Health
Alzheimer’s Drug Slows Cognitive Decline in Key Study
The pharmaceutical firms Biogen and Eisai stated on Tuesday {that a} drug they’re creating for Alzheimer’s illness had slowed the speed of cognitive decline in a big late-stage scientific trial.
The sturdy outcomes enhance the drug’s possibilities of successful approval and provide renewed hope for a category of Alzheimer’s medicine which have repeatedly failed or generated combined outcomes.
The optimistic knowledge additionally provide Biogen a second likelihood after the corporate’s disastrous rollout of one other Alzheimer’s drug, Aduhelm. That treatment received regulatory approval final 12 months regardless of little proof that it may gradual cognitive decline, obtained solely sharply restricted protection by Medicare and has proved to be a industrial failure.
The outcomes seem stronger for the brand new treatment, lecanemab. Cognitive decline within the group of volunteers who obtained lecanemab was lowered by 27 % in contrast with the group who obtained a placebo within the scientific trial, which enrolