2023 forecast: Health tech tools begin constructing the Alzheimer's treatment plan

Health tech is finding its footing on the developing path of Alzheimer’s disease care. With Biogen’s lecanemab expected to be approved by the Food and Drug Administration in early 2023, eyes are turning to tech to address the ‘disease of exclusion.’

With a nationwide neurologist shortage, technology is being leveraged to screen for the disease sooner when lifestyle alterations have the most impact and can buy time until new treatments are accessible. Many experts predict that with the drugs we all hope for still being five to 10 years away, tech may be able to help fill the gap.

Deputy CEO at Alzheimer’s Disease International Chris Lynch shared the stage with other experts in the field at the recent High-Level Forum on the Silver Economy put on by the United Nations and the World Economic Forum.

“Last year in our world Alzheimer’s report we used the phrase ‘a tsunami of demand,’” Lynch said. “The combination of the globally rapidly aging population, emerging treatments and a diagnostics revolution is effectively going to flip the market from a supply-side issue, a health system readiness issue, to a demand-driven issue.”

Biogen’s other new drug treating the disease, aduhelm, has been approved for coverage by the Centers for Medicare & Medicaid Services (CMS). The Access to Innovative Treatments Act, introduced to Congress earlier this month, would expand Medicare and Medicaid access to new AD treatments.

In late November, the New England Journal of Medicine published the results of a study showing that patients given lecanemab showed moderately less decline on certain cognition measures compared to patients given a placebo when used in early AD.

Following the initial excitement regarding lecanemab, two drug-related deaths were reported. Despite marring the news, experts still tout tech innovations in the field.

The arms race for workflow integrated digital diagnostic tools

For lecanemab to be effective, patients must be diagnosed early, a complex process for a ‘disease of exclusion,’ meaning all other possibilities, like geriatric depression, must be ruled out.

“We don’t have enough neurologists to assess and/or intervene in all the Alzheimer’s patients in our system,” said Steven Smith, M.D., chief scientific officer and senior vice president of AdventHealth during the Silver Economy forum. “We’re going into our primary care clinics and developing systems to have a digital cognitive exam going as close to the patient as we can.”

A slew of cognitive diagnostic tools already crowd the market, Phyllis Barkman-Ferrell, Eli Lilly's global head of external engagement for Alzheimer’s disease and executive at the Davos Alzheimer’s Collaborative, told Fierce Healthcare. What is needed is lower-cost tools that can scale and fit into doctors’ workflow at primary care appointments.

“With 10,000 Baby Boomers turning 65 every day, your costs are going to skyrocket so you've got to use technology to task shift,” Barkman-Ferrell said.

Cognitive assessment tech that has been 510(k) cleared by the FDA include Cognigram by Cogstate, the Linus’ clock draw test and Cogniview which is being employed in pharmacies. However, some of these tests are not integrated into physicians' workflow and are not culturally agnostic. There are also complaints that these tests monopolize physicians’ time.

Neurotrack provides a culturally-agnostic three-minute digital diagnostic tool that can be done at home and is directly integrated into electronic health records systems.

“Until recently, payers didn't pay for treatments,” Elli Kaplan, founder and CEO of Neurotrack, told Fierce Healthcare. “The providers weren't going to offer a task to someone where there wasn't a treatment. Now, everything is shifting.”

With patients experiencing wait times up to 21 months to see a neurologist, Kaplan expects the burden of diagnosis will be passed to primary care doctors armed with digital tools.

For those with a diagnosis, Neurotrack’s Cognitive Health Program was the most effective tool on the market before lecanemab entered the field, according to Neurotrack. Their research showed that the tool led to a 7% increase in cognitive improvement while depression and anxiety decreased by 50%.

“This goes hand in hand with any kind of drug,” Kaplan said. “For those who want to do whatever they can before they need a drug, it's very valuable.”

Currently, free tools that patients can use on their own include My Brain Guide by Us Against Alzheimer’s, which screens for cognitive impairment and provides resources, or AARP’s Staying Sharp.

Eyenuk is proposing a different digital approach. The company, which offers the only FDA-approved tool to detect more than mild diabetic retinopathy (DR) using retinal images and AI, has been working to diagnose AD before symptoms arise.

The company received a grant from the National Institutes of Health in 2019 to expand its AI eye screening platform for neurodegenerative disease detection.

Chief executive officer Kaushal Solanki told Fierce Healthcare that Eyenuk is looking at a set of vascular markers to enable early detection with an AI tool capable of characterizing retinal microvascular changes.

“When people actually use these cognitive tests on iPad or whatnot, functional people’s brains are already affected to some level,” Solanki said. “We want to catch this even prior to that when it is just structure, and it hasn't affected people's cognitive abilities yet.”

Solanki imagines the fundus cameras already deployed in primary care offices being used at annual appointments to test for DR in patients with diabetes, macular degeneration in patients over 55 or 60 depending on their ethnicity as well as glaucoma and cardiovascular disease down the road.

Solanki also believes that Eyenuk’s AI technology can help screen for the ideal patients for AD drug trials. “Diagnostic tools like this can in turn help determine which patients will benefit from therapies and help drive innovation in drug discovery as well,” Solanki said.

Moving the bottleneck to primary care treatment: How technology can ease the burden

Health data startup Komodo Health has found that patients ages 45 to 65 have already seen an 18% increase in early-onset AD diagnosis while patients over the age of 89 saw a 27% decrease in diagnosis, pointing to testing being done at earlier ages.

Komodo’s healthcare map can be used by providers to reveal health trends throughout the country. For AD, Komodo found that women are diagnosed with the disease two times more than men.

Usha Periyanayagam, M.D., head of clinical product at Komodo told Fierce Healthcare that a treatment bottleneck can be mitigated by data-informed targeting of the patients most at risk to develop the disease at younger ages.

“Whenever a new drug is released, people get very enthusiastic, but how does it actually have an impact as it has to be taken by patients who need it,” Periyanayagam said. “The role I see in tech is in bridging that gap. There's a lot of tech that could be used in finding patients, diagnosing them, training the PCPs to treat them correctly and then actually encouraging them and helping them get access to the right medications at the right time.”

Dr. Reza Hosseini Ghomi, chief medical officer at BrainCheck, thinks at the very least, new drugs in 2023 will help decrease stigma and ignite the use of treatment paths.

“If you were having this conversation with me in the '70s and we were talking about cancer, no one wanted to give anyone a cancer diagnosis because it was like a death sentence,” Ghomi told Fierce Healthcare. “Dementia, it feels like it's in the '80s.”

As primary care docs become aware of treatments and health tech testing tools, Ghomi warns that the bottleneck that once resided at the testing phase will move to treatment.

Along with a digital screening tool, BrainCheck provides clinical decision support and cognitive care planning tools. The care tool helps clinicians build, document and provide a plan for post-diagnosis. The tool’s data collection is designed around CMS’ guidelines to ensure Medicare reimbursement.

“The field is still sort of young, the average neurologist doesn't know all that much about dementia,” Ghomi said. “Tools like ours integrate the digital therapeutic piece so we make it comfortable to just diagnose dementia until patients meet with a specialist.”