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Lecanemab effective against Alzheimer's disease - strong support for the toxic role of amyloid

The results of a global phase 3 clinical trial of lecanemab, a new treatment for Alzheimer's disease, have been published in a press release. The results are favourable and the marketing application will soon be submitted to the European and US health authorities.

Lecanemab is an experimental anti-amyloid antibody that aims to clear the brain of soluble fibrillar forms of the beta-amyloid protein associated with Alzheimer's disease. The removal of beta-amyloid has been shown to result in a slowing of the disease in patients with early Alzheimer's disease. The results are statistically significant and are based on a sample of 1,795 people who participated in the study over 18 months. A 27% reduction in cognitive decline was measured by a test assessing global functional and cognitive deficits (CDR-SB - Clinical Dementia Rating-Sum of Boxes scale) in patients who received the drug compared to those who received a placebo.

In June 2021, a related drug, aducanumab, has received accelerated approval by the Food and Drug Administration (FDA) and emerged as the first of a new generation of substances pointing to a clinical benefit associated with amyloid-removal. The results of lecanemab are a reminder that we have entered a new phase in the treatment of Alzheimer's disease. Although still modest, the 27% reduction in cognitive decline measured with this new antibody shows that Alzheimer’s research is on the right track and that the fight against one of the greatest ills of this century can potentially be won.

 The FDA will make its decision on 6 January 2023 under an accelerated approval process, while the European agency will not take a position until March 2023. For the time being, lecanemab is not yet available. The full data will be presented at the Clinical Trials on Alzheimer's Disease (CTAD) conference on 29 November.

Dernière mise à jour : 17/10/2022