Digital tools, early detection, and better insurance policies can address the coming wave of cognitive decline.
At the 2021 Alzheimer’s Association International Conference (AAIC) researchers from the University of Washington announced their projection that the number of people living with dementia worldwide will triple from an estimated 57 million in 2019 to 152 million by 2050, driven by a population that is both increasing and aging. Other researchers at the meeting reported that 350,000 people under the age of 65 develop dementia every year.
Is the world prepared for this growing burden?
“Dementia is our greatest long-term medical challenge,” says Hilary Evans, chief executive of Alzheimer’s Research U.K. “These striking figures lay bare the shocking scale of dementia across the world. Today there are already 57 million people—too many—living with this devastating condition, and we need to see concerted global action to avoid this number tripling.”
Such calls for transforming the future mean little to Sylvia, who is 98 and lives on Long Island. She is one of an estimated 6.2 million Americans currently living with Alzheimer’s disease, the most common cause of dementia among older adults.
For the last 10 years, Sylvia, who at one time was a stockbroker, has been able to live at home with her 103-year-old husband, who was a successful healthcare professional. She has the assets to afford home care and not be in a nursing home. She also has a long-term care policy which pays many of the home care expenses, and a support system including two sons who are physicians, who monitor her care daily.
Like many patients with Alzheimer’s disease, Sylvia is most comfortable in the familiar surroundings of her home. At home, she has 24/7 skilled nursing care and two home health aides who feed, clothe, and bathe her and perform other activities of daily living. Sylvia, who is wheelchair- and bed-bound, also gets physical therapy for degenerative arthritis which limits her range of motion.
I have known Sylvia since I was 11. She recognizes me but does not know my name. Sometimes she calls me by the name of her dead brother (which she often calls her sons as well). But she does not exhibit the paranoia which often leads a person with Alzheimer’s to think their spouse is cheating on them or that people are stealing from them.
Proto.life asked experts in companies and at universities: What sort of solutions are emerging or are anticipated to address this coming pandemic of dementia and to help future generations of people like Sylvia maintain their cognitive health longer?
Better treatment options
Dementia is a general term for a decline in mental ability severe enough to interfere with daily life—and it’s a leading cause of death. According to the Centers for Disease Control and Prevention (CDC), Alzheimer’s disease alone is the fifth leading cause of death for adults 65 and older, and the sixth leading cause of death for all adults. The CDC notes that while the death rates for Alzheimer’s disease are increasing, heart disease and cancer death rates are on the decline in the United States due to the better treatments available and lifestyle changes.
Once somebody is diagnosed with heart disease or cancer, there are usually lots of treatment options—blood pressure drugs, cholesterol lowering drugs, lifestyle modifications, surgeries, radiation therapies, immunotherapies, therapeutic vaccines, and even some vaccines like Gardasil to prevent cervical cancer.
The same is not true for dementia, which lacks effective drugs to prevent, treat, or cure it. Despite over $42 billion poured into research since 1995, new drugs and treatments for cognitive decline are elusive. And many a researcher and pharma executive have sacrificed their careers in the search of that blockbuster solution.
The first drug to treat Alzheimer’s was not approved until 1993. Since then, a few more drugs have been approved to treat the symptoms but not the cause of the disease. Then in June of 2021, the FDA approved Aduhelm (aducanumab), the first new drug approved for Alzheimer’s since 2003 and the first drug ever approved that was designed to target the underlying cause of the disease. However, many in the medical community, including the FDA’s own expert advisory panel, opposed the approval decision, arguing the clinical trial data did not conclusively demonstrate that aducanumab could slow cognitive decline.
Last year, the NIH added $300 million to the federal budget for dementia research, raising the annual spend to $3.1 billion.
But with no real pharmaceutical cure for dementia on the horizon, the medical community has begun to focus more on detection and preventative measures.
Clinical detection and prevention
Comparing dementia detection to that of cancer or heart disease is like comparing rags to riches. There are a wealth of ways doctors can measure your heart health: by checking your cholesterol, doing an electrocardiogram, ordering a calcium CT, or giving you some other screening test, and people can monitor their own blood pressure at home with a commercial arm cuff (and soon, your smart watch). There are also lots of ways to detect different types of cancer—blood markers, genetic markers, imaging tests, mammograms, CT scans, and colonoscopies—including some screens effective at early detection when the cancer may be more treatable.
Up to 40% of dementias could be prevented or delayed by modifying risk factors.
This is not the case with Alzheimer’s disease, which had no approved blood test until C₂N’s PrecivityAD test was put on the fast-track to FDA approval in 2020. Brain imaging lacks the resolution to effectively detect dementia.
The good news is that even if we can’t always detect it, we may be able to delay and possibly prevent the onset of dementia. The Lancet Commission on dementia prevention, intervention, and care determined that almost one third of risk factors for dementia are modifiable. In their 2020 report, the Commission noted that up to 40 percent of dementias could be prevented or delayed by modifying risk factors like high blood pressure, smoking, diabetes, obesity, lack of physical activity, poor diet, high alcohol consumption, low levels of cognitive engagement, depression, traumatic brain injury, hearing loss, social isolation, and air pollution.
