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Cision Canada
16 hours ago
- Health
- Cision Canada
FROM THE ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE 2025: ALZHEIMER'S ASSOCIATION RELEASES ITS FIRST CLINICAL PRACTICE GUIDELINE FOR BLOOD-BASED BIOMARKER TESTS
Key Takeaways At AAIC 2025, the Alzheimer's Association released the first in a series of clinical practice guidelines for the diagnosis, treatment and care of Alzheimer's and all other dementia. The guideline focuses on the use of blood-based biomarker tests by specialists to assess levels of Alzheimer's disease pathology in people with cognitive impairment. The Alzheimer's Association provides evidence-based resources to help clinicians identify the disease early and ensure patients receive the right treatment as quickly as possible. These and other planned guidelines are part of ALZPro ™, the Alzheimer's Association's centralized hub for resources, support and information for dementia professionals. TORONTO, July 29, 2025 /CNW/ -- In a landmark step toward transforming Alzheimer's disease diagnosis in specialty care, the Alzheimer's Association today released its first clinical practice guideline (CPG) on the use of blood-based biomarker (BBM) tests. The guideline is being reported at the Alzheimer's Association International Conference ® 2025 (AAIC ®) in Toronto and online, and published in Alzheimer's & Dementia®: The Journal of the Alzheimer's Association. The CPG provides clear evidence-based, brand-agnostic recommendations to support more accurate and accessible diagnosis of Alzheimer's using blood-based biomarker tests. The recommendations are linked to a systematic review using a robust and transparent methodology, and will be updated regularly as evidence evolves. "This is a pivotal moment in Alzheimer's care," said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer and medical affairs lead, and a co-author of the guideline. "For the first time, we have a rigorously evidence-based guideline that empowers clinicians to use blood biomarker tests confidently and consistently. Adoption of these recommendations will lead to quicker, more accessible, more accurate diagnoses — and better outcomes for individuals and families affected by Alzheimer's." The recommendations in the new CPG — both of which apply only to patients with cognitive impairment being seen in specialized care for memory disorders — are: BBM tests with ≥90% sensitivity and ≥75% specificity can be used as a triaging test, in which a negative result rules out Alzheimer's pathology with high probability. A positive result should also be confirmed with another method, such as a cerebral spinal fluid (CSF) or amyloid positron emission tomography (PET) test. BBM tests with ≥90% for both sensitivity and specificity can serve as a substitute for PET amyloid imaging or CSF Alzheimer's biomarker testing. The guideline cautions that there is significant variability in diagnostic test accuracy and many commercially available BBM tests do not meet these thresholds. "Not all BBM tests have been validated to the same standard or tested broadly across patient populations and clinical settings, yet patients and clinicians may assume these tests are interchangeable," said Rebecca M. Edelmayer, Ph.D., Alzheimer's Association vice president of scientific engagement and a co-author of the guideline. "This guideline helps clinicians apply these tools responsibly, avoid overuse or inappropriate use, and ensure that patients have access to the latest scientific advancements." Compared to standard-of-care PET imaging and CSF tests, blood-based biomarkers are typically less costly, more accessible and more acceptable to patients. The guideline emphasizes that BBM tests do not substitute for a comprehensive clinical evaluation by a health care professional, and should be ordered and interpreted by a health care professional in the context of clinical care. This is the first evidence-based guideline using Grading of Recommendations Assessment, Development and Evaluation (GRADE) methodology in the Alzheimer's space. The use of GRADE ensures a transparent, structured and evidence-based process for evaluating the certainty of evidence and formulating recommendations. This strengthens the credibility and reproducibility of the guideline and allows for explicit linkage between evidence and recommendations. This guideline's primary audience includes specialists involved in the diagnostic evaluation of cognitive impairment in specialized care settings. A specialist is defined as a health care provider, typically in neurology, psychiatry or geriatrics, who cares for adults with cognitive impairment or dementia. It also applies to primary care providers, nurse practitioners and physician assistants in specialized care settings. A