1.Safety and effectiveness of lecanemab in Chinese patients with early Alzheimer's disease: Evidence from a multidimensional real-world study.
Wenyan KANG ; Chao GAO ; Xiaoyan LI ; Xiaoxue WANG ; Huizhu ZHONG ; Qiao WEI ; Yonghua TANG ; Peijian HUANG ; Ruinan SHEN ; Lingyun CHEN ; Jing ZHANG ; Rong FANG ; Wei WEI ; Fengjuan ZHANG ; Gaiyan ZHOU ; Weihong YUAN ; Xi CHEN ; Zhao YANG ; Ying WU ; Wenli XU ; Shuo ZHU ; Liwen ZHANG ; Naying HE ; Weihuan FANG ; Miao ZHANG ; Yu ZHANG ; Huijun JU ; Yaya BAI ; Jun LIU
Chinese Medical Journal 2025;138(22):2907-2916
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.
Humans
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Alzheimer Disease/drug therapy*
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Male
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Female
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Aged
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Middle Aged
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Cognitive Dysfunction/drug therapy*
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Aged, 80 and over
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Amyloid beta-Peptides/metabolism*
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Biomarkers
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East Asian People
2.Cuscutae Semen ameliorates mepanipyrim-induced visual impairment in zebrafish via the phototransduction pathway with identification of potential active constituents
Yaling YANG ; Zihan ZHAO ; Yaqian ZHENG ; Naying ZHENG ; Lian YANG ; Anfernee Kai Wing TSE ; Zhenghong ZUO ; Chengyong HE ; Jian YANG ; Lanping GUO
Science of Traditional Chinese Medicine 2025;3(4):336-346
Background: The global rise in visual impairment, driven by population aging, the increasing prevalence of lifestyle-related chronic diseases, and environmental factors, has made it a critical public health concern, highlighting the urgent need for effective preventive strategies and eye health maintenance. Cuscutae Semen (CS), a traditional Chinese herbal medicine long regarded for its vision-enhancing properties, has been widely used to support ocular health. However, its underlying molecular mechanisms and bioactive constituents remain poorly understood, limiting its modernization and broader clinical application. Objective: This study aims to investigate the restorative effects of CS on visual impairment, elucidate its underlying mechanisms, and identify potential active components. Methods: A zebrafish model of visual impairment was established using mepanipyrim to simulate retinal structural damage and visual dysfunction. The therapeutic effects of CS were systematically evaluated through behavioral analyses and histomorphological observations. To elucidate the underlying mechanisms, an integrated approach was employed, combining transcriptome sequencing (RNA-seq), reverse transcription quantitative polymerase chain reaction validation, and immunofluorescence staining to identify critical genes and pathways involved. Furthermore, macroporous resin column chromatography was employed for the fractionation and screening of potential active components. Results: CS treatment significantly alleviated mepanipyrim-induced ocular abnormalities in zebrafish, restoring approximately 82% of the observed morphological defects. Behavioral assessments revealed that CS-treated zebrafish exhibited markedly increased swimming speed and distance, indicating enhanced visual light sensitivity. Histopathological analysis demonstrated that CS effectively repaired the structure of retinal cell layers. RNA-seq revealed that CS broadly reversed mepanipyrim-induced gene expression disturbances, suggesting a restorative effect on transcriptomic homeostasis. Gene Ontology enrichment analysis identified the phototransduction pathway as a key mediator of CS’s therapeutic effects. This was further supported by reverse transcription quantitative polymerase chain reaction validation of critical genes and immunofluorescence staining, which confirmed the restored expression of Pde6a and Gnat2, key proteins involved in photic signal transmission. Active component screening indicated that high-polar constituents, including chlorogenic acid, may constitute one of the major bioactive fractions responsible for the observed therapeutic effects. Conclusion: This study provides evidence of the vision-protective effects of CS in a zebrafish model, demonstrating that its therapeutic mechanism involves modulation of the phototransduction pathway. Chlorogenic acid was identified as one of the key bioactive constituents contributing to this effect. These findings not only provide scientific validation for the traditional use of CS in ocular protection but also present promising therapeutic prospects for the prevention and treatment of visual impairment.
