FDA approves Alzheimer’s drug Leqembi, paving way for broader Medicare coverage

The Food and Drug Administration on Thursday fully approved the Alzheimer’s treatment Leqembi, a pivotal decision that will expand access to the expensive drug for older Americans.

Medicare announced shortly after the FDA approval that it is now covering the antibody treatment for patients enrolled in the insurance program for seniors, though several conditions apply.

Leqembi is the first Alzheimer’s antibody treatment to receive full FDA approval. It is also the first such drug to receive broad coverage through Medicare.

Leqembi is not a cure. The treatment slowed cognitive decline from early Alzheimer’s disease by 27% over 18 months during Eisai’s clinical trial. The antibody, administered twice monthly through intravenous infusion, targets a protein called amyloid that is associated with Alzheimer’s disease.

Medicare coverage is a crucial step to help older Americans with early Alzheimer’s disease pay for the treatment. With a median income of about $30,000, most people on Medicare cannot afford the $26,500 annual price of Leqembi set by Eisai without insurance coverage.

Medicare had previously only agreed to cover Leqembi for patients participating in clinical trials after the treatment received expedited approval in January. This policy had severely restricted access to the drug.

To be eligible for coverage, patients must be enrolled in Medicare, diagnosed with mild cognitive impairment or mild Alzheimer’s disease, and have a doctor who is participating in a data-collection system the federal government has established to monitor the treatment’s benefits and risks.

Joanna Pike, president of the Alzheimer’s Association, the lobby group that advocates on behalf of people living with the disease, said although Leqembi is not a cure, it will help patients in the early stages of the disease maintain their independence, conduct their daily lives, and spend more time with their families.

“This gives people more months of recognizing their spouse, children and grandchildren,” Pike said in a statement Thursday. “This also means more time for a person to drive safely, accurately and promptly take care of family finances, and participate fully in hobbies and interests.”

But the treatment carries serious risks of brain swelling and bleeding. Three patients who participated in Eisai’s study died. FDA scientists have said it is unclear if Leqembi played a role in these deaths.

Alzheimer’s disease is the most common cause of dementia among older adults and the sixth leading cause of death in the U.S., according to the FDA.

Dr. David Knopman, a neurologist who specializes in Alzheimer’s disease at the Mayo Clinic in Minnesota, said Leqembi clearly demonstrated a benefit to patients in Eisai’s trial, though he cautioned the efficacy of the treatment was modest.

Knopman said appropriately diagnosed and informed patients should be able to decide for themselves whether they want to take Leqembi after weighing the benefits and risks of the treatment as well as the potential logistical challenges of finding a place to receive the twice-monthly infusions.

Medicare coverage

To receive coverage, Medicare is requiring patients to find a health-care provider participating in a registry system that collects real-world data on the drug’s benefits and risks. The system is controversial. The Alzheimer’s Association and some members of Congress are worried this requirement will create barriers to treatment.

There are concerns that the number of health-care providers participating in such registries will be limited, and that people in rural towns and other underserved communities will have to travel long hours to find such a provider.

The Centers for Medicare and Medicaid Services has set up a nationwide portal to make it easy for health-care providers to submit the required data on patients receiving Leqembi. The free-to-use portal went live moments after the FDA decision on Thursday.

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Rep. Anna Eshoo of California, the ranking Democrat on the House Subcommittee on Health, and Rep. Nanette Barragan, D-Calif., raised concerns in a letter to CMS last month that patients could struggle to find a doctor participating in the system.

Alzheimer’s is typically diagnosed with the help of a PET scan to detect the amyloid protein associated with the disease or in some cases with a spinal tap. Medicare currently only covers one PET scan per lifetime for dementia. It is unclear if the program plans to change that policy.

There’s also concern that there could be too few specialist physicians and locations to administer the infusions if Leqembi is broadly embraced as a treatment and patient demand for the antibody is high.

Some studies have estimated that wait times for antibody treatments like Leqembi could range from months to even years over the next decade depending on demand.

Tomas Philipson, who advised the FDA commissioner and CMS administrator during the second Bush administration, said the registry is an unnecessary hurdle and Medicare should drop it, but he doesn’t believe the requirement will create an insurmountable barrier to patients accessing Leqembi.

If demand for Leqembi is high, doctors will have an incentive to participate in the registry and the drug companies will want to help, said Philipson, an expert on health-care economics at the University of Chicago.

How high demand will be for Leqembi is uncertain, he said. Families worried about the serious side effects may opt not to take the treatment, while others will decide the benefits outweigh those risks, he said.

High cost

Leqembi’s price tag and the treatment’s benefit-risk profile are controversial.

Medicare patients treated with Leqembi will pay 20% of the medical bill after they meet their Part B deductible, according to CMS. Costs may vary depending on whether the patient has supplemental Medicare coverage or other secondary insurance, according to the agency.