panel of 11 clinicians convened by the Alzheimer's Association — including clinical neurologists, geriatricians, nurse practitioners, physician assistants and subject-matter experts — conducted a systematic review and formulated evidence-based recommendations for using blood-based biomarkers in individuals with objective cognitive impairment, including those with mild cognitive impairment (MCI) or dementia. Final recommendations were informed by public comments and input from the Association's National Early-Stage Advisory Group, which includes people living with early-stage Alzheimer's. For this initial iteration of the guideline, the BBMs included plasma phosphorylated-tau (p-tau) and amyloid-beta (Aβ) tests measuring the following analytes: p-tau217, ratio of p-tau217 to non-p-tau217 ×100 (%p-tau217), p-tau181, p-tau231, and ratio of Aβ42 to Aβ40. The various BBM tests measure abnormal forms of either amyloid beta or tau protein, the two biomarkers associated with Alzheimer's disease. Forty-nine (49) observational studies were reviewed and 31 BBM tests were evaluated. The panel determined that endorsing specific tests was premature, opting for a brand-agnostic, performance-based approach that blinded panel members to the tests they were evaluating to minimize bias. This ensures the guideline's credibility, durability and actionability. According to the panel: "Ranking or endorsing specific tests is premature at this time. Instead, test accuracy data and accuracy judgments reported in this guideline are meant to serve as a resource for clinicians … to aid them in choosing which test(s) to order." The panel formulated two recommendations and one Good Practice Statement for the use of BBM tests in the diagnostic workup of patients with objective cognitive impairment being seen in specialized care. Recommendation 1 — In patients with objective cognitive impairment presenting for specialized memory-care, the panel suggests using a high-sensitivity BBM test as a triaging test in the diagnostic workup of Alzheimer's disease. Recommendation 2 — In patients with objective cognitive impairment presenting for specialized memory care, the panel suggests using a high-sensitivity and high-specificity BBM test as a confirmatory test in the diagnostic workup of Alzheimer's disease. Good Practice Statement — A BBM test should not be obtained before a comprehensive clinical evaluation by a health care professional, and test results should always be interpreted within the clinical context. The panel urges clinicians to consider the pre-test probability of Alzheimer's disease pathology for each patient when deciding whether or not to use a BBM test. This CPG is part of ALZPro ™, the Alzheimer's Association's comprehensive hub of resources to promote best practices, empowering health professionals across disciplines to reduce risk, advance early detection, improve care and expand equitable access for all communities. ALZPro unites care resources, relevant scientific findings, clinical guidelines and insights, continuing education and implementation tools on one platform. Upcoming clinical practice guidelines will address cognitive assessment tools (Fall 2025), clinical implementation of staging criteria and treatment (2026) and prevention of Alzheimer's and other dementias (2027). This clinical practice guideline was convened and funded by the Alzheimer's Association, but the Association was not involved in formulating the clinical questions or recommendations. About the Alzheimer's Association International Conference ® (AAIC ®) The Alzheimer's Association International Conference (AAIC) is the world's largest gathering of researchers from around the world focused on Alzheimer's and other dementias. As a part of the Alzheimer's Association's research program, AAIC serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community. AAIC 2025 home page: AAIC 2025 newsroom: AAIC 2025 hashtag: #AAIC25 About the Alzheimer's Association ® The Alzheimer's Association is a worldwide voluntary health organization dedicated to Alzheimer's care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia ®. Visit or call 800.272.3900. Session: Evidence-Based Clinical Practice Guidelines for Detection and Diagnosis of Cognitive Impairment using Blood-based Biomarkers and Cognitive Testing: Two Guideline Initiatives from the Alzheimer's Association Proposal ID: 108894 Oral Presentation: Tuesday, July 29, 2025: 2:00 P.M.