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Related Experiment Video

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Dried Blood Spot Collection of Health Biomarkers to Maximize Participation in Population Studies
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Biomarkers.

Alexander Andrew Wallace1,2, Oliver Zhou1,2, CIndy Marshall3

  • 1Texas A&M College of Medicine, Dallas, TX, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary
This summary is machine-generated.

Real-world data show that amyloid-related imaging abnormalities (ARIA) incidence and characteristics in Alzheimer's disease (AD) patients treated with lecanemab mirror clinical trial results. This supports lecanemab's safety profile in routine clinical practice.

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Area of Science:

  • Neurology
  • Pharmacology
  • Radiology

Background:

  • Amyloid-related imaging abnormalities (ARIA), including brain edema (ARIA-E) and hemorrhage (ARIA-H), are known side effects of anti-amyloid therapies like lecanemab.
  • Understanding the real-world safety profile of lecanemab is crucial for informed clinical decision-making regarding Alzheimer's disease (AD) treatment.
  • Limited real-world safety data exist for lecanemab despite its demonstrated efficacy in clinical trials.

Purpose of the Study:

  • To evaluate the incidence and characteristics of ARIA in patients with AD receiving lecanemab in a real-world clinical setting.
  • To compare real-world ARIA data with findings from the CLARITY-AD clinical trial.
  • To assess the association between ARIA and APOE genotype in patients treated with lecanemab.

Main Methods:

  • Retrospective chart review of 146 patients with AD treated with lecanemab.
  • Analysis of post-treatment MRI scans to identify ARIA, ARIA-E, and ARIA-H.
  • Comparison of real-world ARIA data with CLARITY-AD trial data, including APOE genotype analysis.

Main Results:

  • Real-world ARIA incidence and characteristics closely mirrored those observed in the CLARITY-AD trial.
  • No statistically significant differences were found in ARIA, ARIA-E, ARIA-H, or symptomatic ARIA rates between real-world data and the CLARITY-AD trial.
  • APOE genotype did not show a statistically significant association with ARIA development or severity in this real-world cohort.

Conclusions:

  • Real-world data on ARIA incidence, severity, and APOE genotype associations align with CLARITY-AD trial findings.
  • These findings provide further evidence supporting the overall safety of lecanemab in routine clinical practice.
  • Lecanemab treatment for AD can be safely managed in clinical practice when guided by appropriate use recommendations.