The association between the accumulation of amyloid plaques in the brain and the development of Alzheimer’s Disease (AD) has been known for decades and the emphasis on finding a cure has largely been based on targeting those plaques. The FDA has just approved an anti-amyloid medication called donanemab (brand name Kisunla) which is a once per month injection for intravenous infusion in patients with early symptomatic Alzheimer’s disease (AD), mild cognitive impairment (MCI) or mild dementia stage of disease with confirmed amyloid pathology.
It is the only therapy with evidence that supports stopping the treatment once the amyloid plaques have been removed. Currently that is being assessed by the PET imaging with amyloid contrast. In the clinical trial, some were able to stop treatments as early as 6 months after starting it, while the majority were deemed amyloid plaque-free by 18 months. The beauty in this is breakthrough is that treatment is finite, resulting in better quality of life and lower healthcare costs.
The data on which the FDA based its decision showed that donanemab not only significantly reduced the amount of brain amyloid plaques, but it also significantly slowed cognitive and functional decline compared with placebo in early symptomatic AD.
Like other anti-amyloid agents, donanemab carries the risk for amyloid- related imaging abnormalities (ARIAs). But the FDA unanimously ruled that the benefits outweighed the risks and that the risks were considered “acceptable and manageable”. Because there is now a treatment that will potentially stop the disease process and reverse damage, it is more important than ever that the disease be detected early.
BeCare Neuro Link can help by screening for the cognitive, motor and other signs of early AD by its remote mobile app. The patients can choose to use the app to decide if they need to pursue further evaluation and physicians can rely on the data on when to start testing for this devastating disease.