Patients could face up to $6,600 in annual out-of-pocket costs for Leqembi even with Medicare coverage, according to a study published in the journal JAMA Internal Medicine. The treatment could cost Medicare up to $5 billion a year depending on how many people receive the infusions, the study estimated.

Sen. Bernie Sanders, I-Vt., chair of the Senate Health Committee, has called Leqembi’s price “unconscionable” and in a letter last month asked Health and Human Services Secretary Xavier Becerra to take action to reduce the cost.

Sanders said patient out-of-pocket costs for Leqembi would amount to a sixth of many seniors’ total annual income and noted the high cost of the treatment could increase premiums for everyone on Medicare.

Eisai says its $26,500 annual list price for Leqembi is lower than the company’s estimate of $37,600 for the total value of the treatment for each patient. The Institute for Clinical and Economic Review, a nonprofit that analyzes health-care costs, estimated in April it should be priced at $8,900 to $21,500 per year.

Though Leqembi could prove costly to Medicare, Philipson said delaying coverage of the treatment would result in significant increased health-care spending as people with mild Alzheimer’s disease, which can be managed at home, progress to more serious disease that requires expensive nursing home care.

Philipson and his colleagues at the University of Chicago estimated that delaying Medicare coverage of Alzheimer’s antibody treatments by one year would result in $6.8 billion in increased spending. By 2040, health-care spending would rise by $248 billion.

Clinical benefit

Thursday’s full FDA approval comes after a panel of six outside advisors voted unanimously in June in support of the drug’s clinical benefit to patients. The panel was unusually small because some members recused themselves due to conflicts of interest.

The American Academy of Neurology stated in a February letter to CMS that there is a consensus among its experts that Eisai’s clinical trial of Leqembi was well designed and the results were “clinically and statistically significant.”

Some nonprofit groups such as Public Citizen, a consumer advocacy organization, strongly opposed FDA approval of Leqembi. A representative from Public Citizen told the advisory panel that the evidence for the drug’s benefit does not outweigh significant risks of brain swelling and bleeding.

And representatives from the National Center for Health Research and Doctors for America, also nonprofits, told the panel that Eisai’s clinical trial did not include enough Black patients, who are at higher risk for Alzheimer’s disease.

Leqembi has technically been approved for the U.S. market since January, when the FDA cleared the treatment under an accelerated pathway. The FDA uses expedited approvals to save time and get drugs to patients suffering from serious diseases more quickly.

But Medicare refused to cover the Leqembi at that time, asking for more evidence that the expensive treatment had a real clinical benefit for patients that outweighed the risks.

The program’s cautious coverage policy stems from the FDA’s controversial 2021 approval of another Alzheimer’s antibody treatment called Aduhelm, also made by Eisai and Biogen.

The FDA’s advisory committee declined to endorse Aduhelm because the data did not support a clinical benefit to patients. Three advisors resigned after the agency’s decision to approve the treatment anyway.

Knopman is one of the advisors who resigned over the FDA’s decision on Aduhelm. He said the data for Leqembi is different. Eisai conducted a clean trial that showed the antibody had a modest clinical benefit for patients, Knopman said.

An investigation by Congress subsequently found that the FDA’s approval of Aduhelm was “rife with irregularities.”

Sanders, in his letter to Becerra, said the FDA “has a special responsibility to restore the public trust after its inappropriate relationship with Biogen during the agency’s review of a prior Alzheimer’s drug, Aduhelm.”

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Older dogs who sleep badly may have dementia, study says | CNN



CNN
 — 

In a veterinary lab in North Carolina, Woofus, a 15-year-old basset hound mix, is allowing researchers to attach an electroencephalogram, or EEG, electrodes to his head before padding off to a dark, cozy room for an afternoon nap.

During his snooze, the study team will analyze Woofus’ brain waves to judge the quality of his sleep. Woofus has canine cognitive dysfunction syndrome, or CCDS, the doggie disorder that’s similar to Alzheimer’s disease in people. The elderly dog’s owners say he is struggling to get enough rest at night.

“Just like humans with Alzheimer’s disease, dogs with CCDS experience sleep disruptions, such as insomnia and sleep fragmentation,” said veterinarian Dr. Natasha Olby, a professor of neurology, neurosurgery and gerontology at North Carolina State College of Veterinary Medicine in Raleigh.

Woofus isn’t the only sleep-deprived dog in this study. On other days in the clinic, Jake, a 13-year-old pointer, and Coco, a 12-year-old dachshund, among others, might be taking a siesta while researchers peer inside their brains.

“Owners of dogs with CCDS report their dogs suffer from difficulty sleeping at night, increased sleeping during the day or both, as well as pacing and vocalizations at night,” Olby said. “This can be very hard on the dog’s owners — not only are they worried for their pet, their sleep is also significantly disrupted.”

To find out whether sleep problems in dogs indicate early signs of dementia as they do in people, Olby and her team turned to a group of senior dogs enrolled in an ongoing study testing antiaging supplements. The dogs visit twice a year “and do all kinds of really fun cognitive testing,” she said. “They really enjoy it and like the handlers they work with.”

