Updated Italian intersocietal recommendations for the appropriate use of anti-amyloid monoclonal antibodies in Alzheimer's disease - 15/10/26

Doi : 10.1016/j.tjpad.2026.100685 
Alberto Benussi a, b, ⁎ , Federica Agosta c, d, e, Luisa Agnello f, g, Alba Rosa Alfano h, Mattia Altini i, j, Antonio Antico k, Stefania Basilico l, m, n, Giuseppe Bellelli o, p, Laura Bonanni q, Gabriella Bottini l, m, n, Marco Bozzali r, s, Ovidio Brignoli t, Giuseppe Bruno u, Annachiara Cagnin v, w, Sonia Francesca Calloni x, Stefano F. Cappa y, z, Filippo Caraci aa, bb, Diego Cecchin w, cc, Marcello Ciaccio f, g, Sirio Cocozza dd, Mirco Cosottini ee, ff, Diego De Leo gg, hh, ii, Andrea Falini e, x, Lorenzo Gaetani jj, Nicoletta Gandolfo kk, Fabio Gotta ll, mm, Raffaele Lodi nn, oo, Giancarlo Logroscino pp, qq, Elena Marcello rr, Camillo Marra ss, tt, Walter Marrocco uu, Silvia Morbelli vv, ww, Patrizia Mecocci xx, yy, Enrico Mossello zz, Lorenzo Palleschi h, Pasquale Palumbo aaa, Leonardo Pantoni bbb, ccc, ddd, Lucilla Parnetti jj, Luca Roccatagliata eee, fff, Sandro Sorbi ggg, hhh, iii, Patrizia Spadin jjj, Alessandra Splendiani kkk, lll, Alessandro Tessitore mmm, Andrea Ungar zz, Giuseppe Zappalà nnn, Alessandro Padovani ooo, ppp, qqq, rrr
a Neurology Unit, Department of Medical, Surgical and Health Sciences, University of Trieste, Trieste, Italy 
b Neurology Clinic, Department of Medicine, Surgery and Health Sciences, Azienda Sanitaria Universitaria Giuliano Isontina, Trieste, Italy 
c Neuroimaging Research Unit, Division of Neuroscience, IRCCS San Raffaele Scientific Institute, Milan, Italy 
d Neurology Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy 
e Vita-Salute San Raffaele University, Milan, Italy 
f Department of Biomedicine, Neurosciences and Advanced Diagnostics, Institute of Clinical Biochemistry, Clinical Molecular Medicine, and Clinical Laboratory Medicine, University of Palermo, Palermo, Italy 
g Department of Laboratory Medicine, University Hospital “Paolo Giaccone”, Palermo, Italy 
h Unit of Geriatrics, Medical Department, San Giovanni-Addolorata Hospital, Rome, Italy 
i Modena Local Health Authority (Azienda USL Modena), Modena, Italy 
j Italian Society of Leadership and Management in Medicine (SIMM), Rome, Italy 
k Department of Laboratory Medicine, Hospital “Ca’ Foncello”, Treviso, Italy 
l Cognitive Neuropsychology Centre, ASST Grande Ospedale Metropolitano Niguarda, Milan, Italy 
m Department of Brain and Behavioral Sciences, University of Pavia, Pavia, Italy 
n NeuroMi - Milan Center for Neuroscience, Milan, Italy 
o School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy 
p Acute Geriatric Unit, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy 
q Department of Medicine and Aging Sciences, “G. d’Annunzio” University of Chieti-Pescara, Chieti, Italy 
r “Rita Levi-Montalcini” Department of Neuroscience, University of Torino, Turin, Italy 
s Neurology Unit 2U, Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino, Turin, Italy 
t Italian College of General Practitioners and Primary Care Professionals (SIMG), Florence, Italy 
u Department of Human Neuroscience, Sapienza University of Rome, Rome, Italy 
v Department of Neuroscience, University of Padova, Padova, Italy 
w Padova Neuroscience Center, University of Padova, Padova, Italy 
x Neuroradiology Unit & CERMAC, IRCCS Ospedale San Raffaele, Milan, Italy 
y IUSS Cognitive Neuroscience (ICoN) Center, University Institute of Advanced Studies IUSS, Pavia, Italy 
z IRCCS Istituto Auxologico Italiano, Milan, Italy 
aa Department of Drug and Health Sciences, University of Catania, Catania, Italy 
bb Oasi Research Institute-IRCCS, Troina, Italy 
cc Nuclear Medicine Unit, Department of Medicine (DIMED), University Hospital of Padova, Padova, Italy 
dd Neuroradiology Unit, University Hospital “Federico II”, Naples, Italy 
ee Neuroradiology Unit, Department of Translational Research on New Technologies in Medicine and Surgery, University of Pisa, Pisa, Italy 
