Cognitive speed training over weeks may delay the diagnosis of dementia over decades

A National Institutes of Health (NIH)-funded study that followed adults age 65 and older over 20 years has linked a specific cognitive training regimen to reduced diagnoses of Alzheimer disease and related dementias (ADRD). While the authors assessed three different kinds of training, only one, which challenged participants with rapid object detection tasks, was associated with a 25% lower rate of dementia diagnosis, as indicated by Medicare claims data.

“This study shows that simple brain training, done for just weeks, may help people stay mentally healthy for years longer,” said NIH Director Jay Bhattacharya, M.D., Ph.D. “That’s a powerful idea — that practical, affordable tools could help delay dementia and help older adults keep their independence and quality of life.”

“The findings reported here suggest that moderate cognitive training could delay the onset of dementia over subsequent years. There is still more research to be done to determine about how this works, but this promising lead may move the field further into developing effective interventions to delay or prevent onset of dementia,” said Richard Hodes, M.D., director of the NIH’s National Institute on Aging (NIA), which funded this research.

As part of a now completed clinical trial, participants were randomized into cognitive training sessions, each lasting 60–75 minutes twice a week, over five to six weeks in 1999. Then, half of the participants were randomized into another round of training 11 and 35 months later. The study authors evaluated the effect of each training regimen by analyzing Medicare data collected as recently as 2019 from 2,021 study participants.

The interventions were designed to improve one of three kinds of cognitive function: memory, reasoning, and visual speed of processing. The only subgroup in this study that experienced delayed dementia diagnosis was the one that received speed training followed by additional training at a later date, designed to enhance the effect.

The speed training task first asked participants to identify which of two objects appeared in the center of a computer screen. The visual presentation of the stimuli became shorter over time until participants achieved a certain level of performance. Next the training asked participants to identify the central target, while concurrently detecting a similar peripheral target which appeared over increasingly short durations. Lastly, the position of the peripheral target around the computer screen varied, with each additional phase of the task making it more difficult.

Unlike memory or reasoning training, speed training sessions were unique, as difficulty of the tasks increased adaptively to make the tasks more difficult as an individual’s performance improved over time. The authors note that this adaptive nature, which was exclusive to speed training, could partly explain the standout findings from this group.

Another potential driver for the delayed diagnosis may be the speed training regimen’s tendency for engaging automatic, unconscious thought rather than slower, deliberate thinking. The specifics of how one would lead to the other, and why the other two training types did not yield the same results, are questions that still need to be addressed. The researchers suspect that speed training may synergize with lifestyle interventions associated with lowered risk of cognitive decline such as increased physical activity and improved diet.

“This work conveys a clear message but also leads us to ask many new questions. We are keen to dig deeper to understand the underlying mechanisms at play here, but ultimately this is a great problem to have,” said Marilyn Albert, Ph.D., the corresponding study author and director of the Johns Hopkins Alzheimer’s Disease Research Center at the Johns Hopkins School of Medicine.

This research was supported by NIA through grants R01AG056486, U01AG014260, U01AG014282, U01AG14263, U01AG14289, and U01AG014276 and by the National Institute of Nursing Research (NINR) through grants U01NR004507 and U01NR004508.

About the National Institute on Aging (NIA): NIA seeks to understand the nature of aging and diseases associated with growing older, with the goal of extending the healthy, active years of life. https://www.nia.nih.gov.

About the National Institutes of Health (NIH): NIH, the nation's medical research agency, includes 27 Institutes and Centers and is a component of the U.S. Department of Health and Human Services. NIH is the primary federal agency conducting and supporting basic, clinical, and translational medical research, and is investigating the causes, treatments, and cures for both common and rare diseases. For more information about NIH and its programs, visit www.nih.gov.

NIH…Turning Discovery Into Health®

Reference

Norma B. Coe et al. Impact of Cognitive Training on Claims-Based Diagnosed Dementia Over 20 Years: Evidence from the ACTIVE Study. Alzheimer’s & Dementia: Translational Research and Clinical Interventions. 2026 DOI: https://doi.org/10.1002/trc2.70197

Cognito Therapeutics completes enrollment in landmark Alzheimer’s trial

Cognito Therapeutics announced it has completed enrollment of 670 participants in the HOPE Study, a pivotal clinical trial evaluating the safety and efficacy of its investigational neuromodulation device, Spectris, for patients with Alzheimer’s disease.

