Latest news with #AlzheimersDisease
Yahoo
24-05-2025
- Health
- Yahoo
Opinion - The NIH delivers a major victory for animal ethics in science
The National Institutes of Health recently announced a landmark initiative to expand human-based science while reducing animal use. The world's largest funder of biomedical and public health research will now prioritize innovative health research, leaving outdated animal experiments behind. The announcement highlights the scientific limitations of translating findings from animals to humans. Paired with growing crises of illnesses such as Alzheimer's disease, cancer and heart disease, these limitations stagnate medical advances. NIH investment in research to better understand and treat disease is crucial for improving the health of Americans. As Director Jay Bhattacharya points out, by expanding human-based research, this initiative will usher in a new era of innovation, improve health care outcomes and deliver life-changing treatments. Methods like tissue chips, organoids and bioprinting are already being used to replace animals and improve clinical translation, including in disease modeling, precision medicine and regulatory toxicology. These methods use human cells, tissue and data to replicate human-specific biology and disease traits and have enormous potential to revolutionize medical research and testing. A 2022 economic analysis estimated that the use of more predictive, preclinical non-animal technologies instead of animal tests could generate over $24 billion in increased research productivity, resulting in streamlined drug development and potential cost savings for patients. Indeed, this is the rationale for the Food and Drug Administration's new plan to phase out animal testing requirements for monoclonal antibodies and other drugs. Historically, billions of dollars — as much as half of the NIH's budget for research — has been spent every year on animal experiments that do not translate well to human clinical outcomes. This research results in the harming and killing of millions of animals annually, diverts funds from more effective human-based approaches, delays medical breakthroughs that patients desperately need and puts clinical-trial participants at risk of adverse effects that were not detected in poorly predictive preclinical animal tests. The NIH will now take the necessary steps to overcome these barriers. The NIH has made steady progress toward the development and use of non-animal research approaches. In 2024, the agency accepted comprehensive recommendations on catalyzing non-animal approaches made by an advisory group. In conjunction, a new program called Complement-ARIE was launched that aimed to speed up the development, standardization, validation and use of such methods. The new announcement builds on this progress in a major way, establishing a new office to coordinate NIH-wide efforts to improve the use of non-animal approaches and committing to expand funding, training, and infrastructure for human-based science. The initiative also addresses review-related barriers to the broader use of non-animal methods. Our team leads an international collaboration aimed at characterizing and mitigating a phenomenon called animal methods bias, in which peer reviewers of grant applications or scientific studies prefer animal-based methods or lack the expertise necessary to adequately review non-animal methods. Consequently, researchers who use non-animal methods can receive unfair review comments, sometimes resulting in the rejection of funding or publishing submissions. The new NIH initiative will implement funding evaluation criteria to help improve review quality and ensure impartiality toward different methods. It will also provide bias mitigation training to review staff and integrate non-animal expertise in review groups. These are all measures our team has been advocating for. The initiative establishes another provision that will be crucial for public trust: public reporting of animal- and non-animal-based spending. Over the years, snapshots of the funding landscape have rarely been made available. In 2012, an NIH staff member estimated that 47 percent of NIH-funded grants had an animal research component. A 2016 blog post (removed but still available on the web archive) indicated that about 47 percent of extramural research project grants used mice and that mouse use was trending upward. A 2023 advisory committee presentation indicated an upward trend in NIH-funded research using non-animal alternatives, landing at about 8 percent in 2021. Regular, clear funding data will help the agency stay accountable to the initiative's goals. While an improvement over 10 or 20 years ago, NIH investment in non-animal alternatives still pales in comparison to its bankrolling of animal research. Much work remains to overcome the stronghold animal experiments have on biomedical research, upheld by centuries of tradition, the research animal trade and methods bias. Bhattacharya's announcement indicates the NIH is ready to tackle these crucial issues. Another recent agency announcement promotes the importance of supporting a diversity of ideas in science 'in the edge cases where scientists are pursuing evidence that others find inconvenient or objectionable.' Unraveling our reliance on animal experiments will require embracing fresh perspectives and disrupting the status quo, and the NIH is now prioritizing this work. The new initiative to prioritize human-based science is necessary, and it will have profound impacts on human health. Catharine E. Krebs, PhD, is a medical research program manager with the Physicians Committee for Responsible Medicine. Elizabeth Baker, JD, is the director of research policy with the Physicians Committee. Copyright 2025 Nexstar Media, Inc. All rights reserved. This material may not be published, broadcast, rewritten, or redistributed.
