Cited by 14Alzheimer's disease research and treatmentsDementia and Cognitive Impairment ResearchCholinesterase and Neurodegenerative Diseases

Anti-amyloid therapies and the transformation of Alzheimer's care pathways: early lessons from the frontline

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Filippi, Massimo, Cecchetti, Giordano, Spinelli, Edoardo G., Ghirelli, Alma, Rugarli, Giulia, Pisano, Stefano, Canu, Elisa, Agosta, Federica·2026·The Lancet Regional Health - Europe

Abstract

The introduction of anti-amyloid monoclonal antibodies marks a major shift in Alzheimer's disease (AD) care, moving treatment toward biological modification and reshaping diagnostic and organizational models. At the Center for Alzheimer's and Related Diseases (CARD), IRCCS San Raffaele Hospital (Milan, Italy), among the first European tertiary centers to initiate both lecanemab and donanemab, we developed a structured fast-track pathway to support timely and safe access to therapy. Our early real-world experience highlights three critical domains. First, patient selection requires integration of cognitive, functional, and biological data, moving beyond rigid global score thresholds. Second, safety monitoring must balance ARIA risk with real-world feasibility through risk-adapted MRI surveillance. Third, effective implementation depends on transparent communication and continuous shared decision-making, particularly when benefit is uncertain or safety events occur. These elements underscore that the impact of disease-modifying therapies will depend not only on pharmacology, but on coordinated care models supported by real-world registries.

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  • In line with previous proposals of a stepwise approach, such a model may balance analytical performance with clinical safety while facilitating timely ε4 stratification in the era of anti-amyloid therapies.

    “In line with previous proposals of a stepwise approach [36, 37], such a model may balance analytical performance with clinical safety while facilitating timely ε4 stratification in the era of anti-amyloid therapies.”

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Research works printed but not linked: 23

  1. [1]Sims J.R. Zimmer J.A. Evans C.D. Donanemab in early symptomatic alzheimer disease: the TRAILBLAZER-ALZ 2 randomized clinical trial JAMA 330 2023 512 527 37459141 PMC10352931
  2. [2]van Dyck C.H. Sabbagh M. Cohen S. Lecanemab in early Alzheimer's disease Reply. N Engl J Med 388 2023 1631 1632 37099355
  3. [5]Bregman N. Nathan T. Shir D. Lecanemab in clinical practice: real-world outcomes in early Alzheimer's disease Alzheimers Res Ther 17 2025 119 40437535 PMC12117801
  4. [6]Paczynski M. Hofmann A. Posey Z. Lecanemab treatment in a specialty memory clinic JAMA Neurol 82 2025 655 665 40354064 PMC12070285
  5. [7]Shields L.B.E. Hust H. Cooley S.D. Initial experience with lecanemab and lessons learned in 71 patients in a regional medical center J Prev Alzheimers Dis 11 2024 1549 1562 39559868 PMC11573839
  6. [9]Rabinovici G.D. Selkoe D.J. Schindler S.E. Donanemab: appropriate use recommendations J Prev Alzheimers Dis 12 2025 100150 PMC12180672 40155270
  7. [10]Morris J.C. The clinical dementia rating (CDR): current version and scoring rules Neurology 43 1993 2412 2414 8232972
  8. [11]Magni E. Binetti G. Bianchetti A. Rozzini R. Trabucchi M. Mini-mental state examination: a normative study in Italian elderly population Eur J Neurol 3 1996 198 202 21284770
  9. [13]Galasko D. Bennett D. Sano M. An inventory to assess activities of daily living for clinical trials in Alzheimer's disease. The Alzheimer's disease cooperative study Alzheimer Dis Assoc Disord 11 Suppl 2 1997 S33 S39 9236950
  10. [14]Frisoni G.B. Festari C. Massa F. European intersocietal recommendations for the biomarker-based diagnosis of neurocognitive disorders Lancet Neurol 23 2024 302 312 38365381
  11. [15]Jack C.R. Jr. Andrews J.S. Beach T.G. Revised criteria for diagnosis and staging of Alzheimer's disease: Alzheimer's association workgroup Alzheimer's Dement 20 2024 5143 5169 38934362 PMC11350039
  12. [16]Donohue M.C. Sperling R.A. Petersen R. Association between elevated brain amyloid and subsequent cognitive decline among cognitively normal persons JAMA 317 2017 2305 2316 28609533 PMC5736301
  13. [17]Sperling R.A. Donohue M.C. Rissman R.A. Amyloid and tau prediction of cognitive and functional decline in unimpaired older individuals: longitudinal data from the A4 and LEARN studies J Prev Alzheimers Dis 11 2024 802 813 39044488 PMC11266444
  14. [18]Cogswell P.M. Andrews T.J. Barakos J.A. Alzheimer disease anti-amyloid immunotherapies: imaging recommendations and practice considerations for monitoring of amyloid-related imaging abnormalities AJNR Am J Neuroradiol 46 2025 24 32 39179297 PMC11735439
  15. [20]Zimmer J.A. Ardayfio P. Wang H. Amyloid-related imaging abnormalities with donanemab in early symptomatic alzheimer disease: secondary analysis of the TRAILBLAZER-ALZ and ALZ 2 randomized clinical trials JAMA Neurol 82 2025 461 469 40063015 PMC11894547
  16. [21]Filippi M. Cecchetti G. Spinelli E.G. Vezzulli P. Falini A. Agosta F. Amyloid-related imaging abnormalities and beta-amyloid-targeting antibodies: a systematic review JAMA Neurol 79 2022 291 304 35099507
  17. [22]Wang H. Nery E.S.M. Ardayfio P. The effect of modified donanemab titration on amyloid-related imaging abnormalities with edema/effusions and amyloid reduction: 18-month results from TRAILBLAZER-ALZ 6 J Prev Alzheimers Dis 12 2025 100266 PMC12413699 40619285
  18. [23]Wang H. Serap Monkul Nery E. Ardayfio P. Modified titration of donanemab reduces ARIA risk and maintains amyloid reduction Alzheimer's Dement 21 2025 e70062 PMC11963282 40172303
  19. [24]Mervosh N. Bilici N. Wisniewski T. Devi G. Reducing ARIA risk in Alzheimer's disease: Real-world impact of APOE genotype-guided slow titration with aducanumab and lecanemab J Alzheimers Dis 107 2025 1400 1403 40801838
  20. [25]Gueorguieva I. Chow K. Chua L. Donanemab exposure-response in early symptomatic Alzheimer's disease Alzheimer's Dement 21 2025 e70491 PMC12265020 40667684
  21. [26]La Joie R. Cummings J.L. Dage J.L. Treatment-related amyloid clearance (TRAC): a framework to characterize patients in the era of anti-amyloid therapies Alzheimer's Dement 21 2025 e70997 PMC12657122 41298245
  22. [27]Arai H. Aiba S. Arai R. Safety of switching from lecanemab to donanemab in 20 consecutive patients with Alzheimer's disease J Alzheimers Dis 107 2025 494 495 40708311
  23. [28]Perneczky R. Darby D. Frisoni G.B. Real-world datasets for the International Registry for Alzheimer’s Disease and Other Dementias (InRAD) and other registries: An international consensus J Prev Alzheimers Dis 12 4 2025 100096 10.1016/j.tjpad.2025.100096 39971671 PMC12183950 · DOI