According to the company, the HOPE Study (NCT05637801) is the largest medical device trial ever focused solely on Alzheimer’s disease. The randomized, double-blind, sham-controlled study spans 70 sites across the U.S. and includes a 12-month treatment phase followed by a 12-month open-label extension. Participants will use the device, which delivers synchronized light and sound stimulation at the 40Hz gamma frequency, in their homes daily.

“Completing enrollment in this landmark trial marks a major step forward in our mission to deliver a better treatment option for people living with neurodegenerative conditions, like Alzheimer’s,” said Christian Howell, CEO of Cognito Therapeutics. “We’re proud to lead one of the largest and most advanced device studies in the history of Alzheimer’s disease.”

The trial builds on promising results from the OVERTURE feasibility study, which showed a 76% reduction in cognitive decline, a 77% reduction in functional decline, and a 69% reduction in whole brain atrophy over six months. The HOPE Study aims to confirm these findings in a larger population, using changes in ADCS-ADL and MMSE scores as its primary endpoint.

“There is an urgent need for safe, effective, and scalable treatments for Alzheimer’s,” said Ralph Kern, chief medical officer at Cognito. “Our technology is non-invasive, has shown strong early signals in functional and structural outcomes, and may be uniquely suited to deliver a home-based therapy.”

The Spectris AD system remains investigational and is not currently available for commercial use.

Non-invasive innovations advance alzheimer’s treatment landscape

Alzheimer’s disease affects more than six million Americans and remains one of the most challenging neurodegenerative disorders to treat. While drug therapies have gained attention in recent years, non-invasive treatments—like neuromodulation and digital therapeutics—are rapidly emerging as complementary or alternative options.

Gamma-frequency stimulation, such as the 40Hz sensory stimulation used in Cognito’s device, is drawing interest after animal studies demonstrated that it may reduce amyloid plaques and improve cognitive performance. These findings have encouraged exploration of light and sound therapies in human trials, targeting brain wave entrainment to restore neuronal health.

In parallel, advancements in home-based monitoring and remote clinical trials are expanding access and convenience for Alzheimer’s patients and caregivers. Wearable EEGs, digital biomarkers, and mobile apps are enabling researchers to track disease progression with greater precision, without the burden of frequent clinic visits.

Non-invasive brain stimulation using technologies like transcranial magnetic stimulation (TMS) and transcranial direct current stimulation (tDCS) is also being studied, although these approaches typically require in-clinic sessions. The promise of fully home-based systems like Spectris lies in their scalability and ability to integrate into daily life, reducing the burden on both patients and caregivers.

While no single approach is expected to reverse Alzheimer’s, the integration of non-pharmacologic therapies with traditional treatments may ultimately reshape how the disease is managed, offering hope for improved quality of life and slower decline.

FDA clears first blood-based diagnostic test for Alzheimer’s disease

The U.S. Food and Drug Administration (FDA) has cleared the first blood-based diagnostic that helps physicians determine whether cognitive-impaired patients carry the amyloid plaques that signal Alzheimer’s disease, the agency announced Friday.

The Lumipulse G pTau217/β-Amyloid 1-42 Plasma Ratio test from Fujirebio Diagnostics, Inc., measures two proteins in plasma and calculates their ratio, providing an indicator of amyloid pathology in adults 55 and older who show signs of dementia. The decision gives clinicians a less-invasive, more widely accessible alternative to amyloid PET scans or cerebrospinal fluid taps, both costlier and more burdensome procedures.

FDA officials hailed the clearance as a chance for early detection for a debilitating disease with rising patient counts.

“Alzheimer’s disease impacts too many people, more than breast cancer and prostate cancer combined,” said FDA Commissioner Martin A. Makary, M.D., M.P.H. “Knowing that 10% of people aged 65 and older have Alzheimer's, and that by 2050 that number is expected to double, I am hopeful that new medical products such as this one will help patients.”

How FDA clearance was obtained

Clearance relied on data from a 499-patient, multicenter trial of cognitively impaired adults. The blood test correctly identified amyloid plaque in 91.7% of patients who were positive by PET scan or cerebrospinal fluid testing and correctly ruled it out in 97.3% of patients whose imaging or CSF results were negative. Fewer than one in five samples produced indeterminate readings.

“Nearly 7 million Americans are living with Alzheimer's disease and this number is projected to rise to nearly 13 million,” said FDA Center for Devices and Radiological Health Director Michelle Tarver, M.D., Ph.D, in the news release. “Today’s clearance is an important step for Alzheimer’s disease diagnosis, making it easier and potentially more accessible for U.S. patients earlier in the disease.”

Fujirebio Diagnostics’ President and CEO Monte Wiltse said physicians currently lack effective, accessible and noninvasive diagnostics for Alzheimers, and the test offers a solution for early detection. “As part of our worldwide commitment to improve the diagnosis and treatment of [Alzheimer’s disease], Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment.”

Indication and limitations

The assay is intended for specialty-care settings as an adjunct to other clinical evaluations; it is not authorized as a population screening tool. The FDA warned that false positives could lead to unnecessary treatments and psychological harm, while false negatives could delay appropriate therapy.

 Physicians must interpret results alongside a full clinical work-up.

Lumipulse was cleared through the 510(k) process as substantially equivalent to the company’s earlier CSF-based β-amyloid ratio test. The new assay also carried FDA Breakthrough Device status, which streamlines reviews for diagnostics addressing life-threatening or irreversibly debilitating condition.

Blood biomarkers have been a key goal for Alzheimer’s diagnostics developers because they could broaden access to early diagnosis, enrollment in clinical trials and timely initiation of disease-modifying therapies. Analysts expect the category to expand as payers look for lower-cost triage tools and as new treatments such as lecanemab and donanemab reach the clinic.

Fujirebio said it will launch the test for use on its Lumipulse G laboratory platform, already installed in major U.S. reference labs. Laboratories must validate the assay before offering it clinically. Pricing and reimbursement details were not disclosed.

For device makers, the clearance underscores the FDA’s willingness to use traditional pathways, supplemented by Breakthrough Device incentives, to speed innovations that fit into existing lab infrastructure and address urgent public-health burdens.

The burden of Alzheimer's disease

An estimated 7.2 million Americans age 65 and older are living with Alzheimer’s dementia in 2025, and when roughly 200,000 younger-onset cases (age 30-64) are included, the national patient pool surpasses 7.4 million, according to the Alzheimer's Association. That equates to about 1 in 9 U.S. seniors (11 percent), with women making up nearly two-thirds of those affected.

Absent disease-modifying breakthroughs, the Alzheimer’s Association projects the U.S. burden will climb to almost 13 million by 2050, underscoring the urgency for earlier detection and effective therapies.

While there is no single, stand-alone test to diagnose Alzheimer’s disease today, including this test, blood testing can be an important piece of the diagnostic process, said Maria C. Carrillo, Ph.D., Alzheimer’s Association chief science officer and medical affairs lead.

“Today marks another important step in Alzheimer’s disease diagnosis,” Carillo said in a news release. “For too long Americans have struggled to get a simple and accurate diagnosis; with today’s action by the FDA we are hopeful it will be easier for more individuals to receive an accurate diagnosis earlier.”

____________________________

About Fujirebio

Fujirebio Diagnostics, Inc. is a cancer diagnostics company and industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, more than 25 years ago. Fujirebio Diagnostics specializes in the clinical development, manufacturing and commercialization of in-vitro diagnostic products for the management of human disease states, with an emphasis in oncology.

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Dear payers: People living with early Alzheimer’s disease are ‘worth it’

In August, on the same day the United Kingdom’s health regulator approved a new treatment for Alzheimer’s disease, the country’s cost-effectiveness regulator recommended nixing national coverage for it.

Since new Alzheimer’s disease treatments are available only to patients in the early stages of the disease, the potential impact on geriatricians, family doctors and other primary care physicians, who are responsible for approximately 85% of initial dementia diagnoses, cannot be overstated. In fact, when the proposed noncoverage policy from the National Institute for Health and Care Excellence (NICE) for the drug, called Leqembi, is finalized this fall, an estimated 70,000 patients living with early Alzheimer’s in the U.K. will be denied access to it.