To be considered for the antiaging study, the dog must have lived more than 75% of the expected life span for their breed or mix of breeds. A dog also could not be crippled by arthritis or going blind, as the pet needed to be able to perform tasks designed to test their cognitive capabilities.

A dog might be asked, for example, to find a treat hidden under a cup or a snack inside a cylinder in which one end had been closed by a researcher. By repeating the tasks at the clinic every six months, any decline in the dog’s mental agility or performance can be tracked.

Woofus, 15-year-old basset hound mix, plays

For the new study measuring a dog’s brain waves during sleep, researchers used a form of electroencephalogram called polysomnography, used in sleep clinics to diagnose sleep problems in people.

“It’s the gold standard method to look at what the brain is doing during sleep,” Olby said, adding this is the first canine study to apply the same technology used on humans.

“We glue these electrodes on with a really great conductive glue that’s water soluble. Then we just wash it off afterwards,” she said. “We don’t use anywhere near as many electrodes as you see on people in a sleep lab, because dogs have far less cortex and surface area to cover.”

Already at ease with the staff, it wasn’t too difficult to train 28 senior dogs to wear electrodes and walk around with dangling wires without complaint, she said.

Jake, a 13-year-old pointer, was one of 28 dogs trained to sleep with EEG electrodes.

To make the dogs more comfortable during their siestas, owners bring their dogs’ beds from home, which are placed in a protected room with white noise.

“Staff sit with them while they nap to make sure that they’re not trying to pull out or eat the electrodes or do anything that might hurt them,” Olby said.

When sleeping brain waves were compared with a dog’s cognitive testing, researchers found that dogs with greater dementia spent less time in deep and REM sleep, just as people do. The study was recently published in the journal Frontiers in Veterinary Science.

“Dogs that did worse on our memory tests had levels of REM sleep which were not as deep as they should be,” Olby said. “We found the same when it came to deep sleep.”

While no one knows the exact mechanism at work — either in people or in dogs — research like this study may help scientists better understand the process and find ways to treat it, Olby said.

“There’s a possibility we might be able to identify an early signature of change on the EEG that can tell us, ‘Hey, things are starting to slide.’ Because with a chronic neurodegenerative process, of course we’d love to be able to intervene sooner rather than later.”

In the meantime, there are medications for anxiety and melatonin for sleep that veterinarians can prescribe as a dog ages, Olby said. And as with people, diet and exercise appears to be a factor.

“There’s been some very nice studies showing diets that are enriched in flavonoids and antioxidants and medium-chain fatty acids could possibly slow the development of dementia in dogs,” she said. “It’s just like people — if you can eat a Mediterranean diet and do your exercise, you’re going to do better.”

Doggie dementia is a worrisome reality for many senior dogs. Research has found that by 11 or 12 years of age, 28% of dogs had mild and 10% had severe cognitive impairment. By the time the dogs reached age 15, the risk had risen to 68% for mild and 35% for severe cognitive impairment. A 2022 study found the odds of canine cognitive dysfunction increased by 52% with each year of age, Olby said.

Pet owners can look for signs that their dog’s mental functions are declining. According to Olby, vets use an acronym called DISHA-AL, which stands for disorientation, interaction changes, sleep/wake cycle alterations, house soiling; activity changes (increased or decreased); and anxiety and learning & memory.

“One of the earliest signs is you’ll start to see a little confusion just like you do with people, they suddenly start to make some mistakes and things you wouldn’t expect them to do. Very similar to us,” Olby said.

Dogs may also lose learned behaviors, or forget their house training and begin to have unintentional accidents around the house, she added.

“A classic problem is wandering around and getting lost under the table or something — they just can’t process the information and figure out where they are. Changes in sleep cycle, increased anxiety, all of these things are classic signs of dementia,” she said.

Don’t assume that is what is wrong with your dog, however. Just like in people, other health problems such as metabolic disease, urinary tract infections or even brain tumors can mimic classic signs of dementia.

“High blood pressure can make dogs anxious, for example,” Olby said, “so a vet needs to thoroughly check the dog to rule out disease.”

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Regular internet use may be linked to lower dementia risk in older adults, study says | CNN



CNN
 — 

If your parents or grandparents ask you how to post on Instagram or how to send a birthday message to a Facebook friend, a new study suggests you might want to help them – not just to be nice but because getting them online may help their brain health, too.

A study published Wednesday in the Journal of the American Geriatrics Society suggested that older people who regularly used the internet were less likely to develop dementia.

The researchers saw this association after about eight years tracking 18,154 adults between the ages of 50 and 65 who did not have dementia when the study period began.

The adults were a part of the Health and Retirement Study, a multidisciplinary collection of data from a representative sample of people in the US that is gathered by the National Institute on Aging and the Social Security Administration.

