Plaques of amyloid protein build up in the brains of Alzheimer’s patients
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A drug called donanemab has been shown to slow cognitive decline in people with early Alzheimer’s disease by 35%. However, there have been mixed reactions to the magnitude of the impact this gradual decline will have on the lives of Alzheimer’s patients, with some concerned about the risk of severe brain swelling and bleeding.
Donanemab is an antibody therapeutic drug developed by the US pharmaceutical company Lilly. It binds to clumps of proteins called amyloid plaques that build up in the brains of people with Alzheimer’s disease. This binding activates an immune response to wipe them out.
The drug will target approximately 1,200 people aged 60 to 85 with early Alzheimer’s disease (defined as mild cognitive impairment and dementia due to the condition) in the United States, Canada, United Kingdom, Australia, Japan and Europe. was evaluated in a clinical trial. Participants received intravenous injections of donanemab or placebo every two weeks for 18 months.
At the beginning and end of the trial, participants were assessed on their ability to discuss current events, manage finances, and perform other daily tasks, as well as their cognitive abilities.
Lilly released a summary of results on May 3, showing that the group taking donanemab experienced a 35% slower decline in overall scores than the group taking placebo.
Bruce Brew, University of New South Wales, Australia, said: “Although the full results have not yet been published, the published data show that it significantly slows the progression of Alzheimer’s disease.”
Matthew Schrag of Vanderbilt University in Tennessee said a 35% reduction is a statistically strong effect, but may not be clinically relevant. “It doesn’t bring back people’s memories,” he said. murmured.
In a statement, Alzheimer’s Research UK’s Susan Kohlhaas said it had “moderate therapeutic benefit” but was “on the cutting edge” of new treatments for the condition.
Donanemab has safety concerns, with brain swelling occurring in 24% of people taking the drug. This side effect was not reported in the placebo group. In the donanemab group, 31% had a cerebral hemorrhage compared to 13% in the placebo group.In most cases these resolved with adequate management, but three participants died.
“Before marketing and using donanemab, there is a risk of serious side effects that need to be thoroughly scrutinized,” says Koolhaas.
In November, it was reported that another experimental amyloid-scavenging antibody treatment called lecanemab, developed by Japanese company Eisai, slowed cognitive decline in patients with early Alzheimer’s disease by 27% for more than 18 months. It has been associated with brain swelling and bleeding in some people and is awaiting regulatory approval.
An amyloid-clearing antibody treatment for Alzheimer’s disease is already on the market, aducanumab, which was approved by the US Food and Drug Administration (FDA) in 2021. However, it has only been shown to clear amyloid from the brain, not improve it. Symptoms of Alzheimer’s.
Lilly said it will submit to the FDA for regulatory approval of donanemab during the current fiscal quarter.
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