Health
Experimental Alzheimer’s drug gets FDA advisory panel's thumbs-up: ‘Progress is happening’
An experimental Alzheimer’s drug, donanemab, was endorsed by a U.S. Food and Drug Administration (FDA) advisory panel on Monday.
Donanemab is designed to treat symptoms of early Alzheimer’s disease, including mild cognitive impairment and mild Alzheimer’s dementia.
At the FDA’s Peripheral and Central Nervous System Advisory Committee hearing, which was held in Maryland on Monday, the advisers unanimously agreed that the drug’s benefits outweigh any potential risks.
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While this isn’t a guarantee the FDA will approve the drug, the agency does typically follow the panel’s recommendations, per reports.
“The FDA held the advisory committee meeting to hear the viewpoints and assessments of the experts on both the benefits and the risks of donanemab,” the agency told Fox News Digital in an emailed statement.
“As with all applications the FDA receives, we will thoroughly review and consider the input from the committee.”
An experimental Alzheimer’s drug, donanemab, was endorsed by a U.S. Food and Drug Administration advisory panel on Monday. (iStock)
Officials at Eli Lilly, the Indiana pharmaceutical company that makes donanemab, were also in attendance, fielding questions from the committee about potential side effects.
At the Monday hearing, Eli Lilly officials presented clinical trial results that showed the drug slowed cognitive and functional decline for people with mild cognitive impairment due to early stages of Alzheimer’s.
The study was also published by the Journal of the American Medical Association.
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In phase 3 trials published in May 2023, donanemab was shown to “significantly slow cognitive and functional decline in people with early symptomatic Alzheimer’s disease,” according to a press release on Eli Lilly’s website.
If donanemab is approved, it would become only the second available medication designed to slow the progression of Alzheimer’s symptoms.
Donanemab is designed to treat symptoms of early Alzheimer’s disease, including mild cognitive impairment and mild Alzheimer’s dementia. (iStock)
Leqembi, the first new Alzheimer’s treatment in 20 years, was given full FDA approval in July 2023.
Donanemab works by clearing built-up amyloid from the brain. It was shown to cause side effects such as “brain swelling and tiny bleeds,” researchers found.
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The Alzheimer’s Association, based in Chicago, released a statement welcoming the FDA’s finding that donanemab is effective for the treatment of early Alzheimer’s disease.
“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs,” said Joanne Pike, DrPH, Alzheimer’s Association president and CEO, in a statement provided to Fox News Digital.
Eli Lilly officials presented clinical trial results showing that the drug, donanemab, slowed cognitive and functional decline for people with mild cognitive impairment due to early stages of Alzheimer’s. (iStock)
“Progress with treatment is happening. Now we need more types of treatments, targeting a variety of aspects of the disease, with greater efficacy and safety,” she continued.
“A rich and robust life without the threat of memory loss, confusion or cognitive decline — this is what we envision.”
The next step toward approval of donanemab is FDA review.
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center, noted that donanemab is very similar to Leqembi, the current drug on the market that blocks amyloid formation. (Dr. Marc Siegel)
Dr. Marc Siegel, clinical professor of medicine at NYU Langone Medical Center and a Fox News medical contributor, who was not involved in the drug trials, noted that donanemab is very similar to Leqembi, the current drug on the market that blocks amyloid formation.
“A rich and robust life without the threat of memory loss, confusion or cognitive decline — this is what we envision.”
“The problem with … denonemab is similar — it can cause brain swelling and bleeding,” Siegel told Fox News Digital.
“It is also expensive, as it’s once a month versus once every two weeks for Leqembi.”
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Denonemab is “somewhat more effective,” Siegel noted, as it slows progression of Alzheimer’s by about 35% versus 27% for Leqembi.
“It may be better at removing plaques,” he said.
“A future with more approved Alzheimer’s treatments is a tremendous advancement for people eligible for these drugs,” the Alzheimer’s Association president and CEO said in a statement. (iStock)
There may be limitations associated with these types of drugs, however, according to the doctor.
“Many experts have told me that the obsession with amyloid formation may not be the holy grail it was once thought to be,” Siegel told Fox News Digital.
“The study didn’t pay enough attention to tau proteins, which are also a key player here.”
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Tau proteins, which cause “tangles” in the brain of Alzheimer’s patients, are not the primary targets of these drugs, Siegel said.
“There is also the issue of neuroinflammation and neuronal transmission abnormalities, which precede the buildup of the plaque proteins and are important targets for research.”
In response, Eli Lilly provided the below statement.
“Lilly is pursuing multiple approaches to treat Alzheimer’s disease and other forms of dementia. Our pipeline of molecules in human testing includes ones aimed at amyloid (donanemab, remternetug), tau (OGA inhibitor), as well as lewy body dementia and frontotemporal dementia.”
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Health
Lurking dementia risk exposed by breakthrough test 25 years before symptoms
Study finds link between obesity and vascular dementia
Fox News senior medical analyst Dr. Marc Siegel joins ‘America’s Newsroom’ to discuss an increase in colon cancer in people under 50 despite an overall lowering cancer deaths and a new study linking obesity to vascular dementia.
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A new blood test could determine a woman’s dementia risk as early as 25 years before symptoms emerge.
That’s according to new research from the University of California San Diego, which found that a specific biomarker protein associated with early pathological processes of Alzheimer’s disease was “strongly linked” to future dementia risk.
