| The Science Is Ready, but Is the System?

| Mark Swartz

| Alzheimer’s Disease kills about 120,000 Americans a year. My mother was one of the victims, so naturally I follow the medical research, but even the most revolutionary scientific breakthrough falls short if our healthcare system isn’t keeping pace.

In this conversation with Michael Brown, director, Future of Aging, Milken Institute, where he leads the Alliance to Improve Dementia Care, we discuss two blood tests recently approved the FDA as well as the findings of two reports: Mind the Gap: Investing in Dementia as an Opportunity to Extend Healthspan (2025) and Advancing Blood-Based Biomarkers for Alzheimer’s and Cognitive Care (2026). This interview has been edited for length and clarity.

Your report looks at readiness across the health system. What did you find?

We looked at readiness levels across five domains, asking primary care doctors, specialists, and health plans where they stand on adopting these tests. Milken isn’t setting clinical thresholds — that’s for professional round tables and the FDA, who’ve already said what “good” looks like: roughly 90 percent sensitivity and specificity on detecting amyloid. Our job is more commercial: what will it take to get these tools into real use?

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We asked people to rank readiness from one (insufficient, purely experimental) to five (fully sufficient, already routine). The clearest lag is payer coverage. Insurers are largely approving these tests claim by claim rather than issuing full policies that spell out when the test is covered. That uncertainty makes physicians hesitant, because they end up having a cost conversation they’re not equipped for: “This is a new test I want to try, and I’m not sure what it will cost you.” For a price-sensitive older adult, that’s often enough to decline the test — which is itself a bad outcome.

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Why is Alzheimer’s diagnosis more fraught than other disease-detection processes?

Partly because we’ve never had a test like this before. We’re used to routine bloodwork — cholesterol, triglycerides — but a brain-health marker doesn’t yet feel like something you casually add to an annual panel. That said, the format is actually an advantage: physicians already know how to order and interpret blood tests, and patients are used to giving blood. Compare that to the current standards — a PET scan, which can feel intimidating, or a cerebral spinal fluid lumbar puncture.

Where we are right now is figuring out who the right patient is: someone symptomatic with a high pretest probability of being amyloid-positive. Age matters here. A 55-year-old who’s otherwise healthy but had one concerning episode will get a less reliable result than an 80-year-old who’s been progressing and has a much higher baseline likelihood of amyloid buildup.

person holding a blood sample in a test tube
Photo by Los Muertos Crew on Pexels.com

Your report also scored health equity — how broadly available this could be to patients and families. How did that come out?

That was another low score — and largely concentrated in academic medical centers. We highlighted four systems doing this well: Wake Forest, Kansas, Emory, and Indiana University. All four are academic health systems with existing Alzheimer’s research centers, so they were already running clinical trials and could translate that infrastructure into routine care once a test cleared. A community neurology practice that isn’t on the cutting edge takes longer to catch up.

Access is a real constraint for PET scans — you generally need to be within about two hours of a scanner to get the tracer and complete the scan in time, so it’s not evenly available. A blood test, by contrast, could eventually be done at home or by a phlebotomist who comes to you, which is a real equity gain. Cost should come down over time, but right now, depending on the test and a patient’s coverage, out-of-pocket cost share runs somewhere between $250 and $650. Physicians generally don’t want to be the ones having that financial conversation. Dr. Cara Leahy, a physician in Michigan I interviewed for the report, put it well: suddenly she’s talking about a patient’s finances when the conversation should be about their health — and patients get uncomfortable saying they’re worried about the cost.

There’s a commercial angle too. Lab manufacturers want clarity from payers before they bring a test to market, so they know where to focus. When coverage is decided claim by claim, outcomes depend heavily on whether a given physician’s office knows how to code and advocate for the test. That unevenness is part of what limits access to the more sophisticated, well-resourced centers.

What’s the underlying urgency here — why does timing matter so much?

The anti-amyloid drugs available today only work in the earliest stages of the disease — mild cognitive impairment and mild dementia due to Alzheimer’s. Right now, people are typically diagnosed too late for that window. Roughly half of people are diagnosed at the mild stage, but the other half are already at moderate or severe — too late for today’s treatments.

Beyond drug eligibility, what’s the value of just getting an accurate diagnosis?

Most people who go through this testing process won’t end up qualifying for anti-amyloid therapy. But there’s still real value in the test itself — either ruling out Alzheimer’s, or confirming it. If someone doesn’t qualify for the drug, they may be able to enroll in a clinical trial, or at minimum, they and their family gain time to plan. Part of what we’re pushing payers to do is stop tying coverage decisions strictly to anti-amyloid drug eligibility, and instead recognize the other value these tests deliver: faster diagnosis, avoided unnecessary testing, and better-informed care decisions.

It’s also worth saying: a negative result has real value on its own. If amyloid isn’t detected, that rules out an Alzheimer’s-driven cause and points a physician toward other explanations for cognitive symptoms — a vitamin deficiency, a thyroid condition, or another neurodegenerative disease like frontotemporal or Lewy body dementia. That’s actually the specific approved use for the Roche test: a rule-out tool for primary care. The other FDA-cleared test is approved for the opposite role — ruling Alzheimer’s in, in a specialty-care setting. Not every biomarker test does the same job, which adds a layer of physician education that still needs to happen.

Why does this issue matter to you personally?

I got into brain health through my brother, who’s now a neurology resident;  we worked together on non-invasive brain stimulation research for Parkinson’s disease. More recently, my great-uncle passed away from dementia, and it was one of those situations that felt too taboo to talk about openly, even as I was becoming a brain-health expert myself. I remember wanting to ask: what type of dementia does he have? What stage? Does he qualify for treatment? People don’t ask those questions the way they would about a cancer diagnosis, where the natural follow-up is “what type, what stage, is it treatable.” A dementia diagnosis tends to feel like an automatic stage-four sentence, even though many people are actually caught at the mild stage — just not usually early enough to access today’s treatments.

That’s the whole point of blood testing: catching people earlier, at the most subtle signs of cognitive change, before the disease has progressed past the point where treatment can help.

Michael Brown

Mark Swartz is publisher of Aging in America News.


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