Medscape
23-05-2025
- Health
- Medscape
Cold Sore Virus Implicated in Alzheimer's Disease
Herpes simplex virus 1 (HSV-1) infection is associated with an increased risk of developing Alzheimer's disease (AD), but treating the viral infection may offer protection, a new study found. In a matched case-control study of nearly 700,000 older adults, HSV-1 was more common in those with AD, and antiviral therapy for HSV-1 was associated with a lower risk of developing AD. However, the authors and outside experts cautioned that no firm conclusions can be drawn from this observational study and called for more research. The study was published online on May 20 in BMJ Open . It was funded by Gilead Sciences, which is actively involved in the research and development of treatments for HSV. Mixed Data HSV-1, a common virus that causes cold sores, affects more than two thirds of the global population younger than 50 years. An association between HSV-1 and AD has been reported previously, albeit with conflicting results across various studies. One recent Taiwanese cohort study found that symptomatic HSV infection was associated with a threefold increased risk of developing dementia. Antiherpetic medication reduced the risk by 90%. However, a study of US veterans failed to link HSV infection with an increased risk for dementia. Although, like the Taiwanese findings, antiherpetic medication was associated with a protective effect against dementia. To investigate further, researchers led by Yunhao Liu, PhD, data scientist with Gilead Sciences, used the IQVIA PharMetrics Plus claims database to match 344,628 people with AD to an equal number of control individuals without AD. Compared with 823 (0.24%) control individuals without an AD diagnosis, 1507 (0.44%) individuals diagnosed with AD had a history of HSV-1. Among those with AD, nearly two thirds were women (65%), their mean age was 73 years, and they tended to have more coexisting conditions. After adjusting for relevant confounding factors, the likelihood of an HSV-1 diagnosis was 80% higher in those with AD (adjusted odds ratio [aOR], 1.80; 95% CI, 1.65-1.96). In a stratified analysis, the association of HSV-1 with AD was more pronounced in older age groups — with an aOR of 2.10 in those aged 75 years or older vs an aOR of 1.14 in those aged 50-70 years. 'These findings are consistent with studies suggesting that the neurodegenerative impact of HSV-1 becomes more apparent with age and cumulative exposures,' the authors noted. Among the 2330 adults with a history of HSV-1, 931 (40%) were treated with antiherpetic medication, which was associated with a 17% reduced risk for AD compared with no treatment (adjusted hazard ratio [aHR], 0.83; 95% CI, 0.74-0.92). 'While the molecular mechanisms remain to be fully elucidated, these results are indicative of a possible role for antiherpetic therapy in mitigating dementia risk,' the authors wrote. Caveats and Cautionary Notes F. Perry Wilson, MD, Yale School of Medicine, New Haven, Connecticut, and Medscape's Impact Factor commentator, noted in a recent commentary that studies that use administrative data have limitations and said the author's suggestion that antiherpetic therapies are potentially protective for AD-related dementia 'feels like a bit of a leap to me at this point.' On the other hand, Wilson said, 'for those who suffer from cold sores, a study like this may push you a bit toward treatment, at least during an outbreak. Short-term valacyclovir is relatively safe and reduces the duration of the cold sore by about a day, which is nice. But if it reduces your risk of dementia as well, well, it might be a no-brainer.' Several outside experts also weighed in on the study in a statement from the UK nonprofit Science Media Centre. Sheona Scales, PhD, director of research at Alzheimer's Research UK, Cambridge, England, cautioned that 'despite the large sample size, this research has limitations partly due to only using health records and administrative claims data.' 'Most people infected with HSV-1 don't have any symptoms, so some infections might not have been recorded. Infections predating the information recorded are also not available. Although cases were matched with controls, diagnosing Alzheimer's disease, especially in the early stages, remains a challenge,' Scales commented. While the study found that some people receiving medicines to treat HSV-1 infections had a lower risk for AD, 'a lot more work is needed to unpick this,' she added. 'We know there are 14 established risk factors for dementia, and there's not enough evidence to include infections in this list. This study doesn't tell us if infections are causing the risk, it only shows an association. Further research is needed to understand what the underlying biology around this is,' Scales said. Tara Spires-Jones, PhD, director of the Centre for Discovery Brain Sciences at The University of Edinburgh, Edinburgh, Scotland, said the study adds to a growing body of data linking HSV-1 and other viral infections to the risk for AD. However, 'it is important to note that HSV-1 infection, which is extremely common in the population, is by no means a guarantee that someone will develop Alzheimer's,' Spires-Jones noted. 'Why viral infections may increase risk of dementia is not fully understood, but the most likely explanation is that infections increase inflammation in the body and contribute to age-related brain inflammation. More research is needed to understand the best way to protect our brains from Alzheimer's disease as we age, including a better understanding of links between viral infection and Alzheimer's risk,' Spires-Jones said. Richard Oakley, PhD, director of Research and Innovation at Alzheimer's Society, London, England, cautioned that the study 'doesn't prove that cold sores cause Alzheimer's disease, or that antivirals prevent it. Much more research is needed to explore exactly how viruses might be involved and before we can draw firm conclusions.'
