FDA approves Alzheimer’s disease treatment under clinical trial at University of Kentucky
First medicine ever to change the disease in the brain can extend quality of life, says UK’s Dr. Greg Jicha
Jim Jackson of Morehead participates in a clinical trial at the University of Kentucky for a treatment for Alzheimer’s disease that has received Food and Drug Administration approval. (Photo provided)
A key antibody treatment in the fight against Alzheimer’s disease, which the University of Kentucky has been studying, just got a full green light from the U.S. Food and Drug Administration.
The approval, which came out Thursday afternoon, means that many Kentuckians with mild cognitive impairment may enjoy an extension of their quality of life.
Dr. Greg Jicha, the director of clinical trials at UK’s Sanders-Brown Center on Aging, told reporters Friday that while the approval is exciting, this is not a cure for Alzheimer’s.
“We’re not there yet,” he said. “But this is the first medicine ever that actually changes the disease in the brain, removes a component of the disease and can extend quality of life for patients who are developing and who are in the early stages of Alzheimer’s disease.”
What is Lecanemab?
Lecanemab (brand name Leqembi) is an antibody that targets — and in some cases, may remove — amyloid plaques from the brain, slowing cognitive decline. Japanese pharmaceutical company Eisai and its U.S. partner Biogen developed the drug.
Amyloid plaques are materials in the brain outside of nerve cells. In an Alzheimer’s brain they can keep cells from properly functioning.
The treatment does come with the FDA’s strongest safety warning because of a risk of potentially dangerous brain swelling.
“If we remove the amyloid too rapidly,” said Jicha, “it can cause swelling in the brain or bleeding into the brain. We call these amyloid-related imaging abnormalities.”
Patients with mild Alzheimer’s or mild cognitive impairment may get six months back from the 18-month treatment, UK said.
The full approval “is the first verification that a drug targeting the underlying disease process of Alzheimer’s disease,” Teresa Buracchio, acting director of the Office of Neuroscience in the FDA’s Center for Drug Evaluation and Research, said in a statement.
It “has shown clinical benefit in this devastating disease,” Buracchio said, and “it is a safe and effective treatment.”
The most common form of dementia, according to the Centers for Disease Control and Prevention, Alzheimer’s is characterized by memory loss and affects millions nationwide. In 2021, 1,632 Kentuckians died from it, according to the CDC.
Morehead couple Jim and Sharon Jackson, who the Lantern featured in February, celebrated the approval.
Jim is a study participant who’s been receiving Lecanemab through a clinical trial at UK. He was diagnosed with Alzheimer’s in 2020.
“I felt that it was really a good opportunity to be part of something that can improve life for many, many people,” said Jim, a retired pediatrician.
Jim didn’t suffer any notable side effects from the treatment, wife Sharon said Friday.
“Jim had a little bit of memory issues” at the start of his diagnosis, Sharon said. “And I can pleasantly say that it has not progressed very much.”
“This medication, from what I had understood about Alzheimer’s, seems to be holding him pretty steady,” she said.
Who is eligible for this treatment?
Not everyone is eligible for the treatment, which involves an hour-long IV every two weeks.
“This medicine is only for those with mild memory problems, what we call mild cognitive impairment,” Jicha said. “Once the disease progresses to a more moderate or severe stage, we no longer understand if there could be benefit or not.”
People at risk of developing Alzheimer’s are also not eligible. Trials still need to determine the benefit of treating them with this antibody.
Those who are experiencing the early stages of memory problems can talk to their doctor about Lecanemab, Jicha said. But once the patient enters the moderate stages of the disease, it’s no longer an appropriate treatment route.
Will my insurance cover Lecanemab?
Medicare is expected to cover Lecaneman, Jicha said.
“Typically, if Medicare covers it, Medicaid covers it, and almost every third party insurance will cover it,” he said.
Folks may still have to cover a co-pay, though.
“I really think it behooves all of us to ensure that this medicine is accessible to everybody,” Jicha said. “No matter what their socioeconomic status, no matter what their geographical limitations are. Everyone who has early Alzheimer’s disease deserves the opportunity as long as the medicine is going to be safe for them.”
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