Substantial Doubt Remains about the Efficacy of Anti-Amyloid Antibodies
- PMID: 38250779
- DOI: 10.3233/JAD-231198
Substantial Doubt Remains about the Efficacy of Anti-Amyloid Antibodies
Abstract
With the FDA approval of aducanumab and lecanemab, and with the recent statistically significant phase 3 clinical trial for donanemab, there is growing enthusiasm for anti-amyloid antibodies in the treatment of Alzheimer's disease. Here, we discuss three substantial limitations regarding recent anti-amyloid clinical trials: 1) there is little evidence that amyloid reduction correlates with clinical outcome, 2) the reported efficacy of anti-amyloid therapies may be explained by functional unblinding, and 3) donanemab had no effect on tau burden in its phase 3 trial. Taken together, these observations call into question the efficacy of anti-amyloid therapies.
Keywords: Alzheimer’s disease; amyloid; clinical trials; tau.
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