Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
10.1097/CM9.0000000000003888
- Author:
Wenyan KANG
1
;
Chao GAO
1
;
Xiaoyan LI
2
;
Xiaoxue WANG
3
;
Huizhu ZHONG
2
;
Qiao WEI
2
;
Yonghua TANG
4
;
Peijian HUANG
1
;
Ruinan SHEN
1
;
Lingyun CHEN
5
;
Jing ZHANG
4
;
Rong FANG
1
;
Wei WEI
6
;
Fengjuan ZHANG
6
;
Gaiyan ZHOU
6
;
Weihong YUAN
7
;
Xi CHEN
7
;
Zhao YANG
1
;
Ying WU
3
;
Wenli XU
8
;
Shuo ZHU
1
;
Liwen ZHANG
9
;
Naying HE
4
;
Weihuan FANG
4
;
Miao ZHANG
10
;
Yu ZHANG
10
;
Huijun JU
10
;
Yaya BAI
10
;
Jun LIU
1
Author Information
1. Department of Neurology, Institute of Neurology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
2. Department of Neurology, Hainan Branch, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Qionghai, Hainan 571437, China.
3. Department of Biostatistics, School of Public Health, Southern Medical University, Guangzhou, Guangdong 510515, China.
4. Department of Radiology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China.
5. Medical department, Eisai China Inc., Jing'an District, Shanghai 200400, China.
6. Neurology Department, Taicang Branch of Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Taicang, Jiangsu 215400, China.
7. Real World study Institute of Hainan Lecheng, Boao Lecheng International Medical Tourism Pilot Zone, Boao, Hainan 571437, China.
8. Nursing Ward, Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai 201801, China.
9. Institute for Medical Imaging Technology, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 201801, China.
10. Department of Nuclear Medicine, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine, Shanghai 20025, China.
- Publication Type:Journal Article
- Keywords:
Alzheimer’s disease;
Chinese;
Cognitive function;
Lecanemab;
Neuroimaging;
Plasma biomarkers;
Safety
- MeSH:
Humans;
Alzheimer Disease/drug therapy*;
Male;
Female;
Aged;
Middle Aged;
Cognitive Dysfunction/drug therapy*;
Aged, 80 and over;
Amyloid beta-Peptides/metabolism*;
Biomarkers;
East Asian People
- From:
Chinese Medical Journal
2025;138(22):2907-2916
- CountryChina
- Language:English
-
Abstract:
INTRODUCTION:Lecanemab has shown promise in treating early Alzheimer's disease (AD), but its safety and efficacy in Chinese populations remain unexplored. This study aimed to evaluate the safety and 6-month clinical outcomes of lecanemab in Chinese patients with mild cognitive impairment (MCI) or mild AD.
METHODS:In this single-arm, real-world study, participants with MCI due to AD or mild AD received biweekly intravenous lecanemab (10 mg/kg). The study was conducted at Hainan Branch, Ruijin Hospital Shanghai Jiao Tong University School of Medicine. Patient enrollment and baseline assessments commenced in November 2023. Safety assessments included monitoring for amyloid-related imaging abnormalities (ARIA) and other adverse events. Clinical and biomarker changes from baseline to 6 months were evaluated using cognitive scales (mini-mental state examination [MMSE], montreal cognitive assessment [MoCA], clinical dementia rating-sum of boxes [CDR-SB]), plasma biomarker analysis, and advanced neuroimaging.
RESULTS:A total of 64 patients were enrolled in this ongoing real-world study. Safety analysis revealed predominantly mild adverse events, with infusion-related reactions (20.3%, 13/64) being the most common. Of these, 69.2% (9/13) occurred during the initial infusion and 84.6% (11/13) did not recur. ARIA-H (microhemorrhages/superficial siderosis) and ARIA-E (edema/effusion) were observed in 9.4% (6/64) and 3.1% (2/64) of participants, respectively, with only two symptomatic cases (one ARIA-E presenting with headache and one ARIA-H with visual disturbances). After 6 months of treatment, cognitive scores remained stable compared to baseline (MMSE: 22.33 ± 5.58 vs . 21.27 ± 4.30, P = 0.733; MoCA: 16.38 ± 6.67 vs . 15.90 ± 4.78, P = 0.785; CDR-SB: 2.30 ± 1.65 vs . 3.16 ± 1.72, P = 0.357), while significantly increasing plasma amyloid-β 42 (Aβ42) (+21.42%) and Aβ40 (+23.53%) levels compared to baseline.
CONCLUSIONS:Lecanemab demonstrated a favorable safety profile in Chinese patients with early AD. Cognitive stability and biomarker changes over 6 months suggest potential efficacy, though high dropout rates and absence of a control group warrant cautious interpretation. These findings provide preliminary real-world evidence for lecanemab's use in China, supporting further investigation in larger controlled studies.
REGISTRATION:ClinicalTrials.gov , NCT07034222.
