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Experimental Alzheimer’s drug gets FDA advisory panel's thumbs-up: ‘Progress is happening’

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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.

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“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.

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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)

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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. 

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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)

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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.”

— Joanne Pike, CEO of the Alzheimer’s Association

“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. 

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“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.”              

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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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Melissa Joan Hart, 49, Opens up About Weight Loss in Perimenopause

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Melissa Joan Hart, 49, Opens up About Weight Loss in Perimenopause


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Alzheimer’s prevention breakthrough found in decades-old seizure drug

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Alzheimer’s prevention breakthrough found in decades-old seizure drug

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A drug that has long been used to treat seizures has shown promise as a potential means of Alzheimer’s prevention, a new study suggests.

The anti-seizure medication, levetiracetam, was first approved by the FDA in November 1999 under the brand name Keppra as a therapy for partial-onset seizures in adults. The approval has since expanded to include children and other types of seizures.

Northwestern University researchers recently found that levetiracetam prevented the formation of toxic amyloid beta peptides, which are small protein fragments in the brain that are commonly seen in Alzheimer’s patients.

The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons, according to the study findings, which were published in Science Translational Medicine.

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The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease.

The medication was found to prevent the formation of amyloid-beta 42 in both animal models and cultured human neurons. (iStock)

“While many of the Alzheimer’s drugs currently on the market, such as lecanemab and donanemab, are approved to clear existing amyloid plaques, we’ve identified this mechanism that prevents the production of the amyloid‑beta 42 peptides and amyloid plaques,” said corresponding author Jeffrey Savas, associate professor of behavioral neurology at Northwestern University Feinberg School of Medicine, in a press release. 

“Our new results uncovered new biology while also opening doors for new drug targets.”

HIDDEN BRAIN CONDITION MAY QUADRUPLE DEMENTIA RISK IN OLDER ADULTS, STUDY SUGGESTS

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The brain is better able to avoid the pathway that produces toxic amyloid‑beta 42 proteins in younger years, but the aging process gradually weakens that ability, Savas noted. 

“This is not a statement of disease; this is just a part of aging. But in brains developing Alzheimer’s, too many neurons go astray, and that’s when you get amyloid-beta 42 production,” he said. 

The effect was also seen in post-mortem human brain tissue obtained from individuals with Down syndrome, who are at high risk for Alzheimer’s disease. (iStock)

That then leads to tau (“tangles”) — abnormal clumps of protein inside brain neurons — which can kill brain cells, trigger neuroinflammation and lead to dementia.

In order for levetiracetam to function as an Alzheimer’s blocker, high-risk patients would have to start taking it “very, very early,” Savas said — up to 20 years before elevated amyloid-beta 42 levels would be detected.

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“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death,” the researcher noted.

The researchers also did a deep dive into previous human clinical data to determine whether Alzheimer’s patients who were taking the anti-seizure drug had slower cognitive decline. They reported that the patients in that category had a “significant delay” in the span from cognitive decline to death compared to those not taking the drug.

“This analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” the researcher said. (iStock)

“Although the magnitude of change was small (on the scale of a few years), this analysis supports the positive effect of levetiracetam to slow the progression of Alzheimer’s pathology,” Savas said.

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Looking ahead, the research team aims to find people who have genetic forms of Alzheimer’s to participate in testing, Savas said.

Limitations and caveats

The study had several limitations, including that it relied on animal models and cultured cells, with no human trials conducted.

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Because the study was observational in nature, it can’t prove that the medication caused the prevention of the toxic brain proteins, the researchers acknowledged.

Savas noted that levetiracetam “is not perfect,” cautioning that it breaks down in the body very quickly.

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The team is currently working to create a “better version” that would last longer in the body and “better target the mechanism that prevents the production of the plaques.”

“You couldn’t take this when you already have dementia, because the brain has already undergone a number of irreversible changes and a lot of cell death.”

The medication’s common documented side effects include drowsiness, weakness, dizziness, irritability, headache, loss of appetite and nasal congestion.

It has also been linked to potential mood and behavior changes, including anxiety, depression, agitation and aggression, according to the prescribing information. In rare cases, it could lead to severe allergic reactions, skin reactions, blood disorders and suicidal ideation.

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Funding for the study was provided by the National Institutes of Health and the Cure Alzheimer’s Fund.

