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Background and objectives <p>Lecanemab (Leqembi®) has been approved for the treatment of early Alzheimer’s disease (AD) patients. However, the safety and efficacy of lecanemab in clinical practice in Asia population remain unclear.</p> Design, setting, and participants <p>This prospective cohort study was conducted in a single center in Eastern China, including 76 early-stage AD participants treated with lecanemab. All participants underwent at least 1 lecanemab infusion.</p> Results <p>The mean age was 66&#xa0;years (65.53 ± 9.31), and 51 (67.1%) participants being female. A total of 49 (64.5%) participants were <i>ApoE</i>-<i>ε4</i> carriers, including 34 (44.7%) heterozygotes and 15 (19.7%) homozygotes. Infusion-related side effects (IRSE), primarily occurred after the first infusion, were observed in 14 participants (18.4%). The most common IRSE were fever and fatigue. Until 9 Aug 2025, 58 participants had received treatment for more than 3&#xa0;months, 44 for more than 6&#xa0;months and 12 for more than 12&#xa0;months. Amyloid-related imaging abnormalities (ARIA) were observed in 11 participants. Specifically, solitary ARIA-H (hemorrhage) was detected in 7 participants, while ARIA-E (edema) with or without cerebral micro-hemorrhage was identified in 4. Notably, all the 11 participants with ARIA were asymptomatic. Participants with isolated ARIA-H exhibited higher baseline Fazekas scores of PVWMHs (<i>p</i> = 0.008). Participants with a Clinical Dementia Rating Scale Global Score (CDR-GS) of 1 had a more rapid decline in Mini-Mental State Global Score (MMSE) scores as compared to those with a CDR-GS of 0.5. Following 12&#xa0;months of lecanemab therapy, amyloid PET exhibited a significant reduction in brain amyloid burden.</p> Conclusion <p>These data support that lecanemab appears to be generally tolerated in Asian population. The IRSE and ARIA-E events were less common than the Clarity AD study.</p>

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Real—world application of lecanemab in early—stage alzheimer's disease: a single—center prospective cohort analysis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年11月17日

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  • Jia Shang,
  • Siyan Zhong,
  • Li Shang,
  • Qingze Zeng,
  • Shuai Zhao,
  • Xiao Luo,
  • Kaicheng Li,
  • Xinyi Zhang,
  • Peiyu Huang,
  • Yaping Yan,
  • Zhirong Liu,
  • Baorong Zhang,
  • Yanxing Chen

摘要

Background and objectives

Lecanemab (Leqembi®) has been approved for the treatment of early Alzheimer’s disease (AD) patients. However, the safety and efficacy of lecanemab in clinical practice in Asia population remain unclear.

Design, setting, and participants

This prospective cohort study was conducted in a single center in Eastern China, including 76 early-stage AD participants treated with lecanemab. All participants underwent at least 1 lecanemab infusion.

Results

The mean age was 66 years (65.53 ± 9.31), and 51 (67.1%) participants being female. A total of 49 (64.5%) participants were ApoE-ε4 carriers, including 34 (44.7%) heterozygotes and 15 (19.7%) homozygotes. Infusion-related side effects (IRSE), primarily occurred after the first infusion, were observed in 14 participants (18.4%). The most common IRSE were fever and fatigue. Until 9 Aug 2025, 58 participants had received treatment for more than 3 months, 44 for more than 6 months and 12 for more than 12 months. Amyloid-related imaging abnormalities (ARIA) were observed in 11 participants. Specifically, solitary ARIA-H (hemorrhage) was detected in 7 participants, while ARIA-E (edema) with or without cerebral micro-hemorrhage was identified in 4. Notably, all the 11 participants with ARIA were asymptomatic. Participants with isolated ARIA-H exhibited higher baseline Fazekas scores of PVWMHs (p = 0.008). Participants with a Clinical Dementia Rating Scale Global Score (CDR-GS) of 1 had a more rapid decline in Mini-Mental State Global Score (MMSE) scores as compared to those with a CDR-GS of 0.5. Following 12 months of lecanemab therapy, amyloid PET exhibited a significant reduction in brain amyloid burden.

Conclusion

These data support that lecanemab appears to be generally tolerated in Asian population. The IRSE and ARIA-E events were less common than the Clarity AD study.