-3:30 P.M. EDT (3-21-DEV) Clinical practice guideline for blood-based biomarkers in the diagnostic workup of Alzheimer's disease within specialized care settings: A report from the Alzheimer's Association Background: In recent years, blood-based biomarkers (BBMs) have transformed the diagnostic landscape of Alzheimer's disease (AD), with some now approaching readiness for clinical implementation. This progress aligns with the growing importance of accurate early diagnostics and availability of anti-Aβ therapies for the treatment of early symptomatic AD, reinforcing the need for more rapid and early diagnostic capabilities. To address this need, the Alzheimer's Association convened a multidisciplinary panel of clinical experts, subject-matter specialists, and guideline methodologists to conduct a systematic review and develop evidence-based recommendations for the use of BBMs in the diagnostic evaluation of AD. The scope of this guideline is focused on individuals with cognitive impairment - either MCI or dementia - who are undergoing diagnostic assessment in secondary or tertiary care settings. Method: The panel conducted a systematic review to assess BBMs' diagnostic test accuracy in detecting amyloid pathology for triaging (≥90% sensitivity, ≥75% specificity) and confirmatory (≥90% sensitivity and specificity) diagnostic workup. The BBMs of interest included plasma p-tau and Aβ tests measuring the following analytes: p-tau217, %p-tau217, p-tau181, p-tau231, and Aβ42/Aβ40 ratio. The reference standard tests included CSF, amyloid PET, or neuropathology examination. The panel applied the GRADE approach to assess the certainty of the evidence and the GRADE Evidence-to-Decision Framework to develop its recommendations. Result: Across 49 observational studies meeting eligibility criteria, 31 different BBM tests were evaluated. Using predefined decision thresholds, the panel determined whether each test has 1) sufficient diagnostic test accuracy to be used as a triaging test where a positive test is to be confirmed by PET or CSF, 2) sufficient diagnostic test accuracy as a confirmatory test to replace PET or CSF, or 3) insufficient diagnostic test accuracy to recommend current use in clinical practice. Recommendations will be provided in case any BBMs met a priori DTA thresholds. Conclusion: BBMs can improve early AD diagnosis and expand access to disease-modifying therapies. Evidence-based guidelines are key to standardizing their use and will be updated as new evidence and applications emerge. SOURCE Alzheimer's Association
Yahoo
2 days ago
- Health
- Yahoo
Neurogen Biomarking Virtual Care Ecosystem Cuts Time to Alzheimer's Intervention by 4.5 Years, AAIC 2025 Presentation Findings Show
Elisabeth Thijssen Progress in validating in-home blood test, combined with cognitive assessment and specialty virtual care, break through barriers to early detection Key Takeaways Findings from breakthrough approach to early detection for Alzheimer's disease (AD) has the potential to reduce time from earliest development of symptoms to care by 4.5 years are presented at the AAIC 2025. Results show strong correlation between TASSO vs. traditional phlebotomist blood draw/capillary collection with the potential to successfully triage patients. New ecosystem brings together in-home biomarker testing and a cognitive assessment with virtual care to reduce multiple barriers to the early detection and treatment of Alzheimer's disease. Neurogen's online platform offering in-home blood testing for Alzheimer's disease for people with memory concerns is in beta test and readies for national launch – offers a potential solution to meet the urgent global demand for faster adoption and equitable access to breakthrough testing technologies for early detection of AD. CHICAGO, July 28, 2025 (GLOBE NEWSWIRE) -- Advancements in accelerating early Alzheimer's disease screening and access to care proven from three diverse community pilot initiatives were presented today during a podium presentation at the Alzheimer's Association International Conference® 2025 (AAIC). The study entitled, 'Remote Collection of Biomarkers for Alzheimer's Disease and Related Disorders' was designed to validate Neurogen's new ecosystem that brings together the first in-home biomarker testing and a cognitive assessment with virtual care. Study findings suggest that the ecosystem has the potential to reduce the time from earliest development of symptoms to care by 4.5 years breaking down multiple barriers to early detection and treatment of Alzheimer's disease. The study also validated a strong correlation between TASSO vs. traditional phlebotomist blood draw/capillary collection suggesting TASSO's potential to successfully triage patients. 'We created a new model to reach those with Mild Cognitive Impairment (MCI),' said Elisabeth Thijssen, PhD, Chief Scientific Officer, Neurogen Biomarking and the session presenter whose research focus for nearly a decade has been on blood-based biomarkers for AD and specifically P-tau217. 