Yahoo
17-05-2025
- Health
- Yahoo
Fujirebio Receives Marketing Clearance for Lumipulse® G pTau 217/ β-Amyloid 1-42 Plasma Ratio In-vitro Diagnostic Test as an Aid to Identify Patients With Amyloid Pathology Associated With Alzheimer's Disease
—First Blood-Based In-Vitro Diagnostic Test to Receive FDA Clearance for Patients Being Assessed for Alzheimer's Disease. — —Availability of Accurate, Accessible, Blood-Based Diagnostic Tests Will Aid in Development and Availability of More Effective Interventions for Alzheimer's Disease — MALVERN, Pa., & TOKYO, May 17, 2025--(BUSINESS WIRE)--Fujirebio today announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the company's Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test for the assessment of amyloid pathology in patients being evaluated for Alzheimer's disease and other causes of cognitive decline. The test, which was granted Breakthrough Device Designation by the FDA, is the first FDA cleared blood-based IVD test in the U.S. to aid to identify patients with amyloid pathology associated with Alzheimer's Disease (AD). Alzheimer's disease currently affects an estimated 7.2 million Americans, a number projected to rise to nearly 14 million by 2060.1 It is a leading cause of disability and death. AD develops over many years, long before symptoms are evident, but the lack of accessible, minimally invasive diagnostics results in many patients remaining undiagnosed until the disease is well advanced, when few effective interventions remain. The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio test is an accurate, minimally invasive, accessible measurement of pTau 217 and β-Amyloid 1-42 concentrations in plasma as a proxy for the presence of β-Amyloid plaque pathology in the brain. It is intended for use in adult patients aged 50 years and older presenting at a specialized care setting with signs and symptoms of cognitive decline. In a clinical study population of 499 patients, which closely mirrored the US demographics, and when applying a dual cut point, the test demonstrated a positive predicate value (PPV) of 92%, a negative predicate value (NPV) of 97% with only 20% patients who are uncertain to have amyloid pathology, thus requiring further testing. The Lumipulse pTau 217/ β-Amyloid 1-42 Plasma Ratio test uses Fujirebio's fully automated LUMIPULSE® G1200 instrument system, which is widely available in clinical laboratories throughout the U.S. The new ratio test complements the Lumipulse G β-Amyloid Ratio (1-42/1-40), authorized by the FDA for use in CSF in May 2022. "The lack of effective, accessible and minimally invasive diagnostics for AD contributes to its late diagnosis and inadequate treatment," says Monte Wiltse, President and CEO at Fujirebio Diagnostics, Inc. "The Lumipulse G pTau 217/ β-Amyloid 1-42 Plasma Ratio test will go a long way to assist physicians and patients to obtain an AD diagnosis in early stages of the disease, when interventions are more effective. As part of our worldwide commitment to improve the diagnosis and treatment of AD, Fujirebio is developing additional assays, which will increase the availability of diagnostic tools and expand the foundation for early, more effective treatment." About Fujirebio Fujirebio, a member of H.U. Group Holdings Inc., is a global leader in the field of high-quality in vitro diagnostics (IVD) testing. It has more than 50 years' accumulated experience in the conception, development, production and worldwide commercialization of robust IVD products. Fujirebio was the first company to develop and market CSF biomarkers under the Innogenetics brand over 25 years ago. Fujirebio offers a comprehensive line-up of manual and fully automated assays for neurological diseases and consistently partners with organizations and clinical experts across the world to develop new pathways for earlier, easier and more complete neurodegenerative diagnostic tools. More information can be found at About Fujirebio Diagnostics, Inc. Fujirebio Diagnostics, Inc., a wholly-owned subsidiary of Fujirebio