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The only approved treatments for Alzheimer’s disease are medications with limited effectiveness and a risk of severe, sometimes deadly, side effects. Researchers found that when the device was aimed at the right spot in the brain, it could slow the development of symptoms, such as memory loss, compared to an inactive treatment. In Alzheimer’s, nerve cells in the brain at some point start to dysfunction, leading to the debilitating symptoms of memory loss. What’s more, during the yearlong TMS trial, participants receiving the experimental treatment showed little decline in their abilities to perform the activities of daily living. Sinaptica’s weekly brain stimulation therapy is intended to strengthen connections in areas of the brain that control memory.
Persons: Giacomo Koch, ” Koch, Koch, Irina Skylar, Scott, , , Lawrence Honig, Honig, Ryan Darby, Darby Organizations: University of Ferrara, Sinaptica, NBC News, TMS, Alzheimer’s Association, Food and Drug Administration, Stanford University’s Center, Memory Disorders, Columbia University Irving Medical Center, Vanderbilt University Medical Center Locations: Madrid, Cambridge , Massachusetts, U.S
It was shown in May and in fuller Phase 3 clinical trial results released at the Alzheimer’s Association International Conference on Monday to delay the disease’s progression. More than 6 million Americans are estimated to have Alzheimer’s disease, with about 1 million estimated to be in the early symptomatic stages where these drugs have shown benefit. Both Leqembi and donanemab work by clearing buildups of a protein in the brain called amyloid, a hallmark of Alzheimer’s. It’s been a hypothesis that treating Alzheimer’s earlier with amyloid-clearing drugs would yield better results; Skovronsky said the donanemab trial bore that out. “We could look at people who had mild cognitive impairment, MCI, which is the earliest stage, versus mild Alzheimer’s versus moderate Alzheimer’s,” Skovronsky explained.
Persons: Leqembi, Eli Lilly’s donanemab, Lilly, “ Donanemab, Jennifer Manly, Kacie, , Dr, Gil Rabinovici, Renaud La Joie, Daniel Skovronsky, , Skovronsky, ” Skovronsky, It’s, Eric Widera, Sharon Brangman, University of Wisconsin’s Dr, Nathaniel Chin, Donanemab, Lilly hasn’t, Lawrence Honig, Honig, White, Sanjay Gupta, Deters, ” Lilly, it’s “, it’s, there’s, Joe Montminy Organizations: CNN, Alzheimer’s Association, Food and Drug Administration, American Medical Association, Columbia University Irving Medical Center, University of California, MCI, SUNY, University of Wisconsin’s, Leqembi, FDA, donanemab, CNN Health, ” Manly Locations: Los Angeles,
CNN —The US Food and Drug Administration is expected to decide on Thursday whether to grant traditional approval to the Alzheimer’s drug Leqembi, the first medicine proven to slow the course of the memory-robbing disease. Leqembi, from drugmakers Eisai and Biogen, received accelerated approval in January based on evidence that it clears amyloid plaque buildups in the brain that are associated with Alzheimer’s disease. But because of an earlier coverage decision by CMS, which provides insurance coverage for many elderly patients with Alzheimer’s through Medicare, the drug hasn’t been widely used. People with more advanced forms of the disease may not benefit from the drug, he said, and may face increased safety risks. Broad Medicare coverage of Leqembi and similar types of medications to slow the progression of Alzheimer’s disease would probably have a big impact on the program’s spending.
Persons: drugmakers, hasn’t, , ’ ”, Joe Montminy, Lawrence Honig, “ It’s, , Honig, it’s, Leqembi, ” Honig, Georges Naasan, Sue Rottura, ” Drugmaker Eisai, “ You’re, Ivan Cheung, Eisai, ” Montminy, Dr, Sanjay Gupta Organizations: CNN, Food and Drug Administration, Medicare, Services, CMS, Columbia University Irving Medical Center, Alzheimer’s, Behavioral, CNN Health, Kaiser Family Foundation Locations: Mount, Florida
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