The risk factors you cannot control are age, sex (women have a higher risk of developing Alzheimer’s disease than men), and genetics. The good news for society is that the “familial” or genetic component of Alzheimer’s disease accounts for only two to five percent of all cases.
Diagnosing dementia early is notoriously difficult, however. In fact, it is often hard to diagnose at any stage. Many people are not definitively diagnosed with Alzheimer’s, for instance, until after they die, and postmortems reveal telltale signs like neurofibrillary tangles. For some 10 percent of people with Alzheimer’s disease, even an autopsy is not enough, and the cause of their cognitive decline remains unexplained.
Typically, doctors assess people in their offices with standardized cognitive tests such as the Mini-Mental State Examination (MMSE) which measures orientation, word recall, attention and calculation, language abilities, and visual construction or the Mini-Cog, a three-minute test consisting of a recall test for memory and a scored clock-drawing test. But these tests may only effectively diagnose people who have already noticeably started losing cognitive ability. They must be administered by a health professional and provide only a snapshot of the patient’s experience. They cannot effectively stage a case of dementia the way a cancer diagnostic would—nor are they the same sort of smoking gun you would get with a high-resolution radiologic scan of a tumor embedded in a tissue. Additionally, current dementia diagnostic tools usually cannot identify people in the early stages of disease or determine whether someone will develop dementia years down the road. By the time patients receive a diagnosis, neurons have died, and brain anatomy has changed.
Digital detection methods
Given the lack of effective treatments for Alzheimer’s disease and dementia, medical technology firms are stepping in to fill the void. One of these is San Mateo, California-based Evidation Health, which was founded in 2012 and dreams of revolutionizing Alzheimer’s care through early detection with what they call “digital” biomarkers.
“Digital biomarkers of cognitive decline could alert us to the early stages of dementia before irreversible damage occurs,” according to Christine Lemke, the company’s cofounder and co-CEO. In 2018, Eli Lilly, Apple, and Evidation Health did a feasibility study to see if it was possible to identify cognitive impairment by analyzing the many types of digital data people inadvertently generate in their everyday lives. “The study showed we could use wearable or mobile technology to gather data from people not yet showing obvious clinical symptoms of cognitive decline,” Lemke said. Departures from this baseline digital phenotype could then alert clinicians earlier of any possible cognitive decline.
In July, 2021, Evidation announced a collaboration with Merck, to investigate the utility of remotely collected digital measures to detect and monitor the treatment of Alzheimer’s disease. The collaboration is focused on the identification of digital endpoints for Alzheimer’s that can be collected remotely to accelerate drug development. “The study will seek to test whether such data can be used to differentiate between populations and to understand variability and changes in digital measures across individuals and over time,” says Lemke. (Though it is worth recalling that relying on such “surrogate endpoints” with no direct evidence of drug efficacy is exactly why many in the medical community opposed the approval of Aduhelm last year.)
In February 2020, Alzheimer’s Research UK launched EDoN (Early Detection of Neurodegenerative diseases), with as its president the former U.K. Prime Minister, David Cameron. EDoN says their approach will allow the detection of neurodegenerative diseases 10–15 years before symptoms of dementia affect someone’s day-to-day life. They will use inexpensive, non-invasive digital tools such as wristbands and mobile apps to study behavioral and physiological measures like sleep, cognition, mood, navigation ability, gait, and heart rate. The clinical measures will be used to train machine learning AI models to detect patterns, or “fingerprints,” in the digital data, which are characteristic of specific diseases that cause dementia.
Venture capital-funded Linus Health is another digital health company moving into this space. The slogan of the Boston-based company is “making personalized brain health a reality for everyone,” and they are working with neurocognitive experts to develop a novel brain health monitoring platform. “Our platform will analyze several aspects of a person’s behavior to glean insights into their brain, and merge it with medical health records,” says David Bates, the company’s CEO. “We have a smartphone app that reminds users to do certain tasks and measures reaction time, voice and speech, gait, and other potential biomarkers of dementia.” The device’s built-in sensors can assess heel strikes, toe lifts, a person’s balance and walking speed, and other metrics that could reveal a declining mind, Bates says.
Linus Health is using a digital version of the classic clock-drawing test, the DCTclock, for cognitive assessment that can be easily administered at a doctor’s office in three minutes. “The DCTclock improves upon traditional cognitive tests,” Bates says, “and has the potential of providing an efficient tool for detecting early cognitive changes along the Alzheimer’s disease trajectory.”
A study published in the journal Neurology in July 2021 found that the DCTclock was effective in identifying the beginnings of Alzheimer’s disease pathology in cognitively normal individuals with no outward symptoms of dementia.
The company Savonix, based in San Francisco, has also developed a mobile neurocognitive assessment and brain health platform. It has been clinically validated and is used by patients, clinicians, and insurers worldwide. Built specifically for mobile devices, it ensures precise reaction time within milliseconds, which guarantees more accurate cognitive data results.