Good thing that would never happen in the United States to treatments approved by the Food and Drug Administration (FDA) — except that it is, and it’s been going on here for more than a year.

Like in the U.K., the Medicare program and other public and private payers in the United States have set up rationing barriers to Leqembi and a second, newer FDA-approved drug in the same class, called Kisunla.

For more than two years, Medicare has barred coverage unless beneficiaries agree to participate in what the Centers for Medicare & Medicaid Services (CMS) calls coverage with evidence development (CED) for these early Alzheimer’s therapies. Under a CED, Medicare indiscriminately mandates that beneficiaries enroll in clinical studies for coverage of selected treatments, or else coverage will be denied. CMS also imposes strict eligibility criteria on the health professionals and hospitals that can qualify to collect data and run the studies. The net effect is only a small fraction of Medicare beneficiaries get access to FDA-approved treatments subject to CED, with communities of color far too often underrepresented in the required studies.

As my organization detailed in a February 2023 report, Medicare has applied CED over the last 20 years to procedures for severe hearing loss (cochlear implants), less-invasive heart valve replacement, and stem cell transplant for certain cancers and sickle cell disease. The report documents that the CED policy has largely been a failure in yielding meaningful evidence development or expanding timely access. Yet, ignoring the evidence, CMS in April 2022 applied the policy to Alzheimer’s disease medications — the first time Medicare applied CED to an on-label use of an FDA-approved drug. Updated CMS guidance policies released last month indicate it will not be the last.

Other public and private payers have followed CMS’ lead. Despite recent congressional pressure, TRICARE is denying beneficiary access to Leqembi, Kisunla and all future drugs in the same class. TRICARE is the uniformed services health care program for more than 9.5 million active duty and retired service members and their families. Coverage policies from the private insurer, Cigna, call Leqembi and Kisunla “experimental, investigational, or unproven” despite FDA approval and deny coverage for both medications. Several other private payers are using complex guidelines to deter utilization.

Most families contending with Alzheimer’s know that, just like most cancer drugs do not cure cancer, Leqembi and Kisunla do not cure early Alzheimer’s disease. However, like many cancer drugs, clinical trials of these Alzheimer’s therapies have shown effectiveness in delaying disease progression. A recently published study that modeled long-term scenarios found that starting the treatments during the early symptomatic stages of Alzheimer’s disease could delay severe dementia by four to seven months using conservative estimates, and potentially up to two to four years. This is particularly important for people living with early disease, as cognition, personality and ability to care for oneself slowly decline with each passing day.

The risk of side effects related to Leqembi is low, especially compared with almost any cancer drug. Yet, because Alzheimer’s is a deadly disease primarily affecting older adults, it is more likely to be underdiagnosed and undertreated.

Appallingly, we heard one senior CMS official recklessly refer to people living with early Alzheimer’s as “relatively healthy” following the decision to ration access to new treatments. We wonder — would they say the same about someone living with a small, malignant tumor? Probably not.

The annual list price for Leqembi, $26,500, has been slammed in the press. Piling on, CMS officials have wildly overblown cost projections as justification for raising Part B Medicare premiums and increasing Medicare Advantage (MA) provider payments due to the purported cost of Alzheimer’s treatments.

In a summary of its November 2023 call with MA plans, the CMS Office of the Actuary estimated Leqembi costs at $3.5 billion for 2025, jumping an improbable 536% from 2024 ($550 million). That would mean the number of patients receiving the drug would increase from a scant 2,000 beneficiaries at the beginning of 2024 to more than 125,000 patients next year. Yet, at the same time that Medicare has been heavily restricting access to new Alzheimer’s drugs, the program has expanded access to, and increased reimbursement for, $500,000 chimeric antigen receptor (CAR)-T therapies for advanced cancers. Both cancer and Alzheimer’s disease FDA-approved therapies should be equitably covered by Medicare, and neither patient group should be treated as second-class beneficiaries.

