Some Alzheimer’s Disease patients now have the option to take medication that has been shown to slow the progression of the disease.

In July, the U.S. Food and Drug Administration (FDA) announced traditional approval of the drug lecanemab (brand name Leqembi) for patients with early-stage Alzheimer’s Disease. It marks the first full approval of an Alzheimer’s drug that can slow its progression, and the beginnings of Medicare covering the drug.

Lecanemab targets a protein found in the brains of Alzheimer’s patients—amyloid plaque, which disrupts cell function. According to studies required by the FDA, lecanemab helps to reduce the amount of that protein and has a functional benefit in patients.

The Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas took part in the clinical trial that the FDA required as a condition for traditional approval. Now, the center is conducting another trial, part of the Ahead Study, to see if the drug can be effective even before Alzheimer’s is diagnosed.

“We know amyloid plaques are one of the first features of Alzheimer’s Disease that occur in the brain itself. And we think, in some sense, there are triggers of a subsequent cascade of injurious reactions that lead to cell death,” says Dr. Charles Bernick, a neurologist leading the Ahead Study at the Ruvo Center. “So the thought is, if you can remove the plaques from the brain, you can interfere with that process and hopefully modify the disease course over time.”

The Ahead Study is an international medical study, funded by the National Institutes of Health, testing the effectiveness of lecanemab in people who do not yet have cognitive symptoms of Alzheimer’s but have amyloid protein in their brain and are at risk for developing Alzheimer’s later in life.

Local trial participant Verna Peterson, 72, has not been diagnosed with Alzheimer’s Disease. But she has a family history and underwent tests that found she’s at higher risk for the disease.

Her experience with Alzheimer’s goes back to her mother. “When my mother was in her mid 70s, she started to get a bit strange,” Peterson explains during an infusion of lecanemab or a placebo. “We noticed she wasn’t the bright and alert woman we’d known.”

Her mother’s diagnosis with Alzheimer’s was a deciding factor for her participating in the trial. “This is for my mother, because she never had the opportunity,” she says.

In the Ahead Study, lecanemab (or the placebo) is administered via IV infusion every two to four weeks, depending on the amount of amyloid found in the patient’s brain. Peterson underwent diagnostic tests to verify the presence of amyloid protein in her brain and whether she had certain risk factors for side effects, before starting the trial.

“I had a little bit of the side effect at the beginning. You know, headaches and what have you. But that kind of went away,” she explains.

Side effects from lecanemab are rare and can include headache and amyloid-related imaging abnormalities (ARIA), which most commonly present as temporary swelling in areas of the brain. ARIA is often not associated with any symptoms but can present symptoms including headache, confusion, dizziness and vision changes. Infrequently, ARIA can lead to serious and life-threatening brain conditions, including seizures and brain hemorrhage.

“With lecanemab, just statistically if you consider everybody, the symptomatic group is only 3% or 4% of people who take the drug. So it isn’t high,” Bernick says. “But if you’re the one who gets it, it’s a concern. So the drug has to be monitored.”

The Ruvo Center currently is working with six participants in the Ahead Study, and is seeking more participants.

Accessing Lecanemab Treatment

Lecanemab cannot stop or reverse Alzheimer’s Disease, and it works only in patients in the early stages of the disease. But considering it’s the first FDA-approved drug shown to slow the progression of the disease, many families are surely asking how they can access the treatment.

According to the University of California San Francisco Memory and Aging Center’s website, the treatment isn’t yet clinically available at any University of California hospitals. The Alzheimer’s Association says manufacturing and nationwide distribution could take some time, and that patients should ask their doctors about availability.

Although lecanemab became available as a treatment in January under accelerated FDA approval, the Centers for Medicare & Medicaid Services (CMS) said it wouldn’t cover Alzheimer’s treatments that are under accelerated approval.

“Leqembi has been on the market since January 2023, when it received accelerated approval from the FDA. However, to this point access has been blocked by Medicare coverage policies,” reads a statement in part from the Alzheimer’s Association.

The FDA’s traditional approval of lecanemab triggered Medicare and Medicaid coverage of the medication, albeit with some conditions. According to the Alzheimer’s Association, Medicare will cover the drug as long as a physician enrolls a patient in a registry run by the Centers for Medicare & Medicaid Services. Medicaid will cover a copay for the medication, which has been priced at $26,500 per year.

Because lecanemab must be administered by IV infusion, physicians need the capability to provide that type of treatment on a regular basis over the course of years.

While rollout has yet to be seen, approval of the medicine marks a major milestone in Alzheimer’s therapeutics, and hopefully will facilitate further studies, Bernick says.

“We’ve gone through a lot of drugs, with essentially no movement in terms of therapeutics for 20 years. And now I think we’re just in a new era of treatments,” he says. “We’re finally seeing a class of medications that can change the disease process, not just symptomatic drugs. It’s a tremendous breakthrough in the field.”

Clinics across the country, including the Ruvo Center are preparing to offer lecanemab treatments, which are done through IV infusion every two weeks, once it’s available.

“Clinical availability for our patients will likely start later this year,” says Elizabeth Smith, a spokeswoman for the Lou Ruvo Center.

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