FDA OKs first blood test that can help diagnose Alzheimer's disease
WASHINGTON (AP) — U.S. health officials on Friday endorsed the first blood test that can help diagnose Alzheimer's and identify patients who may benefit from drugs that can modestly slow the memory-destroying disease.
The test can aid doctors in determining whether a patient's memory problems are due to Alzheimer's or a number of other medical conditions that can cause cognitive difficulties. The Food and Drug Administration cleared it for patients 55 and older who are showing early signs of the disease.
More than 6 million people in the United States and millions more around the world have Alzheimer's, the most common form of dementia.
The new test, from Fujirebio Diagnostics, Inc., identifies a sticky brain plaque, known as beta-amyloid, that is a key marker for Alzheimer's. Previously, the only FDA-approved methods for detecting amyloid were invasive tests of spinal fluid or expensive PET scans.
The lower costs and convenience of a blood test could also help expand use of two new drugs, Leqembi and Kisunla, which have been shown to slightly slow the progression of Alzheimer's by clearing amyloid from the brain. Doctors are required to test patients for the plaque before prescribing the drugs, which require regular IV infusions.
'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,' said Dr. Michelle Tarver, of FDA's center for devices.
A number of specialty hospitals and laboratories have already developed their own in-house tests for amyloid in recent years. But those tests aren't reviewed by the FDA and generally aren't covered by insurance. Doctors have also had little data to judge which tests are reliable and accurate, leading to an unregulated marketplace that some have called a 'wild west.'
The tests can only be ordered by a doctor and aren't intended for people who don't yet have any symptoms.
___
AP Medical Writer Lauran Neergaard contributed to this story
___
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
The Hill
an hour ago
- The Hill
How thousands of unreviewed ingredients got into our food — and what FDA can do about it
At least 1,000 ingredients in food products on our grocery store shelves have never been checked for safety by the Food and Drug Administration. Dozens have raised serious safety concerns among experts. How did the FDA allow this? The answer can be found in the agency's lax interpretation of a little-known legal designation that lets companies decide for themselves if ingredients in their products are safe. Fortunately, there are steps the agency can take right now to stem the flow of potentially unsafe ingredients into our food supply. Environmental Defense Fund outlined these steps in a letter we recently sent to the agency, but first let's take a closer look at how we got here. 'Generally Recognized as Safe' is a designation Congress created in 1958 to allow commonly used food ingredients to bypass the FDA's pre-market safety review process. It was meant for food substances — such as oils, vinegar, baking soda and common spices — that were widely considered safe due to their long history of everyday use. Since 1958, this status has been coopted to cover a universe of foods that extends far beyond its original intent. According to FDA regulations, a chemical can receive the designation if experts widely agree that scientific evidence shows its use to be safe. But because 'Generally Recognized as Safe' wasn't meant for newer ingredients, Congress allowed ingredients so designated to skip the FDA's premarket approval process — despite requiring similar evidence for other additives. Under the agency's current interpretation, companies can designate the use of a substance as safe and take products with that substance to market without informing the FDA or the public of its decision. While companies may voluntarily submit a notice to FDA offering safety evidence, they are not required to — and often don't. Our organization estimated that manufacturers have notified FDA of fewer than half of the ingredients they market as safe under the 'Generally Recognized' standard. Companies that do bother to submit a notice to the FDA are free to withdraw it at any point and take their product to market, provided they can cite evidence of its safe use. But this 'evidence' is often far from independent. Companies can, and often do, enlist their own employees or handpicked consultants to conduct their safety assessments. The result is a process riddled with conflicts of interest that lets unsafe foods into Americans' homes. We analyzed 'Generally Recognized as Safe' notices received by the FDA, obtained via a Freedom of Information request, and found that of the 1,163 submitted by companies between 1997 and April 2024, 192 were later withdrawn, with safety concerns cited in at least a dozen cases. We also identified 31 ingredients that companies have advertised to be recognized as safe, such as in press releases, trade publications and on their own websites (see the Appendix of our letter). However, we were unable to find the scientific evidence required under this standard to demonstrate these ingredients are commonly regarded as safe among experts. This raises red flags that FDA should be taking seriously. Although a comprehensive fix to the 'Generally Recognized' standard will require legislation from Congress, there are significant steps the FDA can take right away to ensure a more rigorous determination process that better protects Americans' health. Starting today, the FDA can use existing authority to remove safe designations from ingredients it deems unsafe and take them off the market. It can also notify manufacturers, importers, distributors and retailers that the substance is no longer recognized as safe. In addition, the FDA can enforce the requirement that companies base safety designations on publicly available data. Although this won't curtail companies' ability to self-declare substances as safe, it will require those who do to be transparent in citing their evidence. Third, the FDA can enforce the requirement that safety assessments consider vital health information such as a substance's dietary sources, potential cancer risks and the cumulative health effects of similar substances. Finally, the FDA can make companies revise and resubmit their data for review when they submit 'Generally Recognized as Safe' notices that fail to comply with the criteria. The 'Generally Recognized as Safe' designation is far from a perfect system, but it can work better if it is interpreted and enforced more comprehensively. If the FDA is serious about protecting public health, it should start by fully exercising the tools already at its disposal. Maria Doa is senior director at the Chemicals Policy at Environmental Defense Fund. Maricel Maffini is an independent consultant focused on human and environmental health and chemical safety.
