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Drug Development.

Jin Zhou1, Erica Andreozzi1, Jorge J Llibre-Guerra2

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Lecanemab treatment in Dominantly Inherited Alzheimer's Disease (DIAD) patients was generally well-tolerated over six months. Common side effects included amyloid-related imaging abnormalities (ARIA) and infusion reactions, with most cases being mild to moderate.

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Area of Science:

  • Neurology
  • Clinical Trials
  • Pharmacology

Background:

  • Investigating therapies for Dominantly Inherited Alzheimer's Disease (DIAD).
  • Evaluating etalanetug (E2814) in combination with lecanemab.
  • Assessing lecanemab safety in DIAD patients within the DIAN-TU-001 trial.

Purpose of the Study:

  • To evaluate the 6-month safety profile of lecanemab in symptomatic DIAD participants.
  • To identify common adverse events associated with lecanemab treatment in this population.
  • To monitor for amyloid-related imaging abnormalities (ARIA) and infusion reactions.

Main Methods:

  • Phase II/III multicenter, randomized, double-blind, placebo-controlled platform trial.
  • Safety assessments included vital signs, physical exams, adverse events, lab tests, and ECGs.
  • Magnetic resonance imaging (MRI) was used to monitor ARIA occurrence.

Main Results:

  • Lecanemab was generally well-tolerated in 97 DIAD participants over 6 months.
  • Most common adverse events (AEs) were ARIA-H (26.8%), headache (25.8%), ARIA-E (20.6%), and infusion reactions (11.3%).
  • Symptomatic ARIA-E occurred in 4.1% and symptomatic ARIA-H in 1.0%; 2.06% withdrew due to ARIA.

Conclusions:

  • Lecanemab demonstrated good tolerability in the DIAD population studied.
  • ARIA-H, headache, ARIA-E, and infusion reactions were the most frequent AEs.
  • DIAD patients may exhibit higher rates of cerebral amyloid angiopathy-related ARIA.