An investigational new Alzheimer’s drug has significantly slowed disease-related cognitive decline by about 35 percent and the ability to carry out daily activities by 40 percent. The results of an experimental study were announced by the pharmaceutical company Eli Lilly, which has been engaged in research against this disease for years and is ready to request authorization soon. In a placebo-controlled study on almost 1,182 people with early forms of Alzheimer’s, donanemab slowed the progression of symptoms by 35% over an 18-month period: this effect was measured by comparing the ability to perform daily activities such as managing money, driving, engaging in hobbies and having conversations about current events. Side effects included microhemorrhages.
In Alzheimer’s disease, two key proteins, tau and amyloid beta, build up in tangles and plaques, collectively known as clumps, which cause brain cells to die. donanemab targets amyloid-beta, as does lecanemab, another drug developed by Biogen and Eisai, which showed a decline of 27% and was approved by the United States last January.
Lilly said it will quickly submit the results of the new study to the U.S. Food and Drug Administration and other global regulators.
“We are pleased that donanemab has delivered positive clinical results with compelling statistical significance,” Lilly chief scientist and chief physician Daniel Skovronsky said in a statement. “This is the first Phase 3 study of any investigational Alzheimer’s drug to provide a 35% slowing of clinical and functional decline,” he adds. These results, for Mark Mintun, vice president of the Eli Lilly research group, “suggest that people in the early stage of the disease may be the most responsive to amyloid-targeted therapies”.
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