Each of the participants was asked a simple question: “Do you regularly use the World Wide Web, or the Internet, for sending and receiving e-mail or for any other purpose, such as making purchases, searching for information, or making travel reservations?”

People who used the internet at the start of the study had about half the risk of dementia as people who were not regular users.

The researchers also looked at how often these adults were online, from not at all to more than eight hours a day. Those who used the internet for about two hours or less a day had the lowest risk of dementia compared with those that didn’t use the internet, who had a “notably higher estimated risk.”

The researchers noted that people who were online six to eight hours a day had a higher risk of dementia, but that finding wasn’t statistically significant, they said, and more research is needed.

Scientists still don’t know what causes dementia, so the new research can’t pinpoint the exact connection between internet usage and brain health. Study co-author Dr. Virginia W. Chang has a few ideas.

“Online engagement may help to develop and maintain cognitive reserve, which can in turn compensate for brain aging and reduce the risk of dementia,” said Chang, an associate professor of global public health at New York University’s School of Global Public Health.

The study also did not look at what people were exploring online. Although the internet is full of cat videos and conspiracy theories, it can also be intellectually stimulating, and some studies have shown that intellectual stimulation may help prevent dementia. A 2020 study found an association between cognitively stimulating jobs and a lower risk of dementia, for example.

As people age, it’s natural for brain processing speeds to slow a little, and it may get harder to remember what’s on all those open browser tabs on your computer. But in a healthy brain, routine memory and knowledge remains pretty stable. People with dementia have trouble with routine brain functions like making new memories, solving problems and completing normal tasks.

About 6.2 million people 65 and older have Alzheimer’s disease, the most common form of dementia, the US Centers for Disease Control and Prevention says. That number is expected to grow exponentially as baby boomers age.

“Overall, this is important research. It identifies another potentially modifiable factor that might influence dementia risk,” said Dr. Claire Sexton, the Alzheimer’s Association’s senior director of scientific programs and outreach, who was not involved in the new study. “But we wouldn’t want to read too much into this study in isolation. It doesn’t establish cause and effect.”

Beyond medications, experts have been looking for ways to help people keep dementia at bay.

The Alzheimer’s Association is working on the US Pointer Study, a two-year clinical trial to pinpoint exactly what lifestyle interventions may lower a person’s risk of dementia.

Risk factors like family history and age can’t be changed, but scientists think there are some healthy behaviors that can reduce the risk of this kind of cognitive decline.

Lifestyle factors like exercise, getting enough sleep, maintaining a healthy weight, keeping blood pressure in check, managing blood sugar, quitting smoking and staying engaged with others may help. Internet surfing isn’t one of the official activities listed by the CDC, but the new study adds to the growing body of evidence that suggests more research could better establish this connection.

The new research isn’t the first to find that the use of the internet may help reduce cognitive decline. One 2020 study found only a smaller cognitive decline in male internet users. Others have not seen a gender difference.

In the latest study, the difference in risk between regular users and those who did not use the internet regularly did not vary by gender, level of education, or race or ethnicity.

Some studies have also shown a benefit to training older adults on computers and have suggested that the internet can positively connect them to others and help them learn information or skills.

Research also suggests that most older adults most frequently use the internet for basic tasks like email, news or online banking. But a growing number are learning newer social platforms like BeReal or dancing and singing on TikTok. And learning new skills may be protective against dementia, studies suggest.

Older adults’ use of social networking sites can also increase their connections to other people and reduce isolation. Some studies have shown that older people who were lonely were three times more likely to develop dementia than those who said they felt socially connected to others.

“We need further evidence, not just from observational studies like this one but also interventional studies,” Sexton said. That way, doctors might someday treat people for dementia like they do with heart disease: by suggesting lifestyle changes in addition to medication.

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Dementia risk rises if you live with chronic pain, study says | CNN



CNN
 — 

Chronic pain, such as arthritis, cancer or back pain, lasting for over three months, raises the risk of cognitive decline and dementia, a new study found.

The hippocampus, a brain structure highly associated with learning and memory, aged by about a year in a 60-year-old person who had one site of chronic pain compared with people with no pain.

When pain was felt in two places in the body, the hippocampus shrank even more — the equivalent of just over two years of aging, according to estimates in the study published Monday in the journal Proceedings of the National Academy of Sciences, or PNAS.

“In other words, the hippocampal (grey matter volume) in a 60-y-old individual with (chronic pain) at two body sites was similar to the volume of (pain free) controls aged 62-y-old,” wrote corresponding author Tu Yiheng and his colleagues. Tu is a professor of psychology at the Chinese Academy of Sciences in Beijing.

The risk rose as the number of pain sites in the body increased, the study found. Hippocampal volume was nearly four times smaller in people with pain in five or more body sites compared with those with only two — the equivalent of up to eight years of aging.

