New Delhi: Cardiologists are advocating for additional research on the drug Lecanemab that can add to limited safety data, currently used for decision-making before initiation treatment of Alzheimer’s disease, according to a viewpoint article published in the Journal of American Medical Association (JAMA).
Initially granted an “accelerated approval” in January 2023, Lecanemab received a full approval from the US food and Drug Administration (FDA) for the treatment of mild cognitive impairment (MCI) or early dementia due to Alzheimer’s disease on July 6 last year.
MCI, an early stage of memory loss and characterised by loss confidence in executing daily activities, can prevail for a few years before advancing to early Alzheimer’s disease: a progressive neurodegenerative disease that destroys memory and eventually the ability to carry out the simplest everyday tasks.
Lecanemab is an anti-amyloid monoclonal antibody medication that targets the deposits or plaques of amyloid beta protein in the brain, typically associated with Alzheimer’s disease.
A study published in The New England Journal of Medicine in January 2023, showed the drugs to slow down the progression of disability by 27 percent over 18 months of drug being administered. Close to 1800 participants were enrolled – 898 were assigned to recieve Lecanemab and 897 to recieved placebo
However in the latest article the researchers has been pointed to major safety concerns from using the drug arising out of bleeding in the brain or cerebral macro hemorrhage. It is one of a range of amyloid related imaging abnormalities (ARIA), which refers to the abnormalities seen in imaging of the brains of Alzheimer’s disease patients.
While mostly asymptomatic and rare the ARIA cases of cerebral macro haemorrhage are “troubling”, because of it’s potential for death and disability , said the researchers from Harvard Medical School and Boston Medical Centre, USA in the study.
“The risk are higher in patients taking anticoagulants (blood thinner)” said the author Darae Ko, a cardiologist and a member the faculty of medicine at Harvard Medical School.
In the JAMA article the autho noted that in approving the Lecanemab , the FDA did not advise regarding the risk of concurrent anti coagulation therapy and the person with cerebral amyloid angiopathy ( amyloid deposits on blood vessels of brain) and those currently prescribed anticoagulants were recommended against being candidates of Lecanemab due to the bleeding outweighs the potential benifits.
Author suggest that in patients treated with anti amyloid medications, it would be particularly challenging to make a critical clinical discussion in patients with three common acute conditions : strokes, heart attacks and blood vessels blockage, owing to limited safety data on Lecanemab which they describe as “an important advance in the treatment of Alzheimer’s disease”.
