italy, Alzheimer Association, Bright Focus Foundation. Camillo Marra has received research support from Novo Nordisk and speaker honoraria from Biogen, Roche, Novo Nordisk, PIAM, and Angelini.Walter Marrocco reports no conflicts of interest. Patrizia Mecocci has received grants/contracts from HORIZON-JU-RIA Program AD-Riddle and Horizon 2020 Lethe, honoraria from PIAM, Angelini, and Epitech, and served on the advisory board of Primus. Enrico Mossello has been principal investigator in Novo Nordisk, Avanir and Eli Lilly trials and has received speaker honoraria from Eli Lilly, Johnson and Johnson, and Neuraxpharm. Alessandro Padovani is a consultant and scientific advisory board member for GE Healthcare, Eli Lilly, and Actelion; he has received speaker honoraria from Nutricia, PIAM, Langstone Technology, GE Healthcare, Lilly, UCB Pharma, and Chiesi, and research funding from Nutricia, Roche, GE Healthcare, Eli Lilly, Biogen, Pfizer, Lundbeck, the Italian Ministry of Health, and IMI H2020 initiatives. Lorenzo Palleschi reports no conflicts of interest. Leonardo Pantoni is member of the editorial board of Neurology, Cerebrovascular Diseases, European Stroke Journal, Cerebral Circulation Cognition and Behavior, and associate editor of Neurological Sciences; he has received consultancy fees from Medtronic, PIAM and Amicus. Lucilla Parnetti serves on advisory boards for Fujirebio, IBL, Roche, and Merck and holds collaboration contracts with ADx Neurosciences, Amprion Inc., and Fujirebio. Sandro Sorbi reports no conflicts of interest. Alessandro Tessitore has served as associate editor for European Journal of Neurology, serves on advisory boards for Zambon, Eli Lilly and received speaker honoraria from Lundbeck, AbbVie, Bial, Eli Lilly, TEVA, Zambon, UCB Pharma, and Chiesi, and research funding from the Italian Ministry of Health, and Italian Ministry of University & Research. Andrea Ungar reports no conflicts of interest.

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Italian intersocietal recommendations for restructuring the diagnostic-therapeutic pathway for the implementation and appropriate use of anti-amyloid monoclonal antibodies in Alzheimer's disease

Affiliations

Italian intersocietal recommendations for restructuring the diagnostic-therapeutic pathway for the implementation and appropriate use of anti-amyloid monoclonal antibodies in Alzheimer's disease

Authors

Affiliations

Abstract

Conflict of interest statement

References

LinkOut - more resources

Full Text Sources

Miscellaneous