Anti-Amyloid Therapy Status — RACP Adult Medicine MCQ
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Correct answer: E — Not yet TGA-approved in Australia
As of early 2026, lecanemab and donanemab (anti-amyloid monoclonal antibodies that showed modest cognitive benefit in early AD in the CLARITY AD and TRAILBLAZER-ALZ 2 trials) have received regulatory consideration but are NOT yet widely approved and PBS-listed in Australia. Their use is restricted to early symptomatic AD (MCI or mild dementia) with PET or CSF confirmed amyloid pathology. Side effects include amyloid-related imaging abnormalities (ARIA – brain oedema and microhaemorrhages), requiring regular MRI monitoring.
Reference: TGA – 2025 – Anti-Amyloid Antibody Status; eTG – 2025 – Neurology