“Asking people about any chronic pain conditions, and advocating for their care by a pain specialist, may be a modifiable risk factor against cognitive decline that we can proactively address,” said Alzheimer’s disease researcher Dr. Richard Isaacson, a preventive neurologist at the Institute for Neurodegenerative Diseases of Florida. He was not involved in the new study.

The study analyzed data from over 19,000 people who had undergone brain scans as part of the UK Biobank, a long-term government study of over 500,000 UK participants between the ages of 40 and 69.

People with multiple sites of body pain performed worse than people with no pain on seven of 11 cognitive tasks, the study found. In contrast, people with only one pain site performed worse on only one cognitive task — the ability to remember to perform a task in the future.

The study controlled for a variety of contributing conditions — age, alcohol use, body mass, ethnicity, genetics, history of cancer, diabetes, vascular or heart problems, medications, psychiatric symptoms and smoking status, to name a few. However, the study did not control for levels of exercise, Isaacson said.

“Exercise is the #1 most powerful tool in the fight against cognitive decline and dementia,” he said via email. “People affected by multisite chronic pain may be less able to adhere to regular physical activity as one potential mechanism for increased dementia risk.”

Equally important is a link between chronic pain and inflammation, Isaacson said. A 2019 review of studies found pain triggers immune cells called microglia to create neuroinflammation that may lead to changes in brain connectivity and function.

People with higher levels of pain were also more likely to have reduced gray matter in other brain areas that impact cognition, such as the prefrontal cortex and frontal lobe — the same areas attacked by Alzhemier’s disease. In fact, over 45% of Alzheimer’s patients live with chronic pain, according to a 2016 study cited by the review.

The study was also not able to determine sleep deficits — chronic pain often makes getting a good night’s sleep difficult. A 2021 study found sleeping less than six hours a night in midlife raises the risk of dementia by 30%.

Globally, low back pain is a leading cause of years lived with disability, with neck pain coming in at No. 4, according to the 2016 Global Burden of Disease Study. Arthritis, nerve damage, pain from cancer and injuries are other leading causes.

Researchers estimate over 30% of people worldwide suffer with chronic pain: “Pain is the most common reason people seek health care and the leading cause of disability in the world,” according to articles published in the journal The Lancet in 2021.

In the United States alone, at least 1 in 5 people, or some 50 million Americans, live with long-lasting pain, according to the US Centers for Disease Control and Prevention.

Nearly 11 million Americans suffer from high-impact chronic pain, defined as pain lasting over three months that’s “accompanied by at least one major activity restriction, such as being unable to work outside the home, go to school, or do household chores,” according to the National Center for Complementary and Integrative Health.

Chronic pain has been linked to anxiety, depression, restrictions in mobility and daily activities, dependence on opioids, increased health care costs, and poor quality of life. A 2019 study estimated about 5 million to 8 million Americans were using opioids to manage chronic pain.

Pain management programs typically involve a number of specialists to find the best relief for symptoms while providing support for the emotional and mental burden of pain, according to John Hopkins Medicine.

Medical treatment can include over-the-counter and prescription medications to stop the pain cycle and ease inflammation. Injections of steroids may also help. Antidepressants increase the amount of serotonin, which controls part of the pain pathway in the brain. Applying brief bursts of electricity to the muscles and nerve endings is another treatment.

Therapies such as massage and whirlpool immersion and exercises may be suggested by occupational and physical therapists. Hot and cold treatments and acupuncture may help as well.

Psychologists who specialize in rehabilitation may recommend cognitive and relaxation techniques such as meditation, tai chi and yoga that can take the mind off fixating on pain. Cognitive behavioral therapy is a key psychological treatment for pain.

Going on an anti-inflammatory diet may be suggested, such as cutting back on trans fats, sugars and other processed foods. Weight loss may be helpful as well, especially for back and knee pain, according to Johns Hopkins.

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Alcohol and dementia: Study finds benefits in minimal drinking, but it’s complicated | CNN



CNN
 — 

Keeping alcohol consumption to one or two drinks a day lessened the odds of developing dementia, according to a study of nearly 4 million South Koreans.

However, drinking more than two drinks a day increased that risk, according to the study published Monday in the journal JAMA Network Open.

“We found that maintaining mild to moderate alcohol consumption as well as reducing alcohol consumption from a heavy to moderate level were associated with a decreased risk of dementia,” said first author Dr. Keun Hye Jeon, an assistant professor at CHA Gumi Medical Center, CHA University in Gumi, South Korea, in an email.

But don’t rush to the liquor store, experts say.

“This study was well done and is extremely robust with 4 million subjects, but we should be cautious not to over interpret the findings,” said Alzheimer’s researcher Dr. Richard Isaacson, a preventive neurologist at the Institute for Neurodegenerative Diseases of Florida. He was not involved in the new study.

Alcohol use can be a risk factor for breast and other cancers, and consuming too much can contribute to digestive problems, heart and liver disease, hypertension, stroke, and a weak immune system over time, according to the US Centers for Disease Control and Prevention.

