They also beg the question about still-earlier intervention, adds Dr. But we’ll need more studies to determine if that’s true.” The data appear encouraging that the longer the treatment period, the better the effect. “These results could also indicate a starting point for bigger effects. “Would I like the numbers to be higher? Of course, but I don’t think this is a small effect,” says Dr. Participants also showed a 26% slowing of decline in a key secondary measure of cognitive function and a 37% slowing of decline in a measure of daily living compared to the placebo group. Study participants who received the treatment had a significant reduction in amyloid burden in imaging tests, usually reaching normal levels by the end of the trial. “The antibody treatment selectively targets the forms of amyloid protein that are thought to be the most toxic to brain cells,” says Dr. In a trial that involved 1,795 participants with early-stage, symptomatic Alzheimer’s, lecanemab slowed clinical decline by 27% after 18 months of treatment compared with those who received a placebo. How effective is lecanemab for Alzheimer’s disease? van Dyck, who answered three questions about the new treatment. This is the first time in two decades that the FDA has granted full approval to a drug for Alzheimer’s, but there is also a “black box” warning on the medication-the agency’s strongest caution-because of safety concerns. “It’s very exciting because this is the first treatment in our history that shows an unequivocal slowing of decline in Alzheimer’s disease,” says Dr. Lecanemab works by removing a sticky protein from the brain that is believed to cause Alzheimer’s disease to advance. Sold under the brand name Leqembi™ and made by Eisai in partnership with Biogen Inc., the drug is delivered by an intravenous infusion every two weeks. van Dyck is also a paid consultant for the pharmaceutical company Eisai, which funded the trials.) 5 issue of The New England Journal of Medicine that shared results of a Phase III clinical trial of lecanemab. ![]() Christopher van Dyck, MD, director of Yale’s Alzheimer’s Disease Research Unit, was the lead author of a study published in the Jan. ![]() In January, the FDA gave the medication an accelerated approval based on amyloid plaque clearance. It can also cause a range of behavioral changes. Over time, the disease leads to a gradual loss of cognitive functions, including the ability to remember, reason, use language, and recognize familiar places. The Food and Drug Administration (FDA) recently granted full approval to a new Alzheimer’s treatment called lecanemab, which has been shown to moderately slow cognitive and functional decline in early-stage cases of the disease.Īlzheimer’s disease is a progressive disorder that damages and destroys nerve cells in the brain.
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