The researchers analyzed blood samples from 2,766 participants in the Women’s Health Initiative Memory Study in the late 1990s, according to the study’s press release.
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The women ranged from 65 to 79 years of age and showed no signs of cognitive decline at the start of the study.
After tracking the participants for up to 25 years, the researchers concluded that the biomarker phosphorylated tau 217 (p-tau217) was “strongly associated” with future mild cognitive impairment and dementia.
A new blood test could determine a woman’s dementia risk as early as 25 years before symptoms emerge. (iStock)
Women who had higher levels of p-tau217 at the beginning of the study were “much more likely” to develop the disease. The findings were published today in JAMA Network Open.
“The key takeaway is that our study suggests it may be possible to detect risk of dementia two decades in advance using a simple blood test in older women,” first author Aladdin H. Shadyab, a UC San Diego associate professor of public health and medicine, told Fox News Digital.
“These biomarkers may help us identify who is at greatest risk and develop strategies to delay or prevent dementia.”
“Our findings show that the blood biomarker p-tau217 could help identify individuals at higher risk for dementia long before symptoms begin,” he added.
This long lead time could open the door to earlier prevention strategies and more targeted monitoring, rather than waiting until memory problems are already affecting daily life, according to Shadyab.
A specific biomarker protein associated with early pathological processes of Alzheimer’s disease was “strongly linked” to future dementia risk. (iStock)
“As the research advances, these biomarkers may help us identify who is at greatest risk and develop strategies to delay or prevent dementia,” he said.
This risk relationship wasn’t the same across the board, however. Women over 70 with higher p-tau217 levels had “poorer cognitive outcomes” compared to those under 70, as did those with the APOE ε4 gene, which is a known risk factor for Alzheimer’s disease.
The study also found that p-tau217 was a stronger predictor of dementia in women who were randomly assigned to receive estrogen and progestin hormone therapy compared to those who received a placebo.
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“Blood-based biomarkers like p-tau217 are especially promising because they are far less invasive and potentially more accessible than brain imaging or spinal fluid tests,” said senior author Linda K. McEvoy, senior investigator at Kaiser Permanente Washington Health Research Institute and professor emeritus at the Herbert Wertheim School of Public Health, in the release.
“Blood-based biomarkers like p-tau217 are especially promising because they are far less invasive and potentially more accessible than brain imaging or spinal fluid tests,” a researcher said. (iStock)
“This is important for accelerating research into the factors that affect the risk of dementia and for evaluating strategies that may reduce risk.”
Blood tests for Alzheimer’s disease are still being studied and are not recommended for routine screening in people without symptoms, Shadyab noted.
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More research is needed before this approach can be considered for clinical use prior to cognitive symptoms.
Future studies should investigate how other factors — like genetics, hormone therapy and age-related medical conditions — might interact with plasma p-tau217, the researchers added.
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“The study examined only older women, so the findings may not necessarily apply to men or younger populations,” Shadyab noted. “We also examined overall dementia outcomes rather than specific subtypes such as Alzheimer’s disease.”
Health
Key fitness measure is strong predictor of longevity after certain age, study finds
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For women over 60, muscle strength plays a critical role in longevity, a new study confirms.
Researchers at the University at Buffalo, New York, followed more than 5,000 women between the ages of 63 and 99, finding that those with greater muscle strength had a significantly lower risk of death over an eight-year period.
The findings were published in JAMA Network Open.
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Muscle function was measured using grip strength and how quickly participants could complete five unassisted sit-to-stand chair raises.
These are two tests commonly used in clinical settings to evaluate muscle function in older adults, the researchers noted.
A recent study shows that stronger muscle strength in women over 60 is linked to a lower risk of death over eight years. (iStock)
“In a community cohort of ambulatory older women, muscular strength was associated with significantly lower mortality rates, even when we accounted for usual physical activity and sedentary time measured using a wearable monitor, gait speed and blood C-reactive protein levels,” study lead author Michael LaMonte, research professor of epidemiology and environmental health at the University at Buffalo, told Fox News Digital.
“Movement is the key — just move more and sit less.”
Many earlier studies did not include those objective measurements, making it difficult to determine whether muscle strength itself was linked to longevity, according to LaMonte. “Our study was able to better isolate the association between strength and death in later life,” he added.
Even for women who don’t get the recommended amount of aerobic physical activity, which is at least 150 minutes per week, muscle strength remained important for longevity, the researchers found.
Women with greater muscle strength were more likely to live longer, even if they did not meet the recommended amount of aerobic exercise. (iStock)
“The findings of lower mortality in those who had higher strength but were not meeting current national guidelines on aerobic activity were somewhat intriguing,” LaMonte said.
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Federal guidelines recommend strengthening activities one to two days per week, targeting major muscle groups.
Resistance training does not have to require a gym membership, LaMonte noted. These exercises can be performed using free weights, resistance bands, bodyweight movements or even household items, such as soup cans.
Experts recommend working major muscle groups one or two days a week using weights, bands or bodyweight exercises. (iStock)
“Movement is the key — just move more and sit less,” he said. “When we can no longer get out of the chair and move around, we are in trouble.”
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LaMonte acknowledged several limitations of the study. The researchers assessed muscle strength in older age but did not explore how earlier levels in adulthood might influence long-term health outcomes.
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“We were not able to understand how strength and mortality relate in younger ages,” he said, noting that future research should explore whether building strength earlier could have an even greater impact on longevity.
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