UK's Sanders-Brown center is among first sites to test a promising new drug to slow Alzheimer's, and is looking for study participants-HEALTHYLIVE

Mike Brown of Morehead is one of the participants in the current Alzheimer's disease study at UK.

Story and photos by Hillary Smith

University of Kentucky

The University of Kentucky is one site for the first-ever clinical trial to test an investigational antibody for people who have no cognitive symptoms of Alzheimer’s disease but may have “preclinical” AD. 

In September, drug maker Eisai announced positive results from a third-phase study evaluating lecanemab, an investigational antibody for treatment of mild cognitive impairment due to AD and mild AD dementia (collectively known as early AD) with confirmed presence of amyloids, abnormal proteins that form plaques that disrupt brain function.

Just last week, at the International Clinical Trials on Alzheimer’s Disease meeting in San Francisco, Eisai presented results that demonstrate an almost complete removal of amyloid plaques from the brain of those with early Alzheimer’s, an effect that was associated with a 27 percent slowing of mental decline. The study also showed that lecanemab leads to a 31% lower risk of the next stage of disease.

The next study will test whether those effects in the clinically symptomatic population are similar in people whose lab tests indicate they have amyloids in the brain, or preclinical AD. That excites Dr. Greg Jicha, director of clinical trials at UK’s Sanders-Brown Center on Aging. 

Dr. Greg Jicha (UK photo by Mark Cornelison)

“When doctors, researchers and scientists from across the globe, including myself, saw the data for the first time, the excitement was contagious,” Jicha said. “We all realized that for the first time ever in the history of drug development for Alzheimer’s disease, we have broken down the barriers that will one day move us to a cure. Our excitement was propelled by the knowledge that we can succeed eventually in eradicating Alzheimer’s and that even better medicines are on their way.”

Jicha says UK has been working with patients to provide access to lecanemab for over a decade, and has successfully removed amyloids from dozens of brains.

“We think we are taking this one over the finish line,” Jicha said. “I see hundreds of patients each year that are shocked that they have received the death sentence of Alzheimer’s disease. As of now, there are no cures for this fatal disease that is the sixth-leading cause of death in the U.S. We need to know if we can screen and stop this disease before it destroys the lives of those we love or takes our own lives.”

Looking for a path forward as they age as well as a way to help others are big reasons why many get involved in research at UK.

“I’m retired and just want to help people anyway I can,” said Mike Brown, who participates in research at Sanders-Brown alongside his friend Jim Jackson. The duo travels from Morehead every two weeks along with their wivefor their visit.

“We make a fun little day out of it,” said Sharon Jackson, Jim's wife. “We always try to eat somewhere different.”

Jim Jackson is a retired pediatrician. With his medical background, “I knew I wanted to be part of it,” he said “This is the way science works.”

Dr. Jim Jackson of Morehead is another participant in the study.

Jackson and Brown have been participating for several months in the Eisai study, starting the medication in May 2020. That part of the study, as in most clinical trials, had a placebo group. They are still blinded for that part of the study, so they do not know yet if they had been receiving lecanemab. “You just have to be optimistic and know you are helping others,” Jackson said.

Both of them qualified for, and are now in, the open-label extension of the study, which began in November 2021. This allows them to confidently get lecanemab for several months. Hearing the recent news about the early results for this drug provided an extra dose of enthusiasm for the couples.

“I am just so thankful Jim is part of this, because if it prolongs his memory any amount, it is very much worth it,” said Sharon. “Dr. Jicha and the team here at UK are so great and informative. We always have a comfortable experience here. We are so blessed to have a place like this right here in Kentucky. More people should consider getting involved and using the resources offered at Sanders-Brown.”

Jicha says they are proud that Sanders-Brown, founded by Col. Harland Sanders and John Y. Brown Jr. of Kentucky Fried Chicken fame, is at the forefront of these discoveries.

“You might think such possibilities are limited to the rich and famous; you might think such possibilities are only available in Washington, D.C., New York, Chicago or L.A.," Jicha said. "But you should know that the UK Sanders-Brown Center on Aging is at the forefront of these discoveries, bringing them here to Kentucky long before they may be available to others in the United States.”

The study is the first AD trial to recruit people as young as 55 who are at risk of developing symptoms of AD as they get older.  

Researchers want to make sure the opportunity is available to a wide range of the population. “We especially want to reach out to those that have experienced health care discrimination,” said Jicha. “If you live in a rural area or are a person of color, you should know that we value you as much as we do everyone else. An effort this important needs to be available to everyone.”

Jicha says researchers believe the future of healthy brain aging is within their grasp. “For many, it may be too late for lecanemab to help, but we are not giving up on them either. We have over a dozen active experimental medicine trials for anyone at risk, currently experiencing memory loss, or even those with more advanced stages of Alzheimer’s disease or other forms of dementia. If you are looking to do more for yourself or a loved one, please reach out to us now.”

The study is funded by the National Institutes of Health and Eisai, a U.S. subsidiary of the Tokyo -based firm Eisai Co. Ltd. It seeks 1,165 participants from North America and has more than 100 study locations, including Japan, Singapore, Australia and Europe.

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. Learn more about enrolling in aging studies at Sanders-Brown here.

from KENTUCKY HEALTH NEWS https://ift.tt/LqjZcWs

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