Efficacy and Safety of Lecanemab in Treating Alzheimer's Disease: A Real‐World Study in South China
Year: 2025
Type: article
Abstract: BACKGROUND: Lecanemab is the only monoclonal antibody currently available that targets soluble amyloid-beta (Aβ) protofibrils. It was introduced in China in 2024, but its real-world efficacy remains to be demonstrated. This study aims to evaluate the efficacy and safety of Lecanemab in real-world practice in South China. METHOD: This was an 18-month, multicenter, single-arm, open-label, prospective observational study conducted across 25 centers. We plan to recruit 500 patients aged 50 to 90 years with mild to moderate AD within 1 year. Participants were treated with Lecanemab (10 mg/kg) biweekly. Evaluations included neuropsychological assessments, plasma biomarkers (Aβ42, Aβ40, GFAP, t-Tau, p-Tau217, p-Tau181, GFAP using Simoa), and other laboratory tests. Amyloid-Related Imaging Abnormalities (ARIA) were assessed using magnetic resonance imaging (MRI). RESULT: A total of 160 participants were recruited (58.75% female, 41.25% male) as of January, 2025, with a mean age of 68.8 ± 9.1 years. Baseline Mini-Mental State Examination (MMSE) score was 17.3 ± 6.5, Clinical Dementia Rating-Sum of Boxes (CDR-SB) score was 5.8 ± 3.6. Regarding APOE ε4 status, 55.63% were carriers, including 18 homozygotes (11.25%). As of now, 21 participants have completed two blood biomarker tests. The baseline levels of blood biomarkers included Aβ42(3.54 ± 2.30 mmol/L), Aβ40( 88.93 ± 39.67 mmol/L), Aβ42/40(0.039 ± 0.014), GFAP(234.84 ± 161.76 mmol/L), and p-Tau217( 0.99 ± 0.55mmol/L). At 14 weeks, biomarkers showed some improvement: Aβ42(5.71 ± 2.68 mmol/L), Aβ40(144.08 ± 46.86 mmol/L), Aβ42/40(0.037 ± 0.009), GFAP(215.38 ± 144.42mmol/L) and p-Tau217( 0.92 ± 0.41 mmol/L). The most common adverse events were infusion-related reactions (22.5%), and ARIA occurred in 15 cases (10.0%), with only 6 cases being symptomatic. CONCLUSION: Lecanemab was generally well-tolerated and the improvements in blood biomarkers suggest that it may have a beneficial impact on disease progression.
Source: Alzheimer s & Dementia
Institutions: Second Affiliated Hospital of Guangzhou Medical University, Jinan University, First Affiliated Hospital of Jinan University, Guangzhou First People's Hospital, South China University of Technology, Sun Yat-sen University, Zhujiang Hospital, Southern Medical University, Southern University of Science and Technology, ShenZhen People’s Hospital, The First People's Hospital of Shunde, Guangdong Provincial People's Hospital, Shenzhen University, Guangdong Medical College, Dongguan People’s Hospital
Language: English
Subfield: Physiology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,200
OpenAlex ID: W7117326969
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