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Peer-reviewedCC BY 4.0Alzheimer's & Dementia

Real‐world clinical, biomarker, and imaging outcomes of lecanemab in Alzheimer's disease: a multicenter longitudinal cohort study in Jiangsu, China

  • Limoran Tang1,2
  • Xicheng Chen3
  • Li Zhang4
  • Lin Fan5
  • Nihong Chen6
  • Chaosheng Li7
  • Zenglin Cai8
  • Guofang Chen9
  • Haifeng Chen1
  • Min Ye10
  • Huifen Zheng11
  • Qi Li1
22 more authors
  • Zhihong Ke1
  • Zheqi Hu1
  • Maohong Cao12
  • Dan Yang1
  • Shuai Xu1
  • Chunming Xie13
  • Xiaobo Li14
  • Xiaotian Xu15
  • Ming Yu16
  • Xuegan Lian17
  • Hua Hu18
  • Hongfei Li19
  • Xiuying Cai20
  • Hong Chen21
  • Wu Xu22
  • Guiyun Cui23
  • Yang Zhao3
  • Jingde Dong4
  • Lili Zhang7
  • Xiaolei Zhu1,2,24,25,26,27
  • Hui Zhao1
  • Yun Xu1,2,24,25,26,27
27 affiliations
  1. 1Department of Neurology Nanjing Drum Tower Hospital, Affiliated Hospital of Medical School, Nanjing University Nanjing China
  2. 2Jiangsu Stroke Association Nanjing Jiangsu China
  3. 3Department of Biostatistics School of Public Health Nanjing Medical University Nanjing Jiangsu China
  4. 4Department of Geriatrics Nanjing Brain Hospital affiliated to Nanjing Medical University Nanjing China
  5. 5Department of Neurology Taizhou School of Clinical Medicine The Affiliated Taizhou People's Hospital of Nanjing Medical University Nanjing Medical University Taizhou Jiangsu China
  6. 6Department of Neurology Nanjing First Hospital Nanjing Medical University Nanjing China
  7. 7Department of Neurology Affiliated Hospital of Jiangnan University Wuxi Jiangsu China
  8. 8Department of Neurology The Affiliated Suzhou Hospital of Nanjing University Medical School Suzhou China
  9. 9Department of Neurology Xuzhou Central Hospital Jiangsu China
  10. 10Department of Neurology BENQ Medical Center Nanjing China
  11. 11Department of Neurology Geriatric Hospital of Nanjing Medical University Nanjing China
  12. 12Department of Neurology Affiliated Hospital of Nantong University Nantong China
  13. 13Department of Neurology Affiliated ZhongDa Hospital, School of Medicine, Southeast University Nanjing Jiangsu China
  14. 14Department of Neurology Affiliated Subei People's Hospital Yangzhou University Yangzhou China
  15. 15Department of Neurology The Affiliated Hospital of Yangzhou University Yangzhou China
  16. 16Department of Neurology The Affiliated Hospital of Jiangsu University Zhenjiang Jiangsu China
  17. 17Department of Neurology The Third Affiliated Hospital of Soochow University Changzhou Jiangsu China
  18. 18Department of Neurology The Second Affiliated Hospital of Soochow University Suzhou China
  19. 19Department of Neurology The Fourth Affiliated Hospital of Nanjing Medical University Nanjing Jiangsu China
  20. 20Department of Neurology The First Affiliated Hospital of Soochow University Suzhou Medical College of Soochow University Suzhou China
  21. 21Department of Neurology Nanjing First Hospital Nanjing Medical University Nanjing Jiangsu China
  22. 22Department of Neurology The Taixing People's Hospital Taixing China
  23. 23Department of Neurology Affiliated Hospital of Xuzhou Medical University Xuzhou Jiangsu China
  24. 24State Key Laboratory of Pharmaceutical Biotechnology and Institute of Translational Medicine for Brain Critical Diseases Nanjing University Nanjing China
  25. 25Center for Central Nervous Diseases and Neuroscience in Nanjing Drum Tower Hospital Nanjing China
  26. 26Nanjing Key Laboratory for Cardiovascular Information and Health Engineering Medicine Nanjing China
  27. 27Nanjing Neurology Clinical Medical Centre, and Centre for Central Nervous Disease and Neuroscience Nanjing China
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Abstract

INTRODUCTION: Real‐world data on lecanemab's efficacy and the longitudinal dynamics of plasma biomarkers are scarce in Chinese patients with Alzheimer's disease (AD).

METHODS: In this multicenter cohort study, 181 AD patients received biweekly lecanemab. Disease‐stage‐specific Clinical Dementia Rating–Sum of Boxes meaningful within‐patient change defined response at Months 3, 6, and 12. We used penalized models, receiver operating characteristic analysis, attrition comparisons, and exploratory Month 3 plasma biomarker analysis.