Ironically, while the CED process in effect drove manufacturers to lower their list price for the Alzheimer’s drugs, that too ends up hurting Alzheimer’s patients. Both the early Alzheimer’s medications and other complex medications like CAR-T treatments are paid for under Medicare Part B, which pays clinicians 6% of the list price to administer medications. Medicare’s broken payment policies compound the effects of its broken coverage policy, and since Medicare pays providers 6% of the cost of the drug to infuse it, it is more profitable for infusion centers to infuse more expensive drugs. Reports from the field indicate that the combined impact of Medicare’s CED policy and its Part B payment scheme is putting early Alzheimer’s disease patients on waiting lists behind much more lucrative cancer patients.

Ultimately, it is Medicare beneficiaries navigating early Alzheimer’s who will really pay the price, as treatments to delay progression of their disease are finally available but still out of reach due to Medicare’s CED policy. It is time for members of Congress to closely examine CMS’ abuse of CED and oppose any efforts to expand or codify it. This is especially important, considering the recent Supreme Court decision in the case of Loper Bright Enterprises v. Raimondo, which eliminated the deference to which CMS has been previously entitled in its interpretation of the Medicare law. As a result, a coordinated push is being made by others to codify a paradigm that not only isn’t working but is actively harming groups of Medicare beneficiaries.

Payers and cost-effectiveness regulators around the globe are increasingly encroaching on biomedical agency authority, at the expense of patient access. This must stop. If we don’t do something today, we will pay a much bigger societal price tomorrow.

  Dementia Signage for the Home

 

AI tool improves diagnostic accuracy for dementia by 26%

Boston University researchers have developed an artificial intelligence tool designed to assist physicians in diagnosing the specific causes of cognitive decline. The findings were reported in Nature Medicine. While Alzheimer’s disease is the most recognized cause of dementia, it’s not the only one. The diagnostic challenge is compounded by the fact that multiple causes of dementia can occur simultaneously, making it difficult for physicians to arrive at a definitive diagnosis quickly. This delay often hampers timely intervention.

The researchers, led by Vijaya B. Kolachalama, PhD, an expert in using computational tools to aid in medical diagnoses, created an AI-driven platform capable of identifying up to 10 types of dementia, including vascular and frontotemporal dementia. This advanced tool integrates commonly collected patient data—such as medical history, medication use, demographic information, and scores from neurological and neuropsychological exams—with neuroimaging data like MRI scans. The AI then generates a prediction of the type of dementia a patient has, along with a confidence score, offering valuable insights to guide clinical decisions.

“Our goal is for AI to assist in identifying these disorders early, thereby enabling physicians to manage their patients more effectively and potentially prevent the diseases from worsening,” says Kolachalama, who serves as an associate professor of medicine and computer science at BU, in a statement.

The platform’s development represents a collaboration between BU researchers and external experts. Trained on data from over 50,000 individuals across nine global datasets, the AI tool has been rigorously tested, according to the researchers. In a study comparing neurologists working alone to those assisted by the AI, the tool improved diagnostic accuracy by 26%.

This AI tool is particularly valuable because it can function with limited data, which is crucial for health care providers in resource-constrained settings. Kolachalama said that in low-income regions, where MRI machines are less accessible, having a tool that can operate effectively with available clinical data is essential for expanding the reach of this technology.

Kolachalama also notes the increasing strain on health care systems due to a global shortage of neurology experts and a growing number of patients with neurological conditions. By enhancing diagnostic accuracy and efficiency, this AI tool has the potential to significantly alleviate the burden on physicians with limited time and resources.

Looking ahead, Kolachalama said he and his team are focused on bringing this AI platform into hospitals and clinics for real-world testing. The hope is that this technology will soon become an integral part of the diagnostic process, helping to improve outcomes for patients with dementia worldwide.

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Where a patient lives may be the biggest factor for a dementia diagnosis

A University of Michigan study found significant regional differences in the likelihood of receiving a dementia diagnosis in the United States, which could have profound implications for accessing new treatments for Alzheimer's disease and other forms of dementia. The research found that the percentage of people diagnosed with dementia each year varies widely across regions, with particularly stark differences for those aged 66 to 74 and individuals who are Black or Hispanic.

The study, published in Alzheimer's & Dementia: The Journal of the Alzheimer's Association, suggests that where a person lives may play a more significant role in whether they receive a dementia diagnosis than individual risk factors. According to the findings, someone in one region of the U.S. could be twice as likely to be diagnosed with dementia as someone in another region.

