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Serious doubts about amyloid-β (Aβ) biomarkers and anti-Aβ immunotherapy - PubMed

4 hours ago
  • #Alzheimer's disease
  • #biomarkers
  • #immunotherapy
  • New Alzheimer's disease treatments using anti-amyloid-β immunotherapy are raising concerns.
  • Trials supporting lecanemab and donanemab approvals have methodological flaws.
  • Benefits may be smaller than the minimal clinically important difference or absent due to exclusion of patients with poor tolerance.
  • Treatment increases amyloid-related imaging abnormalities, suggesting local tissue damage.
  • Linked to brain volume loss.
  • Doubts about whether regulators are adequately balancing risks and benefits.