The Cleveland Clinic and University Hospitals, along with researchers at The Ohio State University, are part of the first study to determine whether newly approved Alzheimer's drug lecanemab not only can slow progression of the disease, but actually prevent it.
Institutions including Cleveland Clinic participated in clinical studies of the drug, also known by the brand name Leqembi, starting in 2020. According to the Clinic's Lou Ruvo Center for Brain Health, lecanemab is the first new Alzheimer's drug with full approval in 20 years and one of the first therapies that can slow progression of Alzheimer’s disease, not just treat its symptoms.
The drug was formally approved by the U.S. Food and Drug Administration July 6 for the treatment of the disease. According to the FDA, the drug does come with possible side effects, including swelling or bleeding in the brain.
The clinical trial found the drug led to a 27% slowdown of the disease's progression among participants by reducing amyloid plaque that form in the brain, leading to memory loss associated with Alzheimer's. According to the study, memory loss is one of the first indicators of Alzheimer's, followed by deteriorating mental functions and eventually death.
The Alzheimer's Association projects 250,000 Ohioans will have Alzheimer's by 2025, a 13% increase from its 2020 estimate. According to the Centers for Disease Control and Prevention, Alzheimer's is the seventh leading cause of death in Ohio, which recorded a 34.2% Alzheimer's mortality rate in 2021 with 4,947 deaths in total that year.
The study, known as the AHEAD Study, is being conducted by the National Institutes of Health's Alzheimer’s Clinical Trial Consortium, a network of leading academic Alzheimer’s research centers, at 100 sites worldwide, including 75 in the U.S. and Canada. The four-year-long study focuses on approximately 1,400 people ages 55 to 80 years old who do not yet have symptoms of Alzheimer's, but have a family history of the disease or otherwise have a risk of developing it through gene testing or biomarkers.
Bill Kerr, a participant in the study, said he joined the study because his mother and aunt both developed Alzheimer's in 2008.
"I just thought it would be a good idea to get involved," he said. "It's because I was in a high risk group."
Kerr said he's been involved in the study since it started in 2020 and says the study is incredibly important given the difficulties those diagnosed with Alzheimer's and their families and caregivers face.
"Having experienced it myself from my mother and her sister, I know what a difficult thing it can be, obviously, for them and for the people that are caring for them," he said. "It affects millions, millions."
Kerr said he's happy to be a part of the study.
"It's an extremely serious problem," he said. "So anything that can be done to help treat this and deal with Alzheimer's, maybe minimize the effects of illness. It's worth the effort on my part and other people's parts."
Dr. Rajeet Shrestha, University Hospital's principal investigator, and Dr. Babak Tousi, the study's principal investigator at the Cleveland Clinic, agreed this research, when combined with breakthroughs in delaying symptoms of Alzheimer's, has the potential to change millions of lives for the better.
"Alzheimer's is something that touches everybody in one way or another, whether it's through suffering of, you know, patients who have or diagnosed or who, you know, or family members who, you know, deal with such fortitude, they ask different aspects of caregiving, seeing their the family member of a loved one kind of go through the stages of this illness," Shrestha said. "I am very excited that with with developments like these that we can offer more for our patients."
Tousi added, "I think that's going to make a big change in people's life if we can change the onset of symptoms to much later down the road."
The study itself involves infusions of lecanemab and blood tests, biomarkers and PET scans to determine amyloid plaque levels in the brain and whether these decline over time. This is combined with a series of memory tests to determine whether there is any neurological decline.
While the study has been ongoing since 2020, it is only approximately halfway towards the goal of 1,400 participants, Shrestha and Tousi said. The problem, Susie Sami, University Hospital's study coordinator, said is due, in part, to the difficulty in getting participants, especially from underrepresented groups who are supposed to represent 30% of those in the study.
She said the problem is two-fold, with both a lack of trust and the large commitment the study represents.
Sami added, while this has been challenging, ensuring a representative population in the study is essential.
"It's very important if something is to become approved, that it's approved and then works on the whole population," she said. "Not a certain group. ... "So it's very important for underrepresented groups to participate in research because we want to make sure that the results are generalizable to everybody."
Shrestha agreed this is necessary, especially given higher Alzheimer's rates among minority groups.
"It's a very important issue in clinical trials all over, but it's more important in Alzheimer's research because we know that ... African American, Hispanic folks have almost twice the rate of dementia as opposed to their white counterparts. But when you look at clinical trial population, they're very underrepresented," he said.
Sami said the solution to this problem is outreach and explanation of the benefits involved.
"The most important thing to do is to establish trust, like people are not going to come to us if they don't realize that we we think that they're important," Sami said. "And it's not just a data point for us. It's a person and we're going to take care of that person while they're participating in a clinical trial so that some of our efforts have been in going out and doing community outreach."
That community outreach includes going to health fairs such as MetroHealth's Multicultural Women’s Health & Empowerment Expo and the Cleveland Clinic's Celebrate Sisterhood program, she said, adding there's another health fair they're attending on Martin Luther King day in 2024. Researchers are also working with the Alzheimer's Association and a task force of African American fraternities and sororities, known as the Divine Nine, to engage the community, Sami said.
Beyond the obvious advantages to delaying, if not preventing, the onset of Alzheimer's, there's also the lesser known benefit of greater access to healthcare that's a part of participating in the study.
Sami said, "you talk about access to care in the health care industry. You know, it's very limited. But I think participating in research is an access to resources. So they would be the resources would be available to them once they start participating."
The study is expected to be completed in 2027.
