Alzheimer’s Care Could Change Overnight. Are We Ready?

Transforming Alzheimer’s diagnosis is no easy task, even when effective technologies exist.

More than a year after the first FDA clearance of a blood test for Alzheimer’s disease, the Milken Institute Future of Aging issued a report still seeking an answer to this basic question: What will it take to make blood tests the standard of care in Alzheimer’s disease?

Advancing Blood-Based Biomarkers for Alzheimer’s and Cognitive Care draws on a range of expert perspectives, a literature review, and patient focus group. It examines today’s diagnostic journey and overall health system readiness for making biomarker tests routine. The verdict? Implementation is lagging, but the system is primed for change.

One aspect of the report jumped out at me. According to the National Council of Dementia Minds, one of the groups consulted, the period prior to diagnosis is described by patients as the worst part of the illness. This is not only because of the symptoms, but also because of the uncertainty – not knowing what is causing the symptoms and what it means.

It’s hard to imagine if you haven’t gone through a disease like Alzheimer’s, but after the initial shock of a diagnosis, the clarity can bring relief. The Alzheimer’s Association ran a poll last year that found nearly 4 in 5 Americans say they would want to know their diagnosis before it starts affecting their daily life.

Cara Leahy, DO, of Memorial Healthcare (and APWG member) echoed this sentiment: “My first job as a physician is to diagnose, even if treatment is not an option.” The clarity of a diagnosis gives people time to plan and take a proactive approach to care, instead of waiting for a crisis. Testing can also surface concerns about related diseases like vascular dementia, where early action and positive lifestyle changes can significantly reduce risk.

The report scores health system readiness across five categories: clinical guidelines, tests fitted into the diagnostic journey, evidence in a form that payers will accept, coverage policies based on that evidence, and access that reaches beyond academic medical centers. On nearly every count, experts found encouraging momentum but a long road ahead.

Over the next year, the need for blood tests will likely grow. New data could soon show the possibility of amyloid treatment providing protective benefit in people without symptoms who are undergoing changes in the brain associated with Alzheimer’s disease. Two trials are currently studying this and are expected to report as early as 2027. If that day comes, we need to ensure the system is ready to move fast.

Identifying people who are not showing symptoms but could benefit from amyloid treatment will require screening cognitively normal people who might already have the proteins that cause the symptoms of Alzheimer’s. But Medicare is not allowed to pay for a new screening test unless ordered to do so by Congress.

The Alzheimer’s Screening and Prevention (ASAP) Act, a bipartisan piece of legislation pending in Congress, aims to solve this by giving the Secretary of Health and Human Services authority to extend Medicare coverage for FDA-cleared blood tests as a screening tool in people without symptoms.

This would address an important problem by making reimbursement predictable for seniors. But many of the systemic barriers to wider use among clinicians that Milken highlighted will still need to be solved. Broader reimbursement and training policies would be needed to empower primary care clinicians to effectively use the tests at scale. And many people eligible for treatment would be younger than 65 and rely on private insurance to cover testing and treatment.

Despite these challenges, I share Milken’s optimism in the potential for blood tests to transform Alzheimer’s care in America. And I applaud their work in bringing stakeholders together to collaborate and find a path to accelerate better care for more patients and families. You can read the report here.

Phil Coticelli is the Executive Director of the Alzheimer’s Policy Working Group.