Abstract
Two antiamyloid monoclonal antibodies (mAbs), lecanemab and donanemab, were recently
launched for treatment of Alzheimer's disease (AD). These mAbs remove amyloid protein
from the brain and cause statistically significant improvement in cognitive/functional
tests, meaning a change in evolution of AD. This is important to reinforce the amyloid
cascade hypothesis and to further concentrate studies on the pathways from the deposition
of the beta-amyloid protein to synaptic loss and neuronal death. However, it is necessary
to evaluate whether the results are clinically important. Analysis of the clinical
trials showed that the statistically significant differences over placebo did not
reach the minimum clinically important difference that would be meaningful for patients,
caregivers and clinicians. Besides, the incidence of adverse events is high and potentially
severe. Although there are reasons to celebrate this first step towards disease-modifying
therapies for AD, lecanemab and donanemab should not be used to treat AD in clinical
pratice.
Keywords Alzheimer Disease - Therapeutics - Antibodies, Monoclonal - Amyloid Cascade - Lecanemab
- Donanemab - Minimum Clinically Important Difference
Bibliographical Record Ricardo Nitrini, Adalberto Studart-Neto. Monoclonal antibodies against beta-amyloid
protein (lecanemab and donanemab) should not be used in the treatment of Alzheimer's
disease. Arq Neuropsiquiatr 2025; 83: s00451808082. DOI: 10.1055/s-0045-1808082