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Authors
Filippi, M., Cecchetti, G., Spinelli, E. G., Ghirelli, A., Rugarli, G., Pisano, S., Canu, E., & Agosta, F.
Affiliations
  • Vita-Salute San Raffaele University (IT)
  • IRCCS Ospedale San Raffaele (IT)
Corresponding author
  • Filippi, Massimo
  • Cecchetti, Giordano
  • Spinelli, Edoardo G.
  • Ghirelli, Alma
  • Rugarli, Giulia
  • Pisano, Stefano
  • Canu, Elisa
  • Agosta, Federica
Venue
The Lancet Regional Health - Europe
Publisher
Elsevier BV
Published
2026-05
Volume
64
Pages
101609
ISSN
2666-7762 (ISSN-L)
OpenAlex
W7128697594
Cited by
14
References
1
Citations by year
2026: 14
FWCI
52.53
Type
journal article
Language
en
Open access
Locations
  • The Lancet Regional Health - Europe (publishedVersion, cc-by-nc-nd)
  • PubMed (publishedVersion)
  • PubMed Central (publishedVersion, cc-by-nc-nd)
  • Archivio Istituzionale della Ricerca - Università Vita-Salute San Raffaele (submittedVersion, cc-by-nc-nd)
Funders
  • Alzheimer's Disease Research Foundation
  • European Research Council
  • Ministero dell'Università e della Ricerca
  • EU Joint Programme – Neurodegenerative Disease Research
  • Ministero della Salute
Topics
  • Health Sciences › Medicine › Physiology › Alzheimer's disease research and treatments
  • Health Sciences › Medicine › Psychiatry and Mental health › Dementia and Cognitive Impairment Research
  • Health Sciences › Medicine › Pharmacology › Cholinesterase and Neurodegenerative Diseases
Keywords
Alzheimer's disease, anti-amyloid monoclonal antibodies, lecanemab, donanemab, disease-modifying therapy, patient selection, amyloid-related imaging abnormalities, MRI surveillance, shared decision-making, real-world registry, tertiary care hospital

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