The USFDA recently approved lecanemab, an IgG1 monoclonal antibody, for the treatment of patients with mild dementia stage of Alzheimer’s or mild cognitive impairments, through an accelerated approval pathway on the basis of a phase 3 clinical trial. based on the results of a phase 3 randomized controlled clinical trial. Drug details This approval is based on findings of a double-blind, placebo-controlled, parallel-group, dose-finding study. The details of the study are as follows: Lecanemab is useful in reducing amyloid plaques in the brain, a useful marker of Alzheimer’s disease.
However, it has some adverse effects, including amyloid-related imaging abnormalities, infusion-related reactions, and headaches. More trials are needed to validate the safety and efficacy of lecanemab in the earlier and later stages of Alzheimer’s disease. ##Sources## USFDA Van Dyck CH, Swanson CJ, Aisen…