There are red flags for Alzheimer’s as well. For example, if a person has one or two copies of the APOE4 gene variant, which raises your risk of developing the mind-wasting disease, drinking is not a good choice, Isaacson said.

“Alcohol has been shown to be harmful for brain outcomes in people with that risk gene — and about 25% of the US population carries one copy of APOE4,” he said.

The new study examined the medical records of people covered by the Korean National Health Insurance Service (NHIS), which provides a free health exam twice a year to insured South Koreans who are 40 and older. In addition to doing various tests, examiners asked about each person’s drinking, smoking and exercise habits.

The study looked at the data collected in 2009 and 2011 and categorized people by their self-reported drinking levels. If a person said they drank less than 15 grams (approximately 0.5 ounces) of alcohol a day, they were considered “mild” drinkers.

In the United States, a standard drink contains 14 grams of alcohol, which is roughly the same as 12 ounces of regular beer, 5 ounces of wine or 1.5 ounces of distilled spirits.

If study participants told doctors they drank 15 to 29.9 grams a day — the equivalent of two standards drinks in the US — the researchers categorized them as “moderate” drinkers. And if people said they drank over 30 grams, or three or more drinks a day, researchers considered them “heavy” drinkers.

Researchers also looked at whether people sustained or changed the amount they drank between 2009 and 2011, Jeon said.

“By measuring alcohol consumption at two time points, we were able to study the relationship between reducing, ceasing, maintaining and increasing alcohol consumption and incident dementia,” he said.

The team then compared that data to medical records in 2018 — seven or eight years later — to see if anyone studied had been diagnosed with dementia.

After adjusting for age, sex, smoking, exercise level and other demographic factors, researchers found people who said they drank at a mild level over time — about a drink a day — were 21% less likely to develop dementia than people who never drank.

People who said they continued to drink at moderate level, or about two drinks a day, were 17% less likely to develop dementia, the study found.

“One has to be cautious when interpreting studies using medical records. They can be fraught with challenges in how diseases are coded and studied,” Isaacson said. “Any anytime you ask people to recall their behaviors, such as drinking, it leaves room for memory errors.”

The positive pattern did not continue as drinking increased. People who drank heavily — three or more drinks a day — were 8% more likely to be diagnosed with dementia, the study found.

If heavy drinkers reduced their drinking over time to a moderate level, their risk of being diagnosed with Alzheimer’s fell by 12%, and the risk of all-cause dementia fell by 8%.

However, people aren’t very good at judging how much alcohol they are drinking, Isaacson said.

“People don’t really monitor their pours of wine, for example,” Isaacson said. “They may think they are drinking a standard-sized glass of wine, but it’s really a glass and a half every time. Drink two of those pours and they’ve had three glasses of wine. That’s no longer mild or moderate consumption.”

In addition, too many people who think they are moderate drinkers do all of their drinking on weekends. Binge drinking is on the rise worldwide, even among adults, studies show.

“If someone downs five drinks on Saturday and Sunday that’s 10 drinks a week so that would qualify as a moderate alcohol intake,” Isaacson said. “To me, that is not that is not the same as having a glass of wine five days a week with a meal, which slows consumption.”

The new study also found that starting to drink at a mild level was associated with a decreased risk of all-cause dementia and Alzheimer’s, “which, to our knowledge, has never been reported in previous studies,” the authors wrote.

However, “none of the existing health guidelines recommends starting alcohol drinking,” Jeon said, adding that since the study was observational, no cause and effect can be determined.

“Our findings regarding a initiation of mild alcohol consumption cannot be directly translated into clinical recommendations, thereby warranting additional studies to confirm these associations further,” Jeon said.

A study published in March 2022 found that just one pint of beer or glass of wine a day can shrink the overall volume of the brain, with the damage increasing as the number of daily drinks rises.

On average, people between 40 and 69 who drank a pint of beer or 6-ounce glass of wine per day for a month had brains that appeared two years older than those who only drank half of a beer, according to that previous study.

“I’ve never personally suggested someone to start drinking moderate amounts of alcohol if they were abstinent,” Isaacson said. “But there’s really not a one-size-fits-all approach towards counseling a patient on alcohol consumption.”

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Report shares new details about death possibly linked to experimental Alzheimer’s drug | CNN



CNN
 — 

The death of a participant in a clinical trial of an antibody treatment for Alzheimer’s disease, which is now under consideration by the US Food and Drug Administration, may be linked to the experimental drug, a new report shows.

The research letter, published Wednesday in the New England Journal of Medicine, shares details about what happened to the participant in the open-label extension phase of the trial of lecanemab.

In an open-label extension, there is no placebo arm; rather, all the participants get the medication in question because an earlier part of the trial has shown so much potential.

In this case, a 65-year-old who was in the early stages of Alzheimer’s was taken to an emergency room in a Chicago-area hospital within 30 minutes of the first signs of a stroke, the report says. Doctors at the Northwestern University Feinberg School of Medicine learned that the patient had gotten infusions of lecanemab four days before.

