Wait for Alzheimer's drug ends, but race for access begins

Kanada Yazbek is in a race to access a new Alzheimer's drug while she still has a chance to try to slow her loss of memory and thinking skills.

Lecanemab was approved by the U.S. Food and Drug Administration on Thursday as the first drug to delay the effects of Alzheimer's disease, but only for people in an early phase known as mild cognitive impairment. Yazbek is in that sweet spot, but any decline could make the 49-year-old Ramsey woman ineligible for the drug.

"During this time while we've been waiting, 2,000 people a day would transition from mild [impairment] to becoming ineligible," she said. "So, yeah, timing is huge."

Yazbek and others will have their patience tested, though, because access to the drug could be months away. Full approval was a key step and unlocked federal plans to pay for the drug for elderly and disabled Medicare recipients. But now Minnesota medical providers must scramble to meet its complex diagnostic and monitoring requirements.

Mayo Clinic participated in clinical trials of lecanemab and has been preparing for its availability for months. Yet Mayo doesn't expect to provide the drug until the fall. And because of the monitoring requirements, the Rochester health system will provide it at first only to nearby patients in southeast Minnesota.

"We're going to be conservative in rolling this out early," said Dr. Ronald Petersen, director of Mayo's Alzheimer's Disease Research Center.

Lecanemab, which goes by the brand name Leqembi, slowed cognitive and functional losses by 27% over an 18-month clinical trial. The drug clears out amyloid deposits in the brain that have been associated with Alzheimer's-related dementia, so the first step for patients is imaging scans to confirm that they have those proteins.

Brain bleeds are a potential side effect, so doctors also must rule out patients with a prior history of the problem. They then conduct routine imaging scans to see if bleeding emerges in patients while they receive every-other-week infusions of the drug.

Even if the drug only slows dementia by months, many patients will gladly take it and put up with numerous medical appointments, Petersen said.

"They are still driving, paying their bills, doing their taxes, but they know they are on the road [to further declines]," he said. "They say to me, 'if you can keep me at this stage, it's inconvenient, but I'll be happy.' "

Yazbek recently retired as a real estate agent and owner of a cleaning company that raised money for the Alzheimer's Association. Stress and sleeplessness can exacerbate her cognitive and memory problems; work exacerbated both.

As the seventh person in her family to be diagnosed with Alzheimer's or related forms of dementia, Yazbek said, she has seen what the disease can do to people without any treatment to stop it. She has an appointment next week with a neurologist to discuss the drug, because she wants to maximize her time with her life partner and three grade-school-age stepchildren.

"It's not like a cure, but it will give us time," Yazbek said. "And who knows what things will look like? A year ago, we weren't having these conversations. We were talking about 'What if a drug comes along?' "

Lecanemab is the first in a series of incoming drugs that target amyloids, but researchers are split over whether these proteins are the smoking gun of Alzheimer's. Others are targeting tau tangles that form inside the brain's thinking cells. University of Minnesota researchers are developing a drug that targets an enzyme that causes tau malformation.

In the end, it may take a cocktail of drugs to combat dementia, but for now the goal is to maximize access to the new drug, said Susan Parriott, chief executive of the Alzheimer's Association Minnesota-North Dakota Chapter. Doctors didn't screen for mild cognitive impairment in the past or reveal their suspicions to patients because they couldn't offer treatments. She said that mindset must change.

"We need to make sure that physicians understand the disease, understand how to diagnose it, so that people can be eligible," Parriott said.

Minneapolis-based Allina Health probably won't offer lecanemab for months, but Dr. Ron Tarrel said patients should be getting screened because they can still manage cognitive symptoms through diet, exercise, sleep and brain-stimulating activities.

"All of those things can help with memory and generally make life better," said Tarrel, a neurologist.

Practical questions remain about lecanemab, including whether private insurers will follow Medicare's lead and pay for it. Petersen said the short duration of the clinical trials limits knowledge about the drug's effectiveness. Medicare is requiring a registry of patients receiving the drug in order to learn about the length of its benefits and any side effects too rare to detect in initial trials.

Lecanemab also might work against more advanced forms of dementia, or even prevent the disease in people who have amyloid deposits in their brains but no symptoms. Mayo is part of a national trial that is evaluating whether the drug offers this preventive benefit.

Yazbek got the diagnosis eight years ago and has noticed declines. She uses a journal and calendar to help track her life, unlike her grandmother, who posted sticky notes everywhere to remember things.

The new drug is the first source of hope in a long time, and Yazbek said she is doing what she can to moderate her symptoms and qualify for it.

"If I get too complacent, then I get depressed and get in a funk that way and that makes my memory bad," she said. It also hurts her memory "if I try to do too much, which I'm known to do."