Alzheimer's drug under study at University of Ky. and other sites has shown it is 'the first crack in the iceberg,' UK researcher says

By Al Cross
Kentucky Health News

A partially approved drug for Alzheimer's disease that slowed memory decline and loss of functional ability in a study is “the first crack in the iceberg for us,” says a Kentucky researcher involved in the study.

Dr. Greg Jicha of the University of Kentucky, one of about 100 study sites, told reporters last week that he expects more progress.  “Hopefully the day will come when Alzheimer’s will be no more,” he said. “This is fundamentally the start of that process.”

Dr. Greg Jicha (UK photo by Mark Cornelison)

Jicha said in a UK news release, “For the first time, having a medication that we understand can fundamentally change the disease process is the first step and it’s a giant step,” said Jicha. “It tells us and teaches us all that we are on the path to the eventual cure for Alzheimer’s that we’re all looking for.”

On Jan. 6, the Food and Drug Administration approved the drug lecanemab for Alzheimer's patients who have mild cognitive impairment or are in the mild dementia stage of the disease.

That's the population being studied in clinical trials, which have found that the drug slowed memory decline by 27 percent and the loss of functional ability by 40%. While the drug does not cure the disease, it "could mean two to two and a half more years of functional life," Jicha told reporters. "That is meaningful; an extension of quality of life."

Jicha said several medicines are available for Alzheimer's, but they treat only symptoms of the disease, and the last one was approved 20 years ago.

The drug removes from the brain the amyloid proteins that are believed to cause Alzheimer's. The plaques can show up in people with very mild memory problems, Jicha said; one of three Americans over age 65 have them.

The study continues, to see if the drug can be used to remove plaques earlier and delay onset of teh disease, Jicha said. "Hopefully we’ll have that answer in the next five to seven years."

UK is still recriting participants for the study. It uses a simple blood test for the protein or likelihood of buildup. If there is a high likelihood, imaging of the brain can see the plaques may be performed. If they are found, the person gets into the study. But only half of them get the drug; the others get a placebo, which is standard for clinical trials. They could get the drug if the study is successful, Jicha said.

To learn more about the study, call 1-800-AHEAD-70 or to find a trial site location enrolling near you, visit www.AHEADstudy.org.

The next step in the study could lead to approval for payments by Medicare and private insurance. The drug's manufacturer, the Japanese firm Esai, says it would like to charge $26,000 a year for the treatment, which requires an infusion every two weeks. Jicha said the Institute for Clinical and Economic Review, a nonprofit organization that does clinical and cost-effectiveness analyses of treatments, has suggested an annual price of $21,000.