'Neurogen's ecosystem is built to meet the urgent global demand for faster adoption of breakthrough testing technologies for early detection of AD. Our mission is to give everyone equal access to cutting-edge technology to detect Alzheimer's early—when treatment can make the greatest impact on the course of people's lives.' The findings come from three free community events targeting people aged 50 years and older held at local hospitals in Chicago, Illinois; Flint, Michigan; and Coldwater, Michigan to sign up participants. Participants were recruited through community engagement, traditional and social media and mobilization of communications targeting area health and wellness organizations. About the Screenings Event participants began the screening with an advanced digital cognitive assessment and a brief lifestyle survey. Every participant did the traditional IV venous blood draw performed by a licensed professional. The TASSO, non-invasive method that allows for blood collection without the need for a needle was offered and optional. All samples were preserved through ambient shipment, maintaining integrity without the need for refrigeration or freezing. IV samples were analyzed using the ALZpath P-tau217 assay, a validated ultrasensitive biomarker test that closely correlates with Alzheimer's pathology. Testing was conducted in CLIA- and CAP-certified laboratories, ensuring clinical accuracy and regulatory compliance with results within days and a follow up via telehealth counseling with a board-certified neurologist if needed. Study Results A total of 455 participants received biomarker and digital cognitive testing: 66% were Women Average age was 67 45% were White/Caucasian 39% were Black/African American 16% did not report Among the 455 test participants, 26 percent had elevated P-tau217 concentrations Eighty percent had some form of cognitive impairment as is typical in this kind of event TASSO could identify elevated P-tau217 with 88% accuracy and meets the performance requirement for AD triaging in a broader population. Participants with elevated test results received follow up care via telehealth from board certified neurologists within days. The Neurogen ecosystem reduced the time from cognitive concerns to intervention by 4.5 years—changing the standard time from the emergence of cognitive concerns from years (3 to 6 years) to months (4 months to 1.5 years). 'In one-day events held in three different U.S. communities reaching people with no prior dementia diagnosis, we found 18 percent tested positive for P-tau217 and an additional eight percent were intermediate,' Dr. Thijssen stated. 'Bringing these people immediately into virtual care with a neurologist who shared the test results and provided a personalized brain health action care plan was heartening given the long wait time to see a specialist once a patient expresses memory concerns to their primary care physicians that is now typical in the US.' Neurogen's online ecosystem offers in-home testing for Alzheimer's disease for people with memory concerns and virtual follow up care with board-certified neurologists. It is now in beta test and readies for national launch. The Unmet Need: Access to Early Detection Testing for Alzheimer's An estimated 40% of Americans aged 65 and older—representing more than 16 million people—experience some form of memory impairment¹. Yet, fewer than 8% of older adults living with Mild Cognitive Impairment (MCI) ever receive a formal diagnosis, leaving 92% without answers or access to early intervention². On average, there is a staggering 6- to 8-year delay from the onset of symptoms to diagnosis—even though today's treatments are most effective when administered in the earliest stages of disease3. Further compounding the issue, fewer than one in five Alzheimer's diagnoses in the U.S. currently involve biomarker testing, due in large part to gaps in accessibility and clinical expertise³. These data underscore an urgent call to transform how Alzheimer's and cognitive decline are detected and managed—especially as the aging population grows and new diagnostic tools become available. About Neurogen Neurogen Biomarking is on a global mission to give everyone equitable access to brain health care. The company offers the first at-home blood biomarker test for phosphorylated (P-tau217) using proprietary blood collection technology and advanced digital cognitive testing with results guided by board-certified neurologists via telehealth. Neurogen's vision is to deliver accessible technology, actionable insights, and pathways to precision-based proactive care to support early detection and care for Mild Cognitive Impairment (MCI) and dementia associated with Alzheimer's disease (AD). Neurogen was founded by award-winning neurologist Dr. Rany Aburashed and developed with co-founders Elisabeth Thijssen, PhD, Chief Scientific Officer, and Ken Bahk, Chief Strategy Officer. The company is guided by a team of world-renowned brain health experts Media Contacts:Reilly Connect for Neurogen - 3696 Citations Small, G.W. (2002). What we need to know about age-related memory loss. BMJ, 324(7352), 1502–1505. Liu, J. L., Hlavka, J. P., Coulter, D., Baxi, S. M., & Mattke, S. (2023).Barriers to the Use of Alzheimer's Disease Biomarkers in Clinical Practice. Alzheimer's & Dementia: Diagnosis, Assessment & Disease Monitoring, 15(1), Alzheimer's Association. (2023). 2023 Alzheimer's Disease Facts and Figures. Alzheimer's & Dementia, 19(3), 159–258. A photo accompanying this announcement is available at in to access your portfolio
Associated Press
3 days ago
- Health
- Associated Press
FROM THE ALZHEIMER'S ASSOCIATION INTERNATIONAL CONFERENCE 2025: DECADES-OLD LEAD POLLUTION LINKED TO MEMORY PROBLEMS IN OLDER ADULTS, STUDY FINDS
Key Takeaways TORONTO, July 27, 2025 /PRNewswire/ -- Historic lead levels from the era of leaded gasoline may be contributing to cognitive issues 50 years later, suggests research reported for the first time at the Alzheimer's Association International Conference ® 2025 (AAIC®), in Toronto and online. Americans are about 20% more likely to experience memory problems if they lived in areas with high levels of atmospheric lead between 1960 and 1974, according to the analysis of more than 600,000 adults 65 and older. ' Research suggests half the U.S. population — more than 170 million people — were exposed to high lead levels in early childhood. This research sheds more light on the toxicity of lead related to brain health in older adults today,' said Maria C. Carrillo, Ph.D., Alzheimer's Association chief science officer and medical affairs lead. 'Other studies reported at AAIC 2025 suggest that (a) lead exposure at any point in life may cause cognitive problems, (b) it may be more likely to affect certain populations and reflect disparities, and (c) there is a biological connection between lead exposure and Alzheimer's.' Historic levels of lead air pollution are associated with memory problems 50 years later In a first-of-its-kind study, researchers examined how exposure to airborne lead from 1960-1974 — when leaded gasoline use was at its highest — may affect brain health later in life. They determined that older adults who grew up in areas with moderate to extremely high historical atmospheric lead levels (HALL) were about 20% more likely to report memory problems as adults 50 years later. The researchers calculated the average HALL by area and linked it to self-reported memory problems from the American Community Survey from 2012-2017 (368,208 people) and 2018-2021 (276,476 people). They didn't analyze the source of the lead but believe that the higher the density of automobile traffic, such as in urban areas, the higher the atmospheric lead. Factoring in both time periods, the researchers determined that 17-22% of people living in areas with moderate, high or extremely high atmospheric lead reported memory issues. 'Our study may help us understand the pathways that contribute to some people developing dementia and Alzheimer's disease,' said Eric Brown, M.D., MSc, FRCPC, lead author of the study, associate scientist and associate chief of geriatric psychiatry at the Centre for Addiction and Mental Health, Toronto. Lead was originally added to gasoline to increase performance until researchers determined it posed serious risks to health and the environment. The more than 20-year-long phase-out of leaded gas began in 1975 when all new cars sold in the U.S. were required to have catalytic converters. 'When I was a child in 1976, our blood carried 15 times more lead than children's blood today,' said Esme Fuller-Thomson, Ph.D., senior author of the study and a professor at the University of Toronto's Factor-Ientash Faculty of Social Work and director of the Institute for Life Course and Aging. 'An astonishing 88% of us had levels higher than 10 micrograms per deciliter, which are now considered dangerously high.' While the risk of atmospheric lead has decreased, other sources of exposure remain, such as old lead paint and pipes. Those who have been exposed to atmospheric lead should focus on reducing other risk factors for dementia, including high blood pressure, smoking and social isolation, said Brown. Living near lead-polluting sites may affect memory Another study reported at AAIC found that older adults who live about three miles from a lead-releasing facility — such as glass, ready-mixed concrete or computer and electronics manufacturers — are more likely to have memory and thinking problems than those who live farther away. This research, which focused on a racially and ethnically diverse group of older adults, reinforces concerns about the long-term cognitive impact of environmental lead exposure, especially in communities already