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Drug Development.

Wang Liao1, Qun Yu1, Bin Chen1

  • 1Department of Neurology, the Second Affiliated Hospital of Guangzhou Medical University, Institute of Neuroscience, the Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, Guangdong, China.

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Lecanemab treatment in South China showed generally good tolerability and positive changes in blood biomarkers for Alzheimer's disease (AD). These findings suggest Lecanemab may help slow AD progression in real-world settings.

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Area of Science:

  • Neurology
  • Pharmacology
  • Biochemistry

Background:

  • Lecanemab is a monoclonal antibody targeting soluble amyloid-beta (Aβ) protofibrils, introduced in China in 2024.
  • Real-world efficacy of Lecanemab for Alzheimer's disease (AD) in China requires demonstration.
  • This study evaluates Lecanemab's efficacy and safety in South China's real-world AD patient population.

Purpose of the Study:

  • To assess the real-world efficacy of Lecanemab in treating mild to moderate Alzheimer's disease.
  • To evaluate the safety profile of Lecanemab, including adverse events like Amyloid-Related Imaging Abnormalities (ARIA).
  • To monitor changes in key plasma biomarkers associated with AD pathology during Lecanemab treatment.

Main Methods:

  • An 18-month, multicenter, single-arm, open-label, prospective observational study.
  • Recruitment of 500 patients aged 50-90 with mild to moderate AD, treated biweekly with Lecanemab (10 mg/kg).
  • Evaluations included neuropsychological tests, plasma biomarkers (Aβ42, Aβ40, GFAP, t-Tau, p-Tau217, p-Tau181), and MRI for ARIA assessment.

Main Results:

  • 160 participants recruited by January 2025 (mean age 68.8 years); 55.63% APOE ε4 carriers.
  • At 14 weeks, improvements observed in plasma biomarkers: Aβ42, Aβ40, GFAP, and p-Tau217.
  • Most common adverse events: infusion reactions (22.5%); ARIA occurred in 10.0% (6 symptomatic).

Conclusions:

  • Lecanemab demonstrated good tolerability in a real-world South China setting.
  • Observed improvements in blood biomarkers suggest potential benefits for Alzheimer's disease progression.
  • Further real-world data will be crucial for confirming Lecanemab's long-term impact on AD.