Latest news with #JoannePike
USA Today
17-05-2025
- Health
- USA Today
FDA clears first blood test to detect Alzheimer's disease. What to know about Lumipulse.
FDA clears first blood test to detect Alzheimer's disease. What to know about Lumipulse. Show Caption Hide Caption Alzheimer's numbers expected to hit 13 million by 2050 Dr. Joanne Pike, CEO of the Alzheimer's Association, talks about the challenges and hopes when it comes to this debilitating disease. We're now closer to being able to diagnose most common form of dementia with a simple test. The Food and Drug Administration on May 16 said it cleared the first blood test for Alzheimer's disease. The blood test is for patients 55 and older who have signs and symptoms of the mind-robbing disease. The Lumipulse blood plasma test detects a disease hallmark, amyloid plaques, which form in the brains of Alzheimer's patients. This approval marks a milestone for patients, their families and doctors, said Howard Fillit, co-founder and chief science officer at the Alzheimer's Drug Discovery Foundation. "The ability to diagnose Alzheimer's earlier with a simple blood test, like we do for cholesterol, is a game changer, allowing more patients to receive treatment options that have the potential to significantly slow or even prevent the disease," Fillit said. The blood test is the first of what researchers say could be a new generation of blood tests to replace expensive brain scans and spinal taps now used to diagnose Alzheimer's, the most common form of dementia. Early diagnosis could allow patients earlier access to FDA-approved drugs to treat Alzheimer's, an incurable disease that afflicts an estimated 7.2 million older Americans. In a statement, FDA Commissioner Martin Makary said 10% of people aged 65 and older have Alzheimer's. "I am hopeful that new medical products such as this one will help patients," Makary said. The Lumipulse blood test is made by Japanese company, Fujirebio Diagnostics, which markets a similar Alzheimer's test that measures cerebrospinal fluid collected by spinal tap. The company did not return messages from USA TODAY asking when the blood test would be available and how much it will cost. The test calculates a ratio of two proteins, tau and amyloid, found in blood plasma. The ratio approximates a measure of whether a patient has amyloid plaques in their brains − a disease hallmark that is now detected by images from expensive PET scans. In clearing the new blood test, the FDA evaluated a clinical study that measured 499 samples from adults who were cognitively impaired. The study measured how often the blood test detected amyloid plaque compared to existing PET scans or spinal fluid tests. The blood test picked up nearly 92% of cases detected by scans or spinal fluid. Less than 20% of cases received an inconclusive result, the FDA said. In a news release, the FDA said the test can "reliably predict the presence or absence of amyloid pathology associated with Alzheimer's disease" in people who are cognitively impaired. The test is meant to be used at memory clinics or other specialized care settings. Risks include possible false positive or false negative results. Alzheimer's researchers believe the disease takes root with brain changes before memory and thinking problems surface. The new generation of blood tests could lead to earlier diagnosis and give patients access to medication. The FDA has approved two Alzheimer's drugs targeting amyloid plaques in adults with early signs of the disease. Eli Lilly's Kisunla and Eisai and Biogen's drug Leqembi include warnings for MRI-visible injuries, which can include brain swelling and tiny bleeds at the surface of the brain.
