CEO of Posit Science, developers of the BrainHQ brain training program. Focused on digital health and bringing science to the people.
Receiving a diagnosis of Alzheimer’s is one of the scariest pieces of news a person can face. While other medical diagnoses carry bad news for your health (e.g., cancer, heart disease or diabetes), a diagnosis of Alzheimer’s poses a unique threat to a person’s sense of self.
Given the seriousness of these diagnoses, you might think there would be high interest in detecting these diseases as early as possible. Likewise, you would think there would be enormous commercial opportunities for businesses that could integrate the science of early detection with the business of improving health outcomes and lowering costs.
And you’d be right for three of those serious medical diagnoses. We’ve had early detection of cancer for decades, ranging from regular mammograms to breakthroughs in blood testing like Gallieri, which can find free-floating cancer cells in the earliest stages of the disease. We monitor the risk for heart disease with everything from ECGs in a doctor’s office to the latest Apple Watch or Kardia card. And we can check blood sugar or A1c levels to measure the earliest signs of adult-onset diabetes.
The reason doctors want to detect these conditions early on—and the reason that insurers are willing to pay for it—is that we can lower the risk of disease progression. Early detection of breast cancer? Get treated with anti-hormonal medication and surgery before the cancer spreads. Heartbeat looking abnormal? Improve your heart health with medications, diet and exercise. High blood sugar? Change your diet and exercise, and, more recently, try to get your insurer to pay for Ozempic or Mounjaro.
So, how about Alzheimer’s? Shouldn’t science have given us a way to detect if someone is in the earliest stages of this disease? Where are the diagnostic companies and healthcare giants working on early detection of Alzheimer’s?
Well, not so fast…
Until recently, there was no way to determine if a living person had Alzheimer’s. The medical diagnosis required a post-mortem evaluation to determine if “plaques and tangles” were found at the anatomical level. And while doctors have defined a pre-Alzheimer’s condition called mild cognitive impairment (MCI)—where a person has cognitive loss but hasn’t yet declined far enough to meet the criteria for dementia—there is no biological test for MCI, which means it can be confused with other conditions (like delirium or vitamin deficiency) that don’t lead to Alzheimer’s.
This has meant that unlike cancer, heart disease and diabetes, there really hasn’t been a biological marker for early detection of Alzheimer’s.
You might be surprised to learn that for many doctors and patients, that was OK. Why? Because the only purpose of a diagnosis is to take clinical action. And while people could take action after an early diagnosis of cancer, heart disease or diabetes, there was no action they could take after an early diagnosis of Alzheimer’s. I was once told at a leading memory care center that the main purpose of an MCI diagnosis was to let the patient (and family members) know it was time to get their affairs in order—there wasn’t anything to slow or stop the progression of the disease.
But change is coming—and with it, challenges and opportunities for businesses interested in diagnostics.
A foreshadowing of this happened already, suggesting how this industry will develop. In 2012, Eli Lilly developed Amyvid, the first Alzheimer’s diagnostic—a radiolabeled antibody that in combination with a high-tech brain scan could determine if a living person has an accumulation of amyloid plaques in the brain.
This was an incredible scientific achievement, but it met with a commercial thud. Medicare declined to cover the expensive scans—not because they didn’t work but because they didn’t matter. There was no action that a physician could take based on the scans, and so Medicare said the benefits didn’t justify the costs.
That same problem has played out with each new approach for early detection of Alzheimer’s. Some approaches have involved computerized cognitive testing, with careful normative data sets and statistics to identify people who test below their expected performance. Other approaches have involved blood-based biomarkers, including the neurofilament light protein and markers for amyloid.
But none will see commercial success unless patients, physicians and, most importantly, Medicare see that the diagnosis is helpful—that it leads to changes in treatment, better health outcomes and lower costs. Just knowing isn’t enough.
One way out of this conundrum might be new pharmaceuticals. The newest generation of approved medications for Alzheimer’s disease can only be prescribed to people who show amyloid in their brains—as detected with that expensive brain scan. That connection is what finally led Medicare to pay for those brain scans—because the results can influence whether a patient can be prescribed these drugs.
Another way forward is the emergence of the new science of dementia prevention. More and more scientific studies have shown that people can act to lower the risk of dementia with brain training exercises, eating a brain-healthy diet, getting physical exercise, getting enough sleep, lowering stress, and building and maintaining social connections. In 2020, the Lancet Commission found that 40% of Alzheimer’s and dementia cases might be prevented with lifestyle changes.
That means new technologies that provide early detection of Alzheimer’s and associated risk factors now have value—because people can take action to change their fate. Instead of early detection just telling a person they should get their affairs in order, it can now provide the impetus for a person to pursue a brain-healthy lifestyle. It’s worth it for Medicare (and health plans) to pay for those diagnostics and treatment plans involving dementia risk reduction activities.
It’s this connection that will (finally) unlock the value in early detection of Alzheimer’s. Businesses that can deliver accurate early detection coupled with driving changes in patient behavior to lower risk will have an enormous business opportunity ahead of them—as well as the opportunity to help millions of people.