RESULTS: Cognitive response emerged at Month 6 and intensified by Month 12, largely restricted to mild cognitive impairment and mild dementia due to AD. Repeated five‐fold cross‐validated areas under the curve across the follow‐up timepoints were 0.560, 0.747, and 0.773, with apolipoprotein E ε4 positivity and more severe cognitive impairment linked to lower response odds. Plasma phosphorylated tau 217 (p‐tau217) and amyloid beta (Aβ) 42/40 altered as early as Month 3. Month 3 Aβ42/40 showed modest exploratory discrimination. The incidence of amyloid‐related imaging abnormalities was 7.2%, all asymptomatic.

DISCUSSION: Lecanemab is effective and safe in AD over 6 to 12 months. Early biomarker changes (p‐tau217, Aβ42/40) precede clinical improvement, serving as scalable response indicators.

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Cite

BibTeXRIS
BibTeX
@article{tang2026realworld,
  title = {{Real‐world clinical, biomarker, and imaging outcomes of lecanemab in Alzheimer's disease: a multicenter longitudinal cohort study in Jiangsu, China}},
  author = {Limoran Tang and Xicheng Chen and Li Zhang and Lin Fan and Nihong Chen and Chaosheng Li and Zenglin Cai and Guofang Chen and Haifeng Chen and Min Ye and Huifen Zheng and Qi Li and Zhihong Ke and Zheqi Hu and Maohong Cao and Dan Yang and Shuai Xu and Chunming Xie and Xiaobo Li and Xiaotian Xu and Ming Yu and Xuegan Lian and Hua Hu and Hongfei Li and Xiuying Cai and Hong Chen and Wu Xu and Guiyun Cui and Yang Zhao and Jingde Dong and Lili Zhang and Xiaolei Zhu and Hui Zhao and Yun Xu},
  journal = {Alzheimer's \& Dementia},
  year = {2026},
  month = oct,
  doi = {10.1002/alz.71936},
  url = {https://doi.org/10.1002/alz.71936},
  note = {CC BY 4.0},
}
RIS
TY  - JOUR
TI  - Real‐world clinical, biomarker, and imaging outcomes of lecanemab in Alzheimer's disease: a multicenter longitudinal cohort study in Jiangsu, China
AU  - Limoran Tang
AU  - Xicheng Chen
AU  - Li Zhang
AU  - Lin Fan
AU  - Nihong Chen
AU  - Chaosheng Li
AU  - Zenglin Cai
AU  - Guofang Chen
AU  - Haifeng Chen
AU  - Min Ye
AU  - Huifen Zheng
AU  - Qi Li
AU  - Zhihong Ke
AU  - Zheqi Hu
AU  - Maohong Cao
AU  - Dan Yang
AU  - Shuai Xu
AU  - Chunming Xie
AU  - Xiaobo Li
AU  - Xiaotian Xu
AU  - Ming Yu
AU  - Xuegan Lian
AU  - Hua Hu
AU  - Hongfei Li
AU  - Xiuying Cai
AU  - Hong Chen
AU  - Wu Xu
AU  - Guiyun Cui
AU  - Yang Zhao
AU  - Jingde Dong
AU  - Lili Zhang
AU  - Xiaolei Zhu
AU  - Hui Zhao
AU  - Yun Xu
PY  - 2026
DA  - 2026/10/26
JO  - Alzheimer's & Dementia
DO  - 10.1002/alz.71936
UR  - https://doi.org/10.1002/alz.71936
AB  - INTRODUCTION: Real‐world data on lecanemab's efficacy and the longitudinal dynamics of plasma biomarkers are scarce in Chinese patients with Alzheimer's disease (AD).  METHODS: In this multicenter cohort study, 181 AD patients received biweekly lecanemab. Disease‐stage‐specific Clinical Dementia Rating–Sum of Boxes meaningful within‐patient change defined response at Months 3, 6, and 12. We used penalized models, receiver operating characteristic analysis, attrition comparisons, and exploratory Month 3 plasma biomarker analysis.  RESULTS: Cognitive response emerged at Month 6 and intensified by Month 12, largely restricted to mild cognitive impairment and mild dementia due to AD. Repeated five‐fold cross‐validated areas under the curve across the follow‐up timepoints were 0.560, 0.747, and 0.773, with apolipoprotein E ε4 positivity and more severe cognitive impairment linked to lower response odds. Plasma phosphorylated tau 217 (p‐tau217) and amyloid beta (Aβ) 42/40 altered as early as Month 3. Month 3 Aβ42/40 showed modest exploratory discrimination. The incidence of amyloid‐related imaging abnormalities was 7.2%, all asymptomatic.  DISCUSSION: Lecanemab is effective and safe in AD over 6 to 12 months. Early biomarker changes (p‐tau217, Aβ42/40) precede clinical improvement, serving as scalable response indicators.
SN  - 1552-5260
SN  - 1552-5279
ER  -