FDA OKs Alzheimer's drug, which may not be available soon, and carries some risks; UK testing on patients with marker of disease

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Kentucky Health News

The U.S. Food and Drug Administration has approved a drug that has been found to help people in the early stages of Alzheimer's disease and is being studied at the University of Kentucky.

Lecanemab, to be marketed as Leqembi, has been approved through an accelerated approval process. It is to be used for Alzheimer's patients who have mild cognitive impairment or are in the mild dementia stage of the disease, the population that was studied in clinical trials -- which showed the treatment effectively removed amyloid beta plaque, a key marker of Alzheimer's disease, from the brain. The phase 3 trial, of nearly 1,800 people with early Alzheimer's and evidence of amyloid, found that those who got lecanemab for 18 months had a 27% slower cognitive decline than those who got a placebo.

"Longer trials are warranted to determine the efficacy and safety of lecanemab in early Alzheimer’s disease," the study authors reported in The New England Journal of Medicine, noting some "adverse events." The Columbus Dispatch reports that after the study concluded, two patients who remained on the drug died, both were on blood thinners. Marrwan Sabbagh, a neurologist and Barrow Neurological Institute researcher who analyzed the safety of lecanemab on behalf of its manufacturer, told the Dispatch that the deaths of patients on blood thinners "continue to be explored" and that such patients "might need some further consideration."

The Dispatch also noted that the FDA approval came two days after researchers detailed a death possibly linked to the drug. Despite the risks, the Dispatch reports, "Sharon Cohen, a neurologist and director of the Toronto Memory Program, said patients might be willing to accept the drug's risks for benefits such as recognizing loved ones, staying active, or performing everyday tasks."

UPDATE, Jan. 14: The trial found brain swelling and hemorrhage, respectively, in nearly 13% and 17% of the patients who received lecanemab, and only 2% and 9% of the placebo group, National Geographic reports: "Of the patients who took the drug and experienced brain swelling and hemorrhage, roughly 3% developed symptoms like headache, dizziness, and confusion. The others exhibited no symptoms, despite the swelling and bleeding. Matthew Schrag, a neurologist at Vanderbilt University, told National Geographic that could suggest that taking lecanemab is largely safe, “but we don’t know that.”

The Japanese drug firm Eisai, which developed lecanemab in partnership with Biogen, said in a news release that it will price the treatment at $26,500 per year for bi-weekly doses. The Wall Street Journal reports that lecanemab will be out of reach for most U.S. patients in the coming months because Medicare will only pay for this type of Alzheimer's drug for patients enrolled in a "government-sanctioned clinical trial, and no such studies are ongoing or planned." The Alzheimer's Association patient-advocacy group has asked the Centers for Medicare and Medicaid Services to reconsider its policy. 

UK study

Researchers at the University of Kentucky are researching lecanemab to see how it works on people who have no cognitive symptoms of Alzheimer's disease but have the amyloid protein that forms plaques that disrupt brain function, called "preclinical AD."

UK says the study is the first Alzheimer's disease trial to recruit people as young as 55 who are at risk of developing symptoms of the disease as they get older.

The trial still needs study participants and researchers want to make sure the opportunity is available to a wide range of the population.

“We especially want to reach out to those that have experienced health care discrimination,” said one researcher, Dr. Greg Jicha. “If you live in a rural area or are a person of color, you should know that we value you as much as we do everyone else. An effort this important needs to be available to everyone.”

To learn more about the study, call 1-800-AHEAD-70 or to find a trial site location enrolling near you, visit www.AHEADstudy.org. Learn more about enrolling in aging studies at UK's Sanders-Brown Center on Aging here.

UPDATE, Jan. 16: For a Q and A about the drug, click here.