CBS News
07-04-2025
- Health
- CBS News
How Trump health agency cuts could impact Alzheimer's research and patients
As the Trump administration makes major cuts to federal health agencies , including the National Institutes of Health , some Alzheimer's experts are worried about research for the brain-impairing disease being halted, which could impact treatment options and the lives of patients and their families. The Alzheimer's Association said last week that two related programs have had staff placed on administrative leave as part of the reductions: The Healthy Brain Initiative , which aims to improve understanding around brain health, and Building Our Largest Dementia (BOLD) Infrastructure for Alzheimer's, which focuses on risk reduction as well as increasing detection and diagnosis. These programs "have a meaningful impact on Americans everyday," the organization said in a statement, adding that the BOLD program, as well as other Alzheimer's programs, were just unanimously reauthorized by Congress last year. The association's president and CEO Joanne Pike said these public health programs are critical to those dealing with Alzheimer's and dementia across the country. "Among other things, they ensure that people living with dementia, caregivers and health providers have the information, resources and support they need," Pike said. "The programs remain intact, but continuing on a path of reducing staff and resources could cause irreversible damage." According to the nonprofit Alzheimer's Impact Movement , federal funding for Alzheimer's research accounts for as much as $3.8 billion each year. "Reduced research funding means we are delaying the development and refinement of treatments that could delay or prevent the onset of dementia symptoms, reducing quality of life and increasing suffering for both patients and families," Jason Krellman, a clinical neuropsychologist and assistant professor at Columbia University Irving Medical Center, told CBS News. He says this is a crucial time for brain disease research, as drugs are being developed that show potential to treat the underlying causes of Alzheimer's rather than just slowing its symptoms. "Funding cuts will surely reduce or even stop the progress we are now starting to make toward cures for Alzheimer's disease and related conditions. That is especially problematic because our population is aging more than ever before and these diseases will therefore become much more prevalent in the years to come," he said. Lawrence Chernin, CEO and co-founder of Dabble Health, a company focused on cognitive health monitoring, worries funding cuts could leave potentially life-changing innovations behind. He and his team are developing an app that he hopes could give people a "cognitive score," similar to health apps that give sleep scores — but further testing is needed for scientific validatation. Despite promising data from a pilot study, Chernin said traditional investors often consider tools like theirs "too early and too risky." "Government funding through NIH and SBIR (Small Business Innovation Research) grants represents the only viable bridge from promising research to clinical validation," he told CBS News, adding that his company recently applied for an SBIR grant. "Frankly, without this funding, our company may not survive," he said. "These NIH cuts don't just threaten our company; they threaten the entire pipeline of early-stage medical innovations that could transform Alzheimer's care." SBIR helps fund the NIH's National Institute of Aging, which makes nearly $150 million in grants to small businesses each year. According to the institute, it is the largest source of early-stage funding for aging-related research and development, including interventions for Alzheimer's disease. And while Chernin recognizes some people think there's a lot of waste in government spending, he says "overall it achieves so much," pointing to breakthroughs in cancer research , for example. "Now, cancer isn't as terrible, actually, in terms of the scope of diseases like Alzheimer's is, because there are remedies for cancer," he said. Some, however, like Dr. Joshua Hare, who is chairman and chief science officer at biotechnology company Longeveron , are optimistic. The company just successfully completed a Phase 2 study, published last month in Nature Medicine , for an Alzheimer's medication they've been developing. "Clearly, we have a president who is changing things big-time in all domains of our lives. ... They want to cut funding and streamline the NIH, that's clear, but I'm not at all convinced that they are anti-health," he told CBS News. Hare said he thinks there will be more funding for areas consistent with the Make America Healthy Again initiative, Department of Health and Human Services Secretary Robert F. Kennedy Jr.'s platform focusing on chronic disease, food additives and other priorities. So while there will be cuts to certain areas — COVID and DEI-related initiatives are already being hit , for example — Hare said he's not so worried about Alzheimer's research being slashed. "I can't say that for sure. I'm not in the government. I just listened to the testimony that the new director of NIH gave to Congress in his confirmation hearings, and he specifically addressed Alzheimer's research, and he specifically said that there are avenues of research for Alzheimer's that are underfunded and deserve ongoing funding." His company has previously received NIH funding for a non-Alzheimer's, pediatrics-related trial, while the Alzheimer's Association entirely funded the Phase 1 trial for Longeveron's Alzheimer's drug, Hare said. "If we didn't have that extraordinary funding from Alzheimer's Association and NIH, the company wouldn't have had been able to progress to where we are now." He said company remains "full steam ahead" on getting its product to those who "need it as quickly as possible." While the long-term impacts of the cuts remain unclear, Charles J. Fuschillo, Jr, president and CEO of the Alzheimer's Foundation of America, said in a statement to CBS News that bipartisan cooperation is essential in the continued fight against Alzheimer's disease. "We are grateful that federal policymakers in Congress and the White House worked together in a bipartisan manner over the last decade to deliver essential federal funding increases for Alzheimer's research, and appropriately treated Alzheimer's disease as a growing public health crisis, not a political issue," the statement read. "Building on that progress is vital to ensure we reach the finish line of finding a cure for Alzheimer's."
