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Armen Moughamian1, Shawn Kile2, Jane Kim1

  • 1Ray Dolby Brain Health Center, Sutter Health, San Francisco, CA, USA.

Alzheimer'S & Dementia : the Journal of the Alzheimer'S Association
|December 25, 2025
PubMed
Summary
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Lecanemab, a new Alzheimer's treatment, showed lower rates of amyloid-related imaging abnormalities (ARIA) in a community setting compared to clinical trials. This suggests lecanemab can be safely administered outside specialized centers.

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Area of Science:

  • Neurology
  • Pharmacology
  • Clinical Medicine

Background:

  • Lecanemab is the first FDA-approved disease-modifying therapy for Alzheimer's disease.
  • Amyloid-related imaging abnormalities (ARIA) are a significant side effect associated with lecanemab treatment.
  • Uncertainty exists regarding the real-world frequency and severity of ARIA in clinical practice.

Purpose of the Study:

  • To summarize the experience with lecanemab treatment in a community-based healthcare system.
  • To assess the safety and tolerability of lecanemab in a real-world patient cohort.
  • To compare ARIA rates in a community setting with findings from the phase 3 CLARITY-AD trial.

Main Methods:

  • Data collected from patients receiving lecanemab between July 2023 and June 2024.
  • Eligibility determined by FDA labeling and Appropriate Use Recommendations.
  • Focus on patients with at least 6 months of lecanemab treatment to capture the highest risk period for ARIA.

Main Results:

  • 210 patients treated (mean age 75, 52% female); 70% mild cognitive impairment, 30% mild dementia.
  • 36% experienced infusion reactions (mostly mild); 14% discontinued lecanemab.
  • 15.7% experienced ARIA (13.8% ARIA-H, 7.6% ARIA-E); 8 cases of severe radiographic ARIA; 3 symptomatic ARIA cases.

Conclusions:

  • Lecanemab can be safely administered in a large community-based healthcare system.
  • Higher infusion reaction rates but lower ARIA rates observed compared to the CLARITY-AD trial.
  • Lower ARIA rates in ApoE4 non-carriers and heterozygotes suggest safe administration in community settings.