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Background <p>Anti-amyloid monoclonal antibodies are entering clinical practice for early symptomatic Alzheimer’s disease (AD), but European real-world data on feasibility, safety, and biomarker monitoring remain limited. We report the first year of implementation of lecanemab and donanemab in an Italian tertiary memory center.</p> Methods <p>We conducted a prospective observational real-world cohort study at the Center for Alzheimer’s and Related Diseases of IRCCS Ospedale San Raffaele (Milan, Italy). Twenty-nine treatment courses were administered in patients with early symptomatic AD (lecanemab, <i>n</i> = 9; donanemab, <i>n</i> = 20) under European Medicines Agency–aligned safety monitoring and risk-mitigation protocols. Given the unbalanced treatment groups, results are descriptive and not intended for direct comparison between treatments. Safety surveillance included serial magnetic resonance imaging for amyloid-related imaging abnormalities (ARIA) and systematic recording of infusion-related reactions. Biological monitoring included amyloid positron emission tomography with Centiloid quantification and plasma biomarkers (phosphorylated tau 181 and 217, glial fibrillary acidic protein, neurofilament light chain, and amyloid-β 42/40 ratio) at baseline and follow-up. Baseline comparisons and longitudinal changes were assessed using appropriate parametric or nonparametric statistical methods.</p> Results <p>ARIA were infrequent. In donanemab-treated patients, mildly symptomatic ARIA-E occurred in 10% (2/20) and asymptomatic ARIA-H in 15% (3/20). In lecanemab-treated patients, asymptomatic ARIA-H occurred in 11% (1/9). Infusion-related reactions occurred in 21% (6/29) of treatment courses and were manageable with standardized premedication. Among 11 patients with six-month follow-up, amyloid burden decreased significantly (mean change − 52.4 Centiloids), and 75% of donanemab-treated patients (6/8) and 0% of lecanemab-treated patients reached amyloid positron emission tomography negativity (&lt; 11CL). Plasma phosphorylated tau 181 and glial fibrillary acidic protein showed directional declines, consistent with expected biomarker trajectories under anti-amyloid therapy, while cognitive measures showed no significant change.</p> Conclusions <p>In a structured multidisciplinary framework, lecanemab and donanemab were feasibly implemented with a preliminary favorable early safety profile, substantial amyloid reduction, and measurable plasma biomarker changes in routine practice. This experience supports the feasibility of structured real-world pathways for deployment and monitoring of disease-modifying therapies in European memory clinics, within the limitations of a small cohort and short follow-up.</p>

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Real-world implementation of lecanemab and donanemab in an Italian memory center: a 1-year experience

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月20日

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  • Federica Agosta,
  • Giordano Cecchetti,
  • Edoardo G. Spinelli,
  • Alma Ghirelli,
  • Giulia Rugarli,
  • Stefano Pisano,
  • Federico Coraglia,
  • Elisa Canu,
  • Veronica Castelnovo,
  • Elisa Sibilla,
  • Anna Gilioli,
  • Chiara Tripodi,
  • Fabiola Freri,
  • Alessandra Bianchi,
  • Paolo Vezzulli,
  • Sonia Calloni,
  • Andrea Falini,
  • Ana Maria Samanes Gajate,
  • Andrea Panzacchi,
  • Gino Pepe,
  • Camilla Ferri,
  • Arturo Chiti,
  • Massimo Filippi

摘要

Background

Anti-amyloid monoclonal antibodies are entering clinical practice for early symptomatic Alzheimer’s disease (AD), but European real-world data on feasibility, safety, and biomarker monitoring remain limited. We report the first year of implementation of lecanemab and donanemab in an Italian tertiary memory center.

Methods

We conducted a prospective observational real-world cohort study at the Center for Alzheimer’s and Related Diseases of IRCCS Ospedale San Raffaele (Milan, Italy). Twenty-nine treatment courses were administered in patients with early symptomatic AD (lecanemab, n = 9; donanemab, n = 20) under European Medicines Agency–aligned safety monitoring and risk-mitigation protocols. Given the unbalanced treatment groups, results are descriptive and not intended for direct comparison between treatments. Safety surveillance included serial magnetic resonance imaging for amyloid-related imaging abnormalities (ARIA) and systematic recording of infusion-related reactions. Biological monitoring included amyloid positron emission tomography with Centiloid quantification and plasma biomarkers (phosphorylated tau 181 and 217, glial fibrillary acidic protein, neurofilament light chain, and amyloid-β 42/40 ratio) at baseline and follow-up. Baseline comparisons and longitudinal changes were assessed using appropriate parametric or nonparametric statistical methods.

Results

ARIA were infrequent. In donanemab-treated patients, mildly symptomatic ARIA-E occurred in 10% (2/20) and asymptomatic ARIA-H in 15% (3/20). In lecanemab-treated patients, asymptomatic ARIA-H occurred in 11% (1/9). Infusion-related reactions occurred in 21% (6/29) of treatment courses and were manageable with standardized premedication. Among 11 patients with six-month follow-up, amyloid burden decreased significantly (mean change − 52.4 Centiloids), and 75% of donanemab-treated patients (6/8) and 0% of lecanemab-treated patients reached amyloid positron emission tomography negativity (< 11CL). Plasma phosphorylated tau 181 and glial fibrillary acidic protein showed directional declines, consistent with expected biomarker trajectories under anti-amyloid therapy, while cognitive measures showed no significant change.

Conclusions

In a structured multidisciplinary framework, lecanemab and donanemab were feasibly implemented with a preliminary favorable early safety profile, substantial amyloid reduction, and measurable plasma biomarker changes in routine practice. This experience supports the feasibility of structured real-world pathways for deployment and monitoring of disease-modifying therapies in European memory clinics, within the limitations of a small cohort and short follow-up.