More data in real time
In 2020, Savonix teamed up with Fujitsu Connected Technologies Limited, one of the major smartphone manufacturers in Japan. The Savonix Mobile app is pre-installed on the Raku-Raku Smartphone F-42A and allows users to test their cognition across eight brain functions such as executive function, working memory, and impulse control. Users will immediately receive test results within the app.
The company claims that the Savonix Mobile app can detect mild cognitive impairment 93 percent of the time. At the 2019 Alzheimer’s Association International Conference, Mylea Charvat, the founder and former CEO of Savonix said that since lifestyle factors play a key role in the development of dementias, it’s important for cognitive screening solutions to test different brain functions so that they can “identify individuals when there is often still time to intervene and slow disease progression through lifestyle changes and behavior modification.”
But not everyone agrees that the app can diagnose dementia. proto.life asked Howard Fillit, the cofounder and chief science officer at the Alzheimer’s Drug Discovery Foundation (ADDF) his thoughts on this. “Apps can be useful for people to better understand their cognitive function. However, no app can diagnose dementia,” he says, “That can only be done by a physician after a clinical examination including cognitive testing, neuroimaging, and other tests.”
Fillit says the information gathered by sleep apps is an example of the limitations of health apps. “There are scores of apps to measure snoring and movement in bed, which are useful to know. But the only way to really diagnose a sleep disorder is by a formal sleep study that measures brain activity while a patient is asleep,” he says.
You need more than one datapoint, a multimodal approach, because people are not the same every day.
Nevertheless, he thinks the apps are helpful, and he believes in the near future, more sophisticated apps to measure cognition will be developed and validated, giving individuals and physicians a more holistic picture of a person’s cognitive state that can be tracked over time. “One advantage to apps is that they can give us data over time, compared to a single day’s test at a physician’s office. You need more than one datapoint, a multimodal approach, because people are not the same every day. If a person had a bad night’s sleep or was under a lot of stress, that can affect their cognition on the day the test is given. The idea is that these apps, when fully developed, will give patients and their doctors useful longitudinal data,” Fillit says.
Fillit’s own organization, ADDF, invests in a wide array of digital biomarkers for the early detection of Alzheimer’s and dementia through its Diagnostics Accelerator, a $50 million fund backed by ADDF cofounder Leonard A. Lauder, Bill Gates, Jeff Bezos, MacKenzie Scott, the Dolby family, the Charles and Helen Schwab Foundation, the Association for Frontotemporal Degeneration, and others. Their portfolio includes wearable devices, mobile and tablet apps, smart home systems, virtual and augmented reality platforms, and desktop and web apps.
Why not dementia insurance?
Given the looming explosion of dementia, you might wonder if insurance companies are jumping in to sell healthy people dementia insurance. They are, but not in the United States. Dementia insurance policies are sold in Japan and Korea. These policies supply benefits to customers who are diagnosed with early signs of dementia as well as covering costs such as transportation and the costs of searching for wandering dementia patients. According to a spokesperson for Tokio Marine & Nichido Fire Insurance Company, “Patients going missing is what makes their family members most anxious.” At the moment, not a single U.S. insurance company covers non-medical costs associated with dementia.
Asia is home to some of the world’s oldest populations, those ages 65 and above. At the top is Japan with 28 percent and more than 4.6 million people living with dementia. According to a survey on dementia conducted by Japanese-based pharmaceutical company Eisai of 224 men and women aged 40 and older, the highest source of anxiety was “personal or family member’s incidence of dementia” followed by “burden of nursing care on family” and “financial burden caused by dementia care.”
Sompo Japan Nipponkoa Himawari Life Insurance claims to provide insurance policies for those diagnosed with early signs of dementia. But if insured people develop the disease, they would receive lifetime benefits of only 250,000 yen or about $2,000.
In South Korea, Hanwha Life introduced a dementia policy that covers nursing fees for policyholders until they are 95. The premiums are fixed, and the plan has been so popular that around 110,000 people applied to purchase a policy within two months of its release. In fact, the initial demand was so high, the premium is now expected to increase or the coverage to shrink.
Samsung Life has a comprehensive nursing policy that covers fees for conditions dementia patients suffer from that affect their mobility and quality of life. The policy pays medical fees plus additional expenses and costs if long-term hospitalization is needed. The number of policyholders reached 42,000 the first month of launch. In the United States, both Medicare and private insurers will pay for some costs, such as tests, skilled nursing, and care in nursing homes for people who have Alzheimer’s or other dementias—but not assisted living at home, and there are no standalone dementia insurance policies you can buy in the United States.
Despite the grim statistics about Alzheimer’s disease and dementia, there are reasons to be optimistic including a better understanding of the genetics of Alzheimer’s disease, a blood test to detect Alzheimer’s, diagnostic tests that promise quicker and easier access to clinical trials, and the approval of Aduhelm which although not a miracle drug, may lead to better drugs in the future. Though none of these will change the outlook for patients like Sylvia who currently have Alzheimer’s disease, collectively they should help people in the near future.
Editor’s note: This story was updated on May 17, 2022 to correct the name of the cognitive test in the photo caption.