Yahoo
an hour ago
- Yahoo
Psychedelics as potential mental health treatment are explored by Trump administration
The Trump administration has expressed interest in exploring psychedelics for their potential in treating PTSD and other debilitating mental health issues, various officials have shared. "The Department shares the goal of ensuring that all Americans — especially our nation's veterans — have access to safe and effective treatments for conditions such as PTSD, addiction and depression," a spokesperson for the U.S. Department of Health and Human Services (HHS), run by Sec. Robert J. Kennedy Jr., said in a statement provided to Fox News Digital. "Secretary Kennedy is committed to applying rigorous, evidence-based science to research efforts aimed at addressing these serious health challenges." Fda Approves First Ai Tool To Predict Breast Cancer Risk In recent years, researchers have been actively investigating the potential of psychedelics, such as MDMA and psilocybin ("magic mushrooms") to treat mental health disorders. MDMA is not approved for clinical use by the U.S. Food and Drug Administration (FDA), but can be studied in clinical settings. Read On The Fox News App Psilocybin is listed as a Schedule I substance under the Controlled Substances Act, which means it has "a high potential for abuse, [is not] currently accepted for medical use in treatment in the United States, and [has] a lack of accepted safety for use under medical supervision." Psilocybin-assisted therapy, however, is legal in Oregon, Colorado and New Mexico. Psychedelic medicines are "showing real promise," according to Dr. Luke Twelves, general practitioner and vice president of medical for Lindus Health in London. Clinical trials have found such treatments safe and effective for patients battling serious mental health issues, according to Twelves. Common Supplements And Medications Could Cause Liver Damage, Studies Show "Take psilocybin, for example — it's demonstrating remarkable results for severe depression that hasn't responded to other medications," he told Fox News Digital. "MDMA is showing similar breakthroughs for PTSD treatment." Clinical trials are also investigating how psychedelics could help with end-of-life anxiety, addiction, eating disorders, chronic pain and OCD, he added. Researchers have faced challenges in terms of regulatory hurdles and proper placebo controls, Twelves said. "Given that these treatments could transform [the] lives of people suffering from conditions where nothing else has worked effectively, it's crucial that we complete this research properly," he said. "The goal is to bring safe, proven psychedelic therapies to the patients who need them most." At President Trump's May 1 cabinet meeting, Department of Veterans Affairs Secretary Doug Collins said that "we're opening up the possibility of psychedelic treatment." Retired Army Sergeant Jonathan Lubecki recently told Fox News' Alexandria Hoff that MDMA stopped his PTSD while he was participating in a clinical trial. "[I] took my first dose of MDMA. I've only taken it three times as part of the clinical trial, haven't taken it since, and haven't found the need to take it since, because I haven't had PTSD," he said. Peter Kasperowicz, Department of Veterans Affairs press secretary, told Fox News Digital the department is safely exploring all avenues that promote the health of veterans. Fallujah Vet Turns Medal Of Heroism Into A Healing Mission For Fellow Warriors With Service Dogs Program "Preliminary findings have produced positive results on psychedelic-assisted therapies for treating mental health conditions," he said. The VA is currently running 11 clinical trials in various phases, with a total of some 800 veterans expected to participate. "The goal of these trials is to determine whether compounds such as MDMA and psilocybin can treat veterans with post-traumatic stress disorder, treatment-resistant depressive disorder, major depressive disorder and potentially other mental health conditions," said Kasperowicz. An MDMA study published in the Jan. 2025 issue of The American Journal of Psychiatry found that the substance is "unlike classical psychedelics." The study noted, "MDMA allows the individual to maintain intact ego functioning and a greater degree of cognitive and perceptual lucidity while still experiencing a prosocial altered state of consciousness that facilitates deeply emotional therapeutic breakthroughs." Click Here To Sign Up For Our Health Newsletter The researchers concluded that MDMA showed "enhanced levels of trust, empathy, self-compassion and a 'window of tolerance'" that traditional psychotherapy lacks. Doug Drysdale, CEO of the Canadian pharmaceutical company Cybin, told Fox News Digital that "the time is now to address the mental health crisis." He said it is "gratifying" that administration officials value the potential benefits of looking into alternative mental health treatments. Cybin is currently in phase 3 of a study of CYB003, a type of psilocybin that has been granted breakthrough therapy designation by the FDA as an additional treatment for major depressive disorder (MDD). "In Cybin's completed Phase 2 MDD study, long-term efficacy results showed that 71% of participants were in remission from depression, and 100% of participants responded to treatment at 12 months after just two 16 mg doses of CYB003," said Drysdale. Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and Fox News' senior medical analyst, previously interviewed two of the country's top researchers on psychedelics — Dr. Rachel Yehuda, founder and director of the Center for Psychedelic Psychotherapy and Trauma Research at Mt. Sinai in New York, and Dr. Charles Marmar, director of the PTSD research program at NYU Langone. "They agree there is therapeutic potential if very carefully studied under very strict medical guidance, but there is a huge downside in terms of unregulated recreational uses," Siegel told Fox News Digital at the time. "Both doctors see likely therapeutic value to psychedelics if carefully managed by medical experts," Siegel added. Ryan Moss, chief science officer at Filament Health, a clinical-stage natural psychedelic drug development company in Canada, emphasized it's important to administer psychedelics in a safe setting when treating mental health conditions. For more Health articles, visit "Psychedelic experiences can sometimes feature anxiety, hallucinations and paranoia," Moss previously told Fox News Digital. "Some patients using traditional psychedelics have reported experiencing adverse cardiovascular events during clinical trials." To mitigate these risks, Moss recommended clinical trial participants receive thorough preparation and monitoring by trained professionals during sessions. Melissa Rudy and Angelica Stabile, both of Fox News Digital, contributed article source: Psychedelics as potential mental health treatment are explored by Trump administration
Time Business News
an hour ago
- Time Business News
Comprehensive Senior Memory Support Services for Dementia Care
As we age, cognitive decline becomes a genuine concern for many families. Caring for loved ones with dementia or Alzheimer's disease can be overwhelming. Fortunately, senior memory support services are here to provide the necessary support. These services are tailored to meet the unique needs of seniors and ensure they receive the compassionate and dignified care they deserve. Let's explore how these services can provide you with the care you need. Senior memory support services include different programs and resources that help older adults with memory problems. These services range from special memory care homes for people with dementia to help provided in their own homes. They offer full support to meet different needs. More than 50 million people around the world have dementia, and that number is growing. This shows the importance of having strong support systems in place. Memory support can take different forms, depending on the level of care required. Here are some common types of services: These are special living places for seniors with dementia. Staff are available all day and night to help with daily needs. They also offer planned activities that keep residents engaged and active. Caregivers come to the senior's home to help with daily tasks. This support allows the person to remain in a familiar space. It helps them feel more independent while remaining safe. These programs give seniors a chance to take part in group activities during the day. They often include games, music, and light exercise. At the same time, caregivers get a break from full-time care. Respite care gives short-term help when the main caregiver needs time off. It can take place at home or in a care center. During this time, trained staff care for seniors to keep them safe and comfortable. A key part of good memory care for seniors is making it personal. Each person with dementia has a different experience, so their care should match their needs. Personalized memory care for dementia focuses on the person's past, likes, and daily habits. Utilizing familiar activities and surroundings helps seniors feel more comfortable and enhances their well-being. Choosing the right memory care for a loved one requires careful consideration. First, think about how much help they need. Do they need care all the time, or can they still do some things on their own? Then, look at different care options. Visit the places, talk to the staff, and read reviews. Ensure that the setting is safe and supports your loved one in staying active and social. The main goal of memory care is to help seniors with dementia live with dignity and enjoy a better quality of life. It's important to give kind, ongoing care as families face these hard times. Choosing personal care now can help build a strong support system, giving your loved one the best chance to do well. If you are looking for support, check out the programs in your area. Taking action today can help your loved one have a brighter and more fulfilling future. Is this article helpful? Keep reading our blog for more. TIME BUSINESS NEWS