3.Systemic lupus erythematosus with primary sclerosing cholangitis
Cui LU ; Jialin TENG ; Zhuochao ZHOU ; Fan WANG ; Naying HE ; Chengde YANG ; Junna YE
Chinese Journal of Rheumatology 2021;25(3):184-188,F3
Objective:To investigate the clinical manifestations, laboratory and imaging features, treatment and prognosis of systemic lupus erythematosus (SLE) with primary sclerosing cholangitis (PSC).Methods:This is a retrospective case series study describing the clinical, laboratory and imaging manife-stations, treatment and prognosis of 3 SLE patients with PSC. The related literatures were reviewed.Results:In total, 10 patients were included. SLE with PSC, with an average age of (43±17) years old, was more common with hematological and renal involvement, jaundice and arthralgia, positive anti-double-stranded DNA (anti-dsDNA) antibody, hypocomplementemia, elevated erythrocyte sedimentation rate (ESR) and abnormal liver function with predominately elevated alkaline phosphatase (ALP). The classic magnetic resonance cholangio-pancreatography (MRCP) features of PSC include multifocal strictures, beading and areas of dilatation involving the intra- and/or extrahepatic bile ducts. The treatment included glucocorticosteroids, immunosup-pressants and ursodeoxycholic acid (UDCA), and some patients required biliary drainage. Most patients had a good prognosis.Conclusion:Although PSC is rare, attention should be paid to SLE patients with abnormal liver function, especially with elevated ALP, in order to differentiate from PSC.
4.Interhemispheric functional connectivity changes in early Parkinson disease with the symptom asymmetry
Naying HE ; Huawei LING ; Kemin CHEN ; Yong ZHANG ; Bei DING ; Juan HUANG ; Fuhua YAN
Chinese Journal of Radiology 2014;48(8):621-626
Objective To investigate changes of the interhemispheric coordination integrity in patients with hemi-parkinsonism using resting-state functional magnetic resonance imaging(rs-fMRI) homotopy technique called voxel-mirrored homotopic connectivity(VMHC).Methods Sixteen Parkinson disease(PD) patients with right body side motor symptom onset(RPD),15 patients with left side onset(LPD),and 19 age-,gender-,and education-matched healthy controls(HC) were included in this study.rs-fMRI scanning and pre-processed the raw data were performed.Then by using analysis of variance(ANOVA) and two sample t tset,we performed VMHC analyses on rs-fMRI data of these participants(P<0.05,corrected with AlphaSim,clusters≥16 voxels).Exploratory linear correlations analyses were performed between the VMHC of regions showing significant group differences and the clinical features of LPD or RPD patients.Results Compared with HCs,patients with LPD had significantly reduced VMHC in visual regions,sensorimotor regions,and the cerebellar cortex(voxels size of 17-77,t=-5.06--3.42,P<0.05).Patients with RPD exhibited decreased VMHC in the prefrontal cortex and sensorimotor regions.Both LPD and RPD groups had increased VMHC in subcortical regions.When compared with the RPD group,the LPD group displayed decreased VMHC in the visual regions,sensorimotor regions(voxels=16 and 18; t=-3.68and-3.87,respectively,both P<0.05) and increased VMHC in the supramarginal gyrus(voxels=4,t=4.72,P<0.05);ROI-based correlation analyses indicated that the VMHC in the inferior occipital gyrus and the postcentral gyrus was negatively correlated with the BDI-Ⅱ scores in the LPD group(r=-0.58 and-0.59,respectively; both P<0.05),and positively correlated with the MMSE scores(r=0.56 and 0.52,respectively;both P<0.05).In the RPD group,a positive correlation was found for the VMHC in the supramarginal gyrus and the illness duration(r=0.56,P<0.05) and for the VMHC in the postcentral gyrus and the(mini-mental state exam) MMSE(r=0.53,P<0.05).Conclusions The differential pattern of deficits in the interhemispheric coordination integrity in hemi-parkinsonism reflected by VMHC may provide insights into the neurological pathophysiology underlying the asymmetry of symptom appearance in PD.

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