NATIONWIDE — A promising new drug for patients with Alzheimer’s disease has emerged, slowing cognitive decline by 27 percent.

Eisai/Biogen’s lecanemab “slows progression of the disease,” said Meg Boyce, vice president of programs and services at the Hudson Valley chapter of the Alzheimer’s Association (AA). “It gives individuals more time.”

That’s time to spend with family and to deal with legal and medical questions. It’s time that patients can use to reach out and talk about the things they have always wanted loved ones to know.

In the U.S., 6.5 million people have Alzheimer’s disease, according to the AA. In Pennsylvania, the number is 280,000; in New York, it’s 410,000.

The disease causes memory loss, trouble with finding words or following directions, and difficulty communicating, swallowing and walking, according to the AA. It is terminal.

Lecanemab is not yet approved by the FDA, Boyce cautioned. But “this is tremendously exciting.”

The drug, like aducanumab before it, tackles the formation of beta amyloid. Brains of people with Alzheimer’s disease show—among other changes—beta amyloid proteins that have clumped together to form plaques.

Some researchers think that the plaques cause the disease, others that the plaques are an effect. What makes lecanemab important is that phase 3 trials showed that it slowed cognitive and functional decline by 27 percent, compared to a placebo group, according to a press release from Eisai/Biogen.

The decline was measured by the Clinical Dementia Rating-Sum of Boxes test.

The hope is to have FDA approval by the end of January, Boyce said.  

Lecanemab would be prescribed for people with Alzheimer’s-related mild cognitive impairment or with early Alzheimer’s disease.

For Boyce, a key difference in the lecanemab study is that 25 percent of the participants were Black or Hispanic.

“Hispanic and Black Americans are at a much higher risk” of the disease, she said. One of the goals of the AA is to make studies more diverse, to make sure that treatments will work for everyone.

Another study, using lecanemab as a preventative treatment, is currently enrolling patients, she said.

“Research shows that beta amyloid starts developing 15 to 20 years before symptoms actually show,” Boyce said. “Scans show a buildup” of the proteins. So a preventative treatment “would be a major game-changer.”

There are two other drugs, from Eli Lilly and Roche, in clinical trials now, she said. “We’re hoping [to see the results] in six to eight months,” and if all goes well, the three medications will give patients options for treatment.

Haven’t we been here before?

You’re thinking of Aduhelm.

Initial trials of Aduhelm, or aducanumab—also from Biogen—showed that it removed large amounts of amyloid, and phase 3 trials were started to test cognitive decline.

But in 2019, Biogen halted the trials, perhaps because Aduhelm’s “impact on the functioning of patients in earlier stages of Alzheimer’s was so meager that an expert panel voted 10-0 (an 11th panelist was uncertain) in November 2020 to advise FDA to reject it,” wrote Arthur Allen at Kaiser Health News.

Nevertheless, Aduhelm was approved provisionally by the FDA in 2021. It has been given nine years to demonstrate that it improves cognitive functioning.

The drug’s price of $28,200 per year has also slowed its use.

Information from khn.org/news/article/medicare-ruling-aduhelm-controversial-alzheimer-drug-critics/

Of course, there are challenges. Once approval is won, “cost and coverage are the two biggest question marks,” Boyce said.

A year’s worth of aducanumab, another Alzheimer’s drug that targets beta-amyloid proteins, is priced at $28,200 per year—which is down from its initial list price of $56,000.

A price hasn’t been set for lecanemab yet.

“We have to start looking at Alzheimer’s disease like cancer, as a terminal illness,” Boyce said.

Perhaps that would encourage Medicare to pay a larger share of the cost.

In any case, providing a way to slow the decline down will give patients not just time, but “a sense of hope,” she said. “Hope for their families.”