This patient is not the only one to die during the open-arm extension. The health publication Stat reported that an investigator told it about the death of another participant who had bleeding in the brain that may have been related to the drug. In that case, drugmaker Eisai pointed to other possible factors.

Lecanemab is meant to slow the progression of Alzheimer’s. In November, the company released a study showing that it slowed the progression of cognitive decline by 27% compared with a placebo. It also reduced amyloid levels – a protein that is one of the hallmarks of Alzheimer’s – and had positive effects on cognition and the ability to perform everyday tasks when compared with a placebo.

The research also showed that about 2.8% of trial participants who took the drug had a symptomatic side effect called ARIA-E, which involves swelling in the brain. None of the participants who got a placebo had that.

The new report says the medical team at the hospital gave the patient a common medication to break up blood clots that could cause a stroke, called t-PA bolus. Nothing in the patient’s medical background suggested that they would have a problem with that drug. But less than an hour into the treatment, their blood pressure shot up, so doctors stopped the infusion.

A CT scan showed extensive bleeding in the brain.

The doctors then administered a medicine that can control the bleeding, but the patient became severely agitated and developed communication problems. The patient also had frequent nonconvulsive seizures.

The medical team was able to treat the seizures, but the person’s condition did not get better.

After three days in the hospital, the person got a tube in their windpipe to help them breathe. Even with that and other supportive care, the patient died.

An autopsy showed that the patient had extensive brain bleeding and amyloid deposits within many of the blood vessels in their brain that probably contributed to the hemorrhage, the report said.

Essentially, the report says, the blood vessels in the patient’s brain must have burst after being exposed to the blood clot medicine t-PA.

“The extensive number and variation in sizes of the cerebral hemorrhages in this patient would be unusual as a complication of t-PA solely related to cerebrovascular amyloid,” the report says. But the combination of the clot-busting drug with lecanemab may have led to the cerebral hemorrhages.

Northwestern Medicine declined CNN’s request to interview the authors of the new report but said in a statement that it was “an effort to provide relevant data to the medical and scientific community.”

Eisai said it did not have an official response because of patient privacy.

The company and Northwestern Medicine pointed to a response published alongside the new report from clinicians and researchers who were involved in the lecanemab clinical trials.

Drs. Marwan Sabbagh and Christopher H. van Dyck wrote in that response that they “agree that this case raises important management issues for patients with Alzheimer’s disease.”

It is an “unusual case, and we understand why the authors want to highlight a potential concern,” they said.

Their response also pointed to other potential factors in the deaths of both trial participants.

In this case, the brain bleed could have been connected to a period of time after the stroke when the patient’s blood pressure was exceptionally high, they said. And the other trial participant was taking a drug for atrial fibrillation that may have been a contributing factor.

The doctors also write in the response that other patients who have gotten t-PA have died with these amyloid deposits within blood vessels in the brain.

Dr. Sharon Cohen, a behavioral neurologist who works with Alzheimer’s patients at the Toronto Memory Program and an investigator in the lecanemab trial, says it’s been difficult to develop a therapeutic for Alzheimer’s.

Cohen said that doctors have known for years that almost all of the drugs in this class can come with a side effect of ARIA, which stands for amyloid-related imaging abnormalities.

The safety of the drug “looks very acceptable,” she said. “It’s within the range of adverse events that we expected and seems very reasonable for this patient population.”

The rate of bleeding in the trial is considered very low, and most of the microbleeds seen in the trial have been asymptomatic, she said.

In the case of the patient in the new report, Cohen thinks the death was probably related to the blood clot drug but said the combination of that drug and lecanemab “gives us pause.”

If the FDA approves the treatment, there may be some discretion in terms of patient choice and what the prescribing physician feels is best for for someone who is taking anticoagulants or has other risk factors for hemorrhaging, she said.

In general, lecanemab has in many ways exceeded our expectations, she said, “because we haven’t seen such consistently positive results in an Alzheimer’s disease modification trial at all until now.”

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1 in 10 Americans over 65 have dementia, study finds | CNN





CNN
 — 

One in 10 Americans over 65 had dementia, while 22% experienced mild cognitive impairment, the earliest stage of the slow slide into senility, according to a new study conducted between 2016 and 2017.

The research, which the authors said is the first nationally representative examination of cognitive impairment prevalence in more than 20 years, was able to measure prevalence of dementia and mild cognitive impairment by age, education, ethnicity, gender and race.

The results showed older adults who self-identified as Black or African American were more likely to have dementia, while those who identify as Hispanic were more likely to suffer from mild cognitive impairment. People who had less than a high school education were more likely to have both conditions.

“Dementia research in general has largely focused on college-educated people who are racialized as white,” lead study author Jennifer Manly said in a statement.