Holdings, Inc., is the premier cancer diagnostics company and the industry leader in cancer biomarker assays. The company pioneered and introduced the CA125 test, the first FDA-approved ovarian cancer biomarker, over 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. For more information about Fujirebio Diagnostics, please call +1 610-240-3800 or visit us at Reference 1. (2025), 2025 Alzheimer's disease facts and figures. Alzheimer's Dement., 21: e70235. View source version on Contacts MEDIA CONTACT: Chris DagueFujirebio Diagnostics, 484-395-5556daguec@ Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
20-02-2025
- Entertainment
- Yahoo
Dave Matthews' mom Valerie dead at 89 after Alzheimer's battle
Dave Matthews is in mourning. The singer-songwriter's mother, Valerie Anne Matthews, has died after a battle with Alzheimer's disease. She was 89. Valerie passed away on Sunday, Feb. 9, at her home in Charlottesville, Virginia, according to her online obituary published Tuesday. 'Val's children, grandchildren, and great-grandchild were able to gather around her in the days leading up to her death,' the obituary revealed. 'It was a time of great sadness but also one of joy, filled with laughter and music and stories. Val's kindness, graciousness and humor shone through to the end. Her family will always treasure this time together.' Dave and his brother, Peter, along with his sister, Jane, were at their mother's bedside when she died, TMZ reported on Wednesday. The outlet added that Valerie was placed in hospice care after her health rapidly declined earlier this year due to 'natural causes.' The sudden change led Matthews to drop out of the FireAid benefit concert just a day before it took place in Los Angeles on Jan. 30. In a Jan. 29 announcement posted on the Dave Matthews Band's Instagram, the group cited 'a critical illness in the family' as the reason for the cancellation. Born on May 11, 1935, in Potchefstroom, South Africa, to a geologist and an artist, Valerie went on to earn a degree in architecture at the University of Witwatersrand in Johannesburg. In 1961, Val, as she was known to her friends, married John Matthews, and together they moved to Charlottesville with their children — Dave, Peter, Anne and Jane — after his work brought him to the University of Virginia. They were married for 15 years before John passed away from Hodgkin's lymphoma at the age of 45. In 1994, Valerie faced another devastating loss when her daughter Anne, 29, was tragically killed by her husband, who later took his own life, leaving behind their two young children. 'Although devastated by Anne's death, Val stepped into the breach, gaining custody of her grandchildren and bringing them back to Charlottesville, where they were embraced by extended family,' her obit read. 'Val did not allow tragedy or grief to define her. She rejoiced in family and friends, and delighted in simple pleasures.' The announcement continued, 'In the final years of her life, Val was cared for in her home by a devoted team of caregivers. Val's family will be forever grateful to this remarkable group of women for their selflessness, diligence, humor, and love, and for the grace and dignity they afforded Val as she battled Alzheimers Disease.' Valerie was employed at the firm Hayward, Llorens, and Boyd until her retirement in 1994. She had a deep appreciation for nature, poetry, and watercolor painting, as noted in her obituary. 'Val was a passionate advocate for peace, environmental conservation, marriage equality, and women's rights, never afraid to use her voice,' her obituary stated. 'She spoke out against racism, bigotry, and small-mindedness through social activism and frequent letters to the editor.' Valerie is survived by Dave and his wife Ashley, son Peter and his wife Kathleen, daughter Jane and her husband Sam, six grandchildren and one great-grandson, Freddie. She was predeceased by her first husband John, daughter Ashley and her second husband, Lee Strait, who died in 2000 after a stroke. Valerie and Strait married in 1991.