Fox News Digital reached out to the drug manufacturer and the researchers for comment.

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Seniors over 80 who eat specific diet may be less likely to reach 100 years old

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Seniors over 80 who eat specific diet may be less likely to reach 100 years old

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Older adults who avoid meat in their golden years may be less likely to reach age 100 than their meat-eating counterparts, new research suggests.

Researchers tracked more than 5,000 adults aged 80 or older who were enrolled in the Chinese Longitudinal Healthy Longevity Survey.

Between 1998 and 2018, data showed that those who did not eat meat were less likely to reach their 100th birthday than those who consumed animal products regularly.

The findings seem to contradict previous studies that have linked vegetarianism and plant-based diets to lower risks of heart disease, stroke, diabetes and obesity.

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Most evidence supporting the benefits of plant-based diets comes from studies tracking younger populations, the researchers noted. 

The findings contrast with previous research praising plant-based diets for their positive influence on heart health. (iStock)

The study, published in The American Journal of Clinical Nutrition, points to losses in muscle mass and bone density with age, shifts that can increase the risk of malnutrition and frailty in the “oldest old.”

As people enter their 80s and 90s, the nutritional priority often shifts from preventing long-term chronic diseases to maintaining day-to-day physical function, experts say.

HOW MUCH RED MEAT IS TOO MUCH? EXPERTS WEIGH IN ON FOOD PYRAMID UPDATES

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“The headline ‘vegetarians over 80 less likely to reach 100’ sounds surprising, because it contrasts with decades of data linking plant‑forward diets to lower chronic disease risk earlier in life,” Erin Palinski-Wade, a New Jersey-based registered dietitian, told Fox News Digital. 

“However, once you see that this research is limited to adults over the age of 80 who are also underweight — and that this link disappears with the consumption of eggs, dairy and fish — the results are less surprising.”

While diets earlier in life tend to emphasize avoiding long-term disease, older age necessitates nutrients and weight maintenance, experts say. (iStock)

In those over 80, restricting animal proteins may be less likely to promote longevity, according to Palinski-Wade, who was not involved in the study.

Eliminating all animal protein — particularly in a population that may already experience diminished hunger cues — can make it more difficult to meet adequate protein needs, potentially increasing the risk of nutrient deficiencies, the nutritionist said.

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In addition to a higher tendency to be underweight, older populations also face a greater risk of bone fractures due to lower calcium and protein intake.

Potential limitations

The lower rate of vegetarians reaching 100 was only observed in participants identified as underweight, the researchers noted. No such association was found in people who maintained a healthy weight.

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Because being underweight is already linked to greater frailty and mortality risk, the researchers noted that body weight may partly explain the findings, making it difficult to determine whether diet itself played a direct role.

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Those incorporating animal-sourced products other than meat were just as likely to live to 100. (iStock)

Additionally, the shortened lifespans were not found in people who continued to eat non-meat animal products, such as fish, dairy and eggs. 

Older adults with these more flexible diets were just as likely to live to 100 as those eating meat, as these foods may provide the nutrients necessary for maintaining muscle and bone health, the researchers noted.

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“This is an observational study, so it can only show associations, and does not prove that avoiding meat directly reduces the odds of reaching 100,” Palinski-Wade added.

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The researchers suggested that including small amounts of animal-sourced foods could help older seniors maintain essential nutrients and avoid the muscle loss often seen in those who stick strictly to plants.

Eliminating all animal protein — particularly in a population that may already experience diminished hunger cues — can make it more difficult to meet adequate protein needs, potentially increasing the risk of nutrient deficiencies. (iStock)

Palinski-Wade offered some guidance for those looking to optimize nutrition later in life.

“For adults in their 80s and beyond, especially anyone losing weight or muscle, the priority should be maintaining a healthy weight and meeting protein and micronutrient needs — even if that means adding or increasing fish, eggs, dairy or well‑planned, fortified plant proteins and supplements.”

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Strict vegan or very low‑protein patterns at that age should be carefully monitored by a dietitian or clinician, with attention to B12, vitamin D, calcium and total protein, according to Palinski-Wade.

“Younger and healthier adults can still confidently use plant‑forward or vegetarian patterns to lower long‑term chronic disease risk,” she added.

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