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Novel Alzheimer’s Antibody Moves to Phase III After 90% Plaque Clearance

Phase III trials are under way to assess whether rapid plaque removal translates into cognitive improvement, with separate studies evaluating its preventive potential.

Overview

  • Phase II data from 149 patients showed trontinemab cleared amyloid plaques in over 90% of participants within 28 weeks
  • Fewer than 5% of participants experienced amyloid-related imaging abnormalities and all cases resolved quickly
  • An 18-month, 1,600-patient phase III trial has commenced to determine if plaque clearance yields memory and functional benefits
  • Parallel prevention studies are evaluating trontinemab’s ability to ward off Alzheimer’s in asymptomatic individuals
  • Engineered to cross the blood-brain barrier at low doses, trontinemab requires fewer infusions and less monitoring, although an earlier fatal brain hemorrhage underscores ongoing safety oversight