Cleveland Clinic and University Hospitals are now treating patients with Lecanemab, a drug to treat Alzheimer's disease formally approved last July by the Food and Drug Administration.
The medication has been shown to slow patients’ rate of cognitive decline 27%, by reducing certain plaques that form in the brain. Lecanemab is administered every two weeks through IV infusion, with each session lasting about one hour. Infusions occur for one year for a total of 26 treatments.
Cleveland Clinic started treating patients with Lecanemab last fall and is currently treating a dozen patients. University Hospitals began treating its first patient earlier this month and is treating six patients overall.
Both Dr. James Leverenz, director of Clinic's Cleveland Lou Ruvo Center for Brain Health and the Cleveland Alzheimer's Disease Research Center, and Dr. Charles J. Duffy, director of the Brain Health & Memory Center in the UH Neurological Institute, are lauding the drug.
"This is really the first drug that's been approved that we know seems to really attack the disease itself," Leverenz said. "We like to call it disease-modifying."
Duffy added his patients are excited about the potential of this new treatment.
"This is the first treatment that has ever been available that really changes the disease," he said. "To be able to have a positive impact on people's lives is a tremendous opportunity. Someone like me, who's been in this field for a long time, it's revolutionary. Now we have something to offer that really changes what's going to happen, and that's very exciting."
Amy Boehm, associate director of health systems for the Alzheimer's Association Cleveland Area Chapter, called the hospitals' use of the treatment welcome news for Alzheimer's patients.
"We are excited to have more and more health systems come on board and offer this treatment to those that might qualify for it," she said.
The drug makes a tremendous difference for Alzheimer's patients and their families, she said.
"Right now we're looking at approximately five, six months slowing the progression," she said. "And you might think that's not a lot of time. But for someone facing this disease and especially someone in more of an earlier onset of the disease, this can buy them more time driving. It can buy them more time working in a career they love, more time with their family and more time planning for their future. That is what we're so excited about, that this is offering more time."
The medication is covered by Medicare and Medicaid as well as some insurers, Leverenz said. Private insurers are also covering the treatment once doctors can show a patient has indicators of Alzheimer's and is showing cognitive effects from the disease.
He said approval "takes a little while, but I think we're up to over 30 people now who've been approved and we're just starting to get them in for therapy."
Public Citizen, a nonprofit consumer advocacy organization, argued the drug should be pulled from the market due to its potential side effects. Their stance was partially in response to Biogen's Jan. 31 announcement that it was pulling its other Alzheimer's drug, Aducanumab, from the U.S. market.
"Of greater concern is Lecanemab (Leqembi), Biogen’s second drug for Alzheimer’s disease, and another FDA failure," the group wrote in a Feb. 1 news release. The group cited a black box warning that the drug can cause brain swelling and bleeding risks.
Both Leverenz and Duffy said they take precautions to prevent such side effects by assessing the likelihood of their onset in each patient and make the patient and their families aware of the risks before starting the treatment.
Once treatment does begin, doctors closely monitor for indications of side effects, the said.
"We keep our eyes open, particularly for what we call microhemorrhages, small hemorrhages that we can see again, that may be without symptoms," Leverenz said.
Leverenz added such potential side effects are much more likely in the first few months of treatment, so his team of doctors monitor more frequently at the outset of treatment.
"This is a whole new world for people suffering from Alzheimer's disease."Dr. Charles J. Duffy, director, Brain Health & Memory Center at University Hospitals Neurological Institute
Duffy said UH also informs patients and their families of the risks and benefits of the drug and takes steps to ensure the drug is right for them, including whether they're more likely to develop complications. They make sure the patient is in the earlier stages of the disease and that Alzheimer's is the cause of their cognitive decline, then assess whether they'd be susceptible to the side effects by studying their medical history and other drugs they're taking. They also do genetic studies using blood tests to determine risk profiles.
"All of the medical people, of course, are focused on making sure that this patient is going to be appropriate for treatment with these medicines and understand what it's about," Duffy said.
Leverenz added time is of the essence for these patients.
"For some individuals and for some families, they don't know if they have the time to wait for another drug, [and] they really want to give it a try," he said.
The Alzheimer's Association's Boehm agreed patients need to weigh the benefits and risks of the medication.
"I think what families are discussing is the risk, which could be potential brain bleeds, but weighing that against, does this allow my family member to have more time doing the things that they love to do and have a good quality of life?" Boehm said.
Experts are now considering whether they can administer the drug by injection under the skin instead of infusion using an IV. Doing so would make the treatment more convenient for the patient, Leverenz said.
"If that comes to fruition, you could see people coming in initially for the first half-dozen to 10 treatments and then maybe getting the treatment at home, which would be really nice," he explained.
But, for now, Duffy said just having the treatment is making a significant difference in patients' lives.
"This is a whole new world for people suffering from Alzheimer's disease," he said.
According to the Cleveland chapter of the Alzheimer's Association, 6 million Americans are living with Alzheimer’s, including 220,000 Ohioans. The number of Ohioans living with Alzheimer's is expected to increase to 250,000 by 2025. One in three seniors dies with dementia — more than breast and prostate cancer combined, the group said in a recent release.