ff Neuroradiology Unit, Azienda Ospedaliero-Universitaria Pisana, Pisa, Italy 
gg Australian Institute for Suicide Research and Prevention, Griffith University, Nathan, QLD, Australia 
hh Slovene Centre for Suicide Research, University of Primorska, Koper, Slovenia 
ii De Leo Fund, Padova, Italy 
jj Section of Neurology, Department of Medicine and Surgery, University of Perugia, Perugia, Italy 
kk Dipartimento Immagini, SC Radiologia, Ospedale Villa Scassi - IRCCS AOM, Genova, Italy 
ll Unit of Medical Genetics, IRCCS Ospedale Policlinico San Martino, Genoa, Italy 
mm Department of Neuroscience, Rehabilitation, Ophthalmology, Genetics and Maternal and Child Health (DINOGMI), University of Genova, Genoa, Italy 
nn Functional and Molecular Neuroimaging Unit, IRCCS Istituto delle Scienze Neurologiche di Bologna, Bologna, Italy 
oo Department of Biomedical and Neuromotor Sciences (DIBINEM), University of Bologna, Bologna, Italy 
pp Center for Neurodegenerative Diseases and the Aging Brain, University of Bari “Aldo Moro”, Tricase-Lecce, Italy 
qq Department of Translational Biomedicine and Neuroscience (DiBraiN), University of Bari “Aldo Moro”, Bari, Italy 
rr Department of Pharmacological and Biomolecular Sciences “Rodolfo Paoletti”, University of Milan, Milan, Italy 
ss Memory Clinic, Fondazione Policlinico Universitario “A. Gemelli” IRCCS, Rome, Italy 
tt Department of Psychology, Catholic University of the Sacred Heart, Milan, Italy 
uu Federazione Italiana Medici di Medicina Generale (FIMMG), Rome, Italy 
vv Nuclear Medicine Unit, AOU Città della Salute e della Scienza di Torino, Turin, Italy 
ww Department of Medical Sciences, University of Turin, Turin, Italy 
xx Division of Gerontology and Geriatrics, Department of Medicine and Surgery, University of Perugia, Perugia, Italy 
yy Division of Clinical Geriatrics, Department of Neurobiology, Care Sciences and Society, Karolinska Institutet, Stockholm, Sweden 
zz Division of Geriatric and Intensive Care Medicine, University of Florence & Azienda Ospedaliero-Universitaria Careggi, Florence, Italy 
aaa Neurology, Neurophysiopathology, and Stroke Unit, Santo Stefano Hospital, Prato, Italy 
bbb Neurology and Stroke Unit, Luigi Sacco University Hospital, Milan, Italy 
ccc Department of Biomedical and Clinical Sciences, Neuroscience Research Center, University of Milan, Milan, Italy 
ddd Department of Neurorehabilitation Sciences, Casa di Cura Igea, Milan, Italy 
eee Department of Health Sciences (DISSAL), University of Genoa, Genoa, Italy 
fff Neuroradiology Unit, IRCCS Ospedale Policlinico San Martino, Genoa, Italy 
ggg Department of Neuroscience, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Florence, Italy 
hhh IRCCS Fondazione Don Carlo Gnocchi, Florence, Italy 
iii Fondazione Villa Serena per la Ricerca, Città Sant’Angelo, Pescara, Italy 
jjj Associazione Italiana Malattia Alzheimer-AIMA, Milan, Italy 
kkk Department of Biotechnological and Applied Clinical Sciences, University of L'Aquila, L'Aquila, Italy 
lll Neuroradiology Unit, San Salvatore Hospital, L'Aquila, Italy 
mmm Department of Advanced Medical and Surgical Sciences, University of Campania “Luigi Vanvitelli”, Naples, Italy 
nnn Neurology Unit and Centre for Cognitive Disorders and Dementia, ARNAS Garibaldi, Catania, Italy 
ooo Neurology Unit, Department of Clinical and Experimental Sciences, University of Brescia, Brescia, Italy 
ppp Neurology Unit, Department of Continuity of Care and Frailty, ASST Spedali Civili di Brescia, Brescia, Italy 
qqq Neurobiorepository and Advanced Biomarkers Laboratory, University of Brescia & ASST Spedali Civili di Brescia, Brescia, Italy 
rrr Brain Health Center, University of Brescia, Brescia, Italy 

⁎ Corresponding author at: 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


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Vol 13 - N° 10

Article 100685- décembre 2026 Retour au numéro
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