Julie Bynum, M.D., a U-M Health geriatrician and lead author of the study, emphasized the need to address these disparities. "These findings go beyond demographic and population-level differences in risk and indicate that there are health system-level differences that could be targeted and remediated," said Bynum in a statement. She noted that the variation in diagnosis rates could be due to differences in health care practices, patient knowledge, and care-seeking behaviors.

The study analyzed data from 4.8 million Medicare beneficiaries aged 66 and older in 2019, focusing on "diagnostic intensity" across 306 hospital referral regions (HRRs). Researchers found that while nearly 7 million Americans currently have a dementia diagnosis, many more likely have symptoms but remain undiagnosed. Access to advanced dementia treatments, including new medications and diagnostic tests, requires a formal diagnosis.

The study found that the prevalence of diagnosed dementia ranged from 4% to 14% across HRRs, with new diagnoses in 2019 ranging from 1.7% to 5.4%. After adjusting for various factors, including education level, smoking rates, obesity, and diabetes, researchers calculated that people in low-intensity areas were 28% less likely to be diagnosed with dementia, while those in high-intensity areas were 36% more likely.

The concentration of dementia diagnoses was highest in the southern U.S., but this pattern shifted once researchers accounted for other risk factors. Bynum suggested that the variation could stem from differences in clinical practices, such as how frequently primary care physicians screen for dementia or the availability of specialists.

Bynum called for increased efforts to ensure early identification of cognitive issues, especially in younger Medicare populations. She also encouraged individuals to advocate for themselves to receive cognitive screenings, which are covered by Medicare during annual wellness visits.

Bynum highlighted Medicare's recent GUIDE model for dementia care as a potential avenue for improving care coordination and access. This new model incentivizes clinical practices to provide better dementia care and offer 24/7 access to trained providers.

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FDA approves new treatment for Alzheimer’s disease

Alzheimer’s disease currently affects more than 6.5 million Americans. The irreversible, progressive brain disorder slowly destroys memory, thinking skills, and overtime, the ability to carry out simple tasks. Even though the specific causes of the disease are not fully known, traits of Alzheimer’s are seen through changes in the brain, including amyloid beta plaques and neurofibrillary. These changes result in the loss of neurons and their connections, affecting a person’s ability to remember, think, and speak.

Recently, the US Food and Drug Administration approved Kisunla (donanemabazbt), an injection for the treatment of Alzheimer’s disease. The organization said the new treatment should be used in patients with mild cognitive impairment or at the mild dementia stage of the disease. Kisunla should also be administered as an intravenous infusion every four weeks.

The efficacy of the treatment was studied in a double-blind, placebo-controlled, parallel-group study in patients with Alzheimer’s disease. Before the start of the study, patients had confirmed presence of amyloid pathology and mild cognitive impairment or mild dementia stage of disease. The study population had a mean age of 73 years, with a range of 59 to 86 years. 57% of patients were female, 91% were White, 6% were Asian, 4% were Hispanic or Latino, and 2% were Black.

For the first three doses, 1,736 patients were randomized 1:1 to receive 700 mg of Kisunla every four weeks and then 1,400 mg every four weeks or placebo for a total of up to 72 weeks. The treatment was switched to placebo based at Weeks 24, 52, and 76 on a prespecified reduction in amyloid levels measured by positron emission tomography (PET).

Patients who were treated with Kisunla showed a significant reduction in clinical decline on the Integrated Alzheimer’s Disease Rating Scale (iADRS), the Alzheimer’s Disease Assessment Scale-Cognitive subscale (ADAS-Cog13), and the Alzheimer’s Disease Cooperative Study – instrumental Activities of Daily Living scale (ADCS-iADL), compared to placebo at Week 76. Patients with Kisunla also demonstrated a significant reduction in clinical decline on the Clinical Dementia Rating Scale, compared to placebo at Week 76.

While Kisunla has been approved, it’s safety information is important to note. When prescribed, the treatment comes with a boxed warning for amyloid-related imaging abnormalities (ARIA). ARIA presents itself as temporary swelling in areas of the brain, usually resolving over time. It also is accompanied by small spots of bleeding in or on the surface of the brain. Typically, ARIA does not have symptoms.

The most common side effects of Kisunla were ARIA and headache. The full prescribing information about Kisunla and its risks can be found here.

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