A new Alzheimer’s drug made history last week when it became the first approved medicine shown to consistently slow the memory-destroying disease. Now, Seattle researchers are looking for local participants to help understand just how early the drug can, and should, be introduced.
The global AHEAD study, funded by the National Institutes of Health with sites in the Puget Sound region, is recruiting Washingtonians ages 55 to 80 who don’t have Alzheimer’s symptoms, but could be at high risk of developing the disease. For this asymptomatic group, options for treatment remain limited, even with the Food and Drug Administration’s recent approval of lecanemab (sold under its brand name Leqembi), said Dr. Michael Rosenbloom, director of clinical trials at the University of Washington’s study site.
“If you were to start a drug like lecanemab in patients with moderate to severe disease, it’s probable the damage has already been done,” said Rosenbloom, who’s been working with patients with Alzheimer’s and related diseases since 2008. “It’s almost like having a cancer metastasized. Your treatment is going to be less efficacious if you start it in the latter stages, so starting as early as possible is important.”
The study aims to explore the limits and benefits of lecanemab by working with patients without symptoms but whose brains show signs of amyloid pathology, or evidence a certain protein is sticking together and forming plaques in the brain, which is one of the warning signs of Alzheimer’s, Rosenbloom said. Some of these brain changes associated with Alzheimer’s can begin up to 20 to 30 years before symptoms appear, he added.
During the course of the study, participants would receive IV treatment for about four years before researchers would analyze cognitive changes. If results come back showing improvements from the medicine, it could be a sign to more aggressively screen younger patients for Alzheimer’s changes, Rosenbloom said.
“Up until now, there’s been a bit of debate about, ‘Well, if you find that a patient has Alzheimer’s disease, what can you do about it?’ It’s quite limited,” he said. “Lecanamab is the first tipping point where we’re thinking about this disease differently … This is a huge sea change in the field.”
According to the Chicago-based Alzheimer’s Association, the number of Americans with the disease is growing fast. As of this year, more than 6 million Americans were diagnosed with Alzheimer’s, and the number of deaths from the disease has more than doubled in the past 20 years.
Lecanemab was manufactured by Japanese drugmaker Eisai, which received conditional approval from the FDA in January, according to The Associated Press. The agency granted full authorization after reviewing data from a larger, 1,800-patient study that showed the disease progression slowing by 27% over 18 months.
The medicine notably shows evidence of causing a biological change, meaning the drug significantly reduced the amount of amyloid that researchers could detect, Rosenbloom said. In clinical studies, some patients no longer had any detectable amyloid in the brain.
In comparison, more common Alzheimer’s drugs such as donepezil or memantine are more-or-less symptomatic treatments, he said. They’re developed to increase neurotransmitters that are lost in patients’ brains, but the benefits are usually modest.
“The hope is that by intervening early in this pathway, you may be able to save neurons and, as a result, slow cognitive decline,” Rosenbloom said.
Once the drug is released on the market, likely this fall, its prescribing information will include information about possible side effects such as brain swelling and hemorrhaging — problems seen with other plaque-targeting Alzheimer’s drugs, The Associated Press reported.
While lecanemab’s approval is a huge step forward in Alzheimer’s research and treatment, Rosenbloom added that it’s not a “magic bullet” that reverses all symptoms.
Still, he’s optimistic about the medicine, particularly because similar work is being done on other drugs that target amyloid accumulation and aim to remove it.
“When I see multiple drugs with a similar mechanism resulting in something that is consistently beneficial, that tells me that we’re on the right track here,” he said. “This is not a fluke.”
The AHEAD study will continue to recruit participants through the end of the year.
