On October 10, 2025, the team led by Professors Liu Jun and Kang Wenyan from the Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, published an article online titled "Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer’s disease: Evidence from a Multidimensional Real-World Study.” The study was published in Volume 138, Issue 22 of the Chinese Medical Journal on November 20, 2025. This study is the first real-world study of lecanemab conducted in China, and also a valuable scientific research achievement from the integrated operation of Shanghai Ruijin Hospital and Hainan Branch of Ruijin Hospital under the special policy of Hainan Boao Lecheng International Medical Tourism Pilot Zone.
As a fatal neurodegenerative disease, Alzheimer’s disease (AD) affects approximately 55 million people worldwide, with nearly 10 million patients in China. Along the disease progresses, patients gradually lose cognitive and behavioral abilities. Before the advent of disease-modifying therapy (DMT) drugs, AD was mainly treated with symptomatic therapy, lacking effective methods to slow down the progression of the disease.
In September 2023, lecanemab, an amyloid-targeted drug for Alzheimer’s disease, was launched in the Lecheng Pilot Zone. It can specifically clear the toxic amyloid-beta (Aβ) protein that causes the occurrence and development of Alzheimer’s disease and slow down the disease progression, making it the first drug for the etiological treatment of Alzheimer’s disease.
As the first real-world exploration of lecanemab in Chinese patients with early AD, this study fills the evidence gap between "international clinical trial data" and "clinical practice in the Chinese population". As China’s first real-world evaluation of lecanemab under the "pilot first" policy, the study provides important references for the safety and preliminary effectiveness of lecanemab in patients with mild cognitive impairment (MCI) and mild AD， and is of great value for guiding future clinical practice and establishing long-term monitoring strategies.
In terms of results, the safety data is particularly striking: 20.3% of infusion-related reactions were mainly mild, and more than 80% did not occur again. The incidence of amyloid-related imaging abnormalities-microhemorrhages/superficial siderosis (ARIA-H) and amyloid-related imaging abnormalities-edema/effusion (ARIA-E) are 9.4% and 3.1%, respectively, only two cases are symptomatic. This rate is lower than in the international multicenter Clarity AD study and is basically consistent with the Asian data. The reasons may be related to the low proportion of apolipoprotein E ε4 (APOE ε4) homozygotes in the included population, low usage rate of antithrombotic drugs, and short observation time. In terms of efficacy, the 6-month cognitive scores (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], and clinical dementia rating–sum of boxes [CDR-SB]) remained stable. Aβ-positron emission tomography (Aβ-PET) showed a continuous reduction in brain Aβ deposition after lecanemab treatment, confirming the efficacy of lecanemab in slowing down cognitive decline and clearing brain Aβ deposition in Chinese patients with early AD.
This study provides key support for the "from guideline to implementation" of AD diagnosis and treatment in China. Different from clinical trials with strictly controlled inclusion and exclusion criteria, the patients included in this real-world study are more in line with actual clinical practice. Innovatively, this study also incorporates "cognitive scales + plasma biomarkers + neuroimaging" into a multidimensional evaluation system. It not only follows the international cutting-edge standards for AD diagnosis and treatment, but also fully takes into account the current situation in China’s clinical practice, such as the improved accessibility of imaging technology and the upcoming popularization of plasma testing. Against the background of uneven distribution of AD diagnosis and treatment resources in China, this localized safety and effectiveness data can help more clinicians build confidence in the use of lecanemab and is more practical for guiding in non-specialized institutions such as primary hospitals. It promotes the concept of "early intervention" for AD from theory to practice and lays a foundation for the subsequent formulation of AD treatment plans suitable for the characteristics of the Chinese population.
Reference
DOI: https://doi.org/10.1097/cm9.0000000000003888
About the authors
Corresponding authors
- Liu Jun: Changjiang Distinguished Professor, Chief Physician, Doctoral Supervisor, Department Director, Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Tang Yonghua: Doctor, Associate Chief Physician, Department of Radiology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine; Department of Radiology, Hainan Branch of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
First authors
- Kang Wenyan: Doctor, Chief Physician, Master Supervisor, Cooperative Postdoctoral Supervisor, Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Gao Chao: Doctor, Resident Physician, Department of Neurology, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
- Li Xiaoyan: Master, Resident Physician, Department of Neurology, Hainan Branch of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Funding information
This study was supported by grants from the Hainan Province Science and Technology Special Fund (No. ZDYF2024LCLH005), National Natural Science Foundation of China (No. 82101477), and the 2025 Shanghai Natural Science Foundation (No. 25ZR1402333).
Chinese Medical Journal
Randomized controlled/clinical trial
People
Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer’s disease: Evidence from a multidimensional real-world study
20-Nov-2025