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The US Food and Drug Administration on Friday approved a highly anticipated new drug designed to slow cognitive decline in patients in mild and early stages of Alzheimer's disease. The FDA approval of the drug, Leqembi, also known as lecanemab, comes just days after the regulatory agency was harshly criticized in a congressional report for its green-lighting of another Alzheimer's drug, Aduhelm. And it was granted despite trial results showing the monoclonal antibody treatment carries risks of brain swelling and bleeding.

Both drugs were approved through an accelerated process that allows the FDA to fast-track approval of drugs for serious conditions where there is an unmet medical need. Leqembi and Aduhelm, which were jointly developed by Japan's Eisai and Biogen of the United States, "represent an important advancement in the ongoing fight to effectively treat Alzheimer's disease," the FDA said in a statement. "Alzheimer's disease immeasurably incapacitates the lives of those who suffer from it and has devastating effects on their loved ones," Billy Dunn of the FDA's Center for Drug Evaluation and Research said in a statement. Leqembi, Dunn said, is "the latest therapy to target and affect the underlying disease process of Alzheimer's, instead of only treating the symptoms of the disease."

Approximately 6.5 million Americans suffer from Alzheimer's, which is characterized by memory loss and declining mental acuity. Preliminary data from a trial of Leqembi was released in September and found it slowed cognitive decline in Alzheimer's patients by 27 percent. The phase three trial involved nearly 1,800 people, divided between those given the drug and given a placebo, and ran over 18 months. The complete trial data, published in the New England Journal of Medicine, raised concern about the incidence of "adverse effects" including brain bleeds and swelling. The results showed that 17.3 percent of patients administered the drug experienced brain bleeds, compared with nine percent of those receiving a placebo. And 12.6 percent of those taking the drug experienced brain swelling, compared with just 1.7 percent of those in the placebo group. (TheJP)

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Scientists said Monday they had developed a way of predicting if patients will develop Alzheimer's disease by analysing their blood, in what experts hailed as a potential "gamechanger" in the fight against the debilitating condition. Around 50 million people live with Alzheimer's, a degenerative brain disease that accounts for more than half of global dementia cases. While its precise mechanism is not fully understood, Alzheimer's appears to result from the accumulation of proteins in the brain that are thought to lead to the death of neurons. Some of these proteins are traceable in the blood of patients and tests based on their concentrations can be used to diagnose the disease. Scientists in Sweden and Britain now believe blood tests can be used to predict Alzheimer's years before the onset of symptoms. Writing in the journal Nature Aging, they described how they developed and validated models of individual risk based on the levels of two key proteins in blood samples taken from more than 550 patients with minor cognitive impairments. The model based off of these two proteins had an 88 percent success rate in predicting the onset of Alzheimer's in the same patients over the course of four years.

They said that while further research was needed, their prediction method could have significant impact on Alzheimer's cases, given that "plasma biomarkers" from blood tests are "promising due to their high accessibility and low cost". Richard Oakley, head of research at the Alzheimer's Society, said the main struggle in battling the disease was diagnosing cases early enough to intervene with experimental treatments.

"If these blood biomarkers can predict Alzheimer's in larger, more diverse groups, we could see a revolution in how we test new dementia drugs," he said. Musaid Husain, professor of neurology at the University of Oxford, described Monday's research as a "potential gamechanger". "For the first time, we have a blood test that can predict well the risk of subsequent development of Alzheimer's disease in people who have mild cognitive symptoms," said Husain, who was not involved in the study. "We need further validation (of the results) but in the context of other recent findings this could be a transformative step to earlier diagnosis, as well as testing new treatments at earlier stages of the disease." (TheJP)