We’re now 20 years into what we might call the “amyloid era” of Alzheimer’s research and treatment. Yet, by most accounts, the hundreds of millions of dollars poured into Big Pharma drug trials since the landmark 2006 study that linked cognitive decline to the amyloid beta protein have produced a good deal more hype than hope.
As Charles Piller recounts in STAT News, that study was retracted in 2024 after critics uncovered doctored scientific images that had been used to support the results, but the FDA by that time had already approved three drugs that had demonstrated only minimal success in delaying dementia. One of those drugs, aduhelm, was subsequently pulled from the market after its side effects — including dangerous brain bleeding — became too obvious to ignore.
While those headlines have faded from public view and the uptake of “safer” amyloid-fighting drugs has gradually increased, some scientists now argue that focusing solely on the role of one particular protein — or one treatment approach — makes little sense.
“You can’t look at brain tissue and believe beta amyloid has nothing to do with it. It’s absolutely everywhere,” Vanderbilt University neuroscientist Matthew Schrag, MD, PhD, tells Piller. “But we’ve got lots and lots of patients who have tons of amyloid . . . with normal cognition. Biology is trying to tell you that there’s clearly more to the story.”
But, as Piller points out, the amyloid theory has lodged itself so pervasively in research circles that other treatment approaches have been largely ignored. He quotes Lon Schneider, MD, a University of Southern California amyloid-vaccine researcher, who argues that boosters of these drugs have been strategically overhyping their effectiveness for years.
“Lecanemab offers just a tiny effect after 18 months. But its advocates use dream statistics to project forward,” he contends. “‘We will see a bigger effect,’ they say. Then the message becomes ‘proof’ that people benefit for years, and many will be ‘survivors.’ The study wasn’t designed to show long-term outcomes. . . . But if you say it long enough, you will believe it.”
And if enough people believe it, more-promising treatment alternatives get underfunded and overlooked. A 2023 Brown University study, for instance, seems to have attracted little attention, despite finding that nondrug, collaborative-care treatment of Alzheimer’s patients led to fewer nursing home admissions and an improved quality of life — all at a much lower cost — when compared with those treated solely with aduhelm.
The collaborative-care treatment approach features a holistic combination of services, ranging from counseling and care managers to individualized care plans and skill-building resources.
The Brown University study was released at a time when officials at the Centers for Medicare & Medicaid Services (CMS) were mulling over the budget-busting consequences of covering the costs of Alzheimer’s drugs. Lead study author Eric Jutkowitz, PhD, argued that the cost-effectiveness of collaborative-care services offers a better option.
“Now that we can show that these effective interventions can also save money, it just makes sense to find ways to make them available to more families,” he said. “These interventions can be used to help people with dementia starting today.”
The CMS response was to cover the amyloid drugs and create a collaborative-care funding pilot (GUIDE); however, critics have described the project as unnecessarily complex, limited in scope, and underfunded.
As a result, these programs have struggled to gain traction amid the reimbursement chaos that characterizes our fractured healthcare system. There are exceptions, however. The Care Ecosystem, a University of California, San Francisco (UCSF), program that supports patients and caregivers with paid navigators who coordinate with clinical teams and connect caregivers to community resources, has been adopted by more than 50 healthcare systems across the country.
And researchers at UCSF earlier this month released the latest evidence demonstrating the effectiveness of this model. The study, based on data from earlier research that allowed them to create a simulated cohort of 1,000 patients — half suffering from early-stage Alzheimer’s and half with mild cognitive impairment (MCI) — found that collaborative care resulted in a longer, healthier lifespan when compared with those treated with only lecanemab.
“Our results demonstrate that collaborative dementia care is associated with a greater increase in [quality-adjusted life years] and significantly lower costs than 18 months of lecanemab,” lead study author Kelly Atkins, DPsych, writes in the journal Alzheimer’s and Dementia: Behavior and Socioeconomics of Aging. “Collaborative dementia care programs are poised to improve outcomes for the growing number of people living with dementia, alongside their caregivers.”
Researchers also touted the $48,000 saved per patient during the 18-month study period by shifting away from an amyloid-drug approach to a more holistic treatment model. It’s an approach Atkins argues would make dementia care more available to a much wider range of patients.
“Lecanemab is only indicated for patients with mild Alzheimer’s and MCI, but collaborative programs can be used for more advanced disease, as well as for the 20 percent to 40 percent of patients with other types of dementia,” she notes. “The drug may also be out of reach for rural residents living far from specialty clinics, and for low-income patients struggling to manage out-of-pocket costs.”
Will this be enough evidence to eventually persuade amyloid boosters to rethink their obsession with a flawed theory? Piller has his doubts. When he asked Dennis Selkoe, MD, perhaps America’s most celebrated Alzheimer’s researcher, whether the issues of price, side effects, and the limited benefits of the drugs have ever forced him to doubt his faith in this treatment approach, the Harvard neurologist said his opinion has never wavered. “Once you get into a line of thinking,” he admitted, “I’m sure that for all of us, you’re stuck on that line.”
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