facing health disparities. Researchers assessed 2,379 patients (average age ~74 years) from two studies: the Kaiser Health Aging and Diverse Life Experienced study (KHANDLE, 1,638 patients) of a diverse group of Kaiser Permanente insurance plan members who live in northern California, and the Study of Healthy Aging in African Americans (STAR, 741 patients) study of Black adults age 50 and older who live in the San Francisco and Sacramento areas. They evaluated the participants' proximity to the nearest lead-releasing facility and compared the distance to participants' Neuropsychological Assessment Scales results at baseline and two years later. Compared to two years earlier, the KHANDLE participants who lived within 5 km (just over three miles) of a lead-releasing facility scored 0.15 times lower on verbal episodic memory tests (recall of personal experiences), and 0.07 times lower on overall cognitive ability compared to those living farther away. Every 5 km farther a participant lived from a lead-releasing facility was associated with 5% higher memory scores two years later. Among STAR group participants living within 5 km of a lead-releasing facility, researchers observed a 0.20 times lower score on semantic memory (general knowledge) two years later, compared to those who lived farther away. 'Our results indicate that lead exposure in adulthood could contribute to worse cognitive performance within a few years,' said Kathryn Conlon, Ph.D., MPH, senior author and associate professor of environmental epidemiology, School of Medicine, University of California, Davis. 'Despite tremendous progress on lead abatement, studies have shown there is no safe level of exposure, and half of U.S. children have detectable levels of lead in their blood. Additionally, there are regions and neighborhoods that have more exposure.' According to Conlon, there were 7,507 lead-releasing facilities in the U.S. in 2023. To reduce exposure, Conlon said people living near lead-producing facilities should keep their homes clean to avoid the accumulation of lead-contaminated dust, remove their shoes when coming inside, and place dust mats inside and outside to avoid tracking lead-contaminated dust indoors. Use the Environmental Protection Agency's TRI Toxics Tracker to identify lead-releasing facilities near you. Study reveals how lead exposure may set the stage for Alzheimer's Even low levels of lead exposure can create permanent changes in brain cells, including increased buildup of abnormal tau and amyloid beta, which are proteins associated with Alzheimer's, suggests a third study reported at AAIC 2025. The researchers exposed human brain cells to lead concentrations of zero, 15 and 50 parts per billion (ppb), simulating the kind of lead exposure people might experience through contaminated water or air. The EPA's action level for lead in drinking water is 15 ppb. They ran molecular, genetic, biochemical and functional tests on the cells and determined that (a) the 15-ppb and 50-ppb lead-exposed neurons were more electrically active (suggesting early dysfunction) than those that had no exposure, (b) energy-producing cells were damaged, and (c) there was an increase in tau and amyloid beta. Even after the lead was removed, the cells remained primed for damage, responding more severely to additional stressors such as tau. 'These findings help explain how lead exposure, especially in early life or from occupational and environmental sources, might leave a lasting molecular imprint on the brain making it more vulnerable to age-related diseases like Alzheimer's,' said Junkai Xie, Ph.D., lead author of the study and post-doctoral research associate in chemical engineering at Purdue University. 'Our results show that lead exposure isn't just a short-term concern; it may set the stage for cognitive problems decades later.' About the Alzheimer's Association International Conference® (AAIC®) The Alzheimer's Association International Conference (AAIC) is the world's largest gathering of researchers from around the world focused on Alzheimer's and other dementias. As a part of the Alzheimer's Association's research program, AAIC serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community. AAIC 2025 home page: AAIC 2025 newsroom: AAIC 2025 hashtag: #AAIC25 About the Alzheimer's Association® The Alzheimer's Association is a worldwide voluntary health organization dedicated to Alzheimer's care, support and research. Our mission is to lead the way to end Alzheimer's and all other dementia — by accelerating global research, driving risk reduction and early detection, and maximizing quality care and support. Our vision is a world without Alzheimer's and all other dementia®. Visit or call 800.272.3900. View original content to download multimedia: SOURCE Alzheimer's Association