“This study is representative of the population of older adults and includes groups that have been historically excluded from dementia research but are at higher risk of developing cognitive impairment because of structural racism and income inequality,” said Manly, professor of neuropsychology at the Gertrude H. Sergievsky Center and the Taub Institute for Research on Alzheimer’s Disease and the Aging Brain at Columbia University.

“If we’re interested in increasing brain health equity in later life, we need to know where we stand now and where to direct our resources,” Manly said.

The study, published Monday in the journal JAMA Neurology, analyzed data from in-depth neuropsychological tests and interviews with nearly 3,500 people over age 65 enrolled in the Health and Retirement Study, a long-term research project sponsored by the National Institute on Aging and the Social Security Administration.

The research was based on a randomly selected sample of people from the study that completed the core survey and underwent neurological testing between June 2016 and October 2017.

Fifteen percent of people who identified as Black tested positive for dementia, while 22% had mild cognitive decline, the study found. Ten percent of people who identified as Hispanic had dementia, but the rate of milder issues was higher — 28% tested positive for mild cognitive impairment. Nine percent of White people had dementia, while 21% had mild cognitive impairment.

Educational achievement, which experts consider to be protective against cognitive decline, showed a significant divide: Nine percent of people with a college degree tested positive for dementia, compared with 13% of those who never received a high school diploma. Twenty-one percent of people over 65 with college degrees had mild cognitive decline, compared with 30% of those with less than a high school degree.

The extreme elderly had the highest rates of dementia and mild cognitive impairment. Only 3% of adults between 65 and 69 tested positive for dementia, compared with 35% of those 90 and older.

In fact, every five-year increase in age was associated with higher risk of dementia and mild cognitive impairment, the report said. The study, however, found no differences between men and women in rates of either condition

Symptoms of mild cognitive impairment can include losing items, forgetting to do things or go to appointments, or struggling to come up with words. A loss of smell and taste and movement issues can also be symptoms, according to the National Institute on Aging.

People with mild cognitive impairment are fully capable of taking care of themselves, “but what they have to go through to do so is exhausting,” Laura Baker, a professor of gerontology and geriatric medicine at Wake Forest University School of Medicine in Winston-Salem, North Carolina, told CNN in an earlier interview. She was not involved in the current study.

People with mild cognitive impairment may not remember where they are supposed to be, Baker said. ” ‘Let me check my calendar. Oh, I forgot to write on this calendar. Let’s check another calendar. Oh, I can’t find that calendar. I’ve lost my phone. Where is the key? I can’t find the key.’ They’re able to regroup in the early stages and accomplish things, but the toll is immense.”

Not everyone with mild cognitive impairment goes on to develop dementia, although many do, experts say. Lifestyle changes may be a key to reversing mental decline. A 2019 study found personalized lifestyle interventions -— such as diet, exercise, stress reduction and sleep hygiene — not only stopped cognitive decline in people at risk for Alzheimer’s, but actually increased their memory and thinking skills over 18 months. Women responded better than men, a follow-up study found.

A February study found about a third of women 75 years or older with mild cognitive impairment reversed their progression to dementia at some point during follow-up. All of the women, however, had high levels of education and academic performance and excellent written language skills, or what experts call “cognitive reserve.”

Signs of dementia can differ from one person to the next, and can include memory loss and confusion, difficulty speaking, understanding and expressing thoughts, or reading and writing, according to the National Institutes of Health.

People with dementia can act impulsively or show poor judgment, and they can have trouble paying bills or handling money responsibly. They may repeat questions, use strange words to refer to familiar objects and take longer than usual to complete daily tasks.

Wandering and getting lost in a familiar neighborhood is another sign of dementia, as is losing interest in daily activities or events or acting as if they don’t care about other people’s feelings. They may lose their balance or have other problems with movement. At times, people with dementia can hallucinate or experience delusions or paranoia.

Alzheimer’s disease is the most well-known cause of dementia, but cognitive issues can be caused by vascular problems that block the flow of blood to the brain or via ministrokes caused by tiny blood clots traveling to the brain. Frontal lobe dementia, a rare form thought to be associated with abnormal amounts of the proteins tau and TDP-43, often begins in people younger than 60. Another type of decline, called Lewy body dementia, is thought to be caused by abnormal deposits of the protein alpha-synuclein, which are called Lewy bodies.

A person with signs of cognitive decline or dementia needs a full workup by a neurologist to determine the underlying cause, the NIH said. Side effects from a number of medications can mimic dementia, as can certain diseases, such as Huntington’s disease.

If you’ve just been diagnosed with dementia, continue to meet with doctors and specialists and consider asking for a referral to a memory clinic, according to the National Institutes of Health. Reach out to your local Alzheimer’s Disease Research Center and consider joining a clinical trial.

The Alzheimer’s Association has detailed information on the differences between dementia and Alzheimer’s, and it offers many levels of support for both patients and caregivers.

Work on staying healthy — exercise helps with mood, balance and thinking, while eating a well-balanced diet and getting quality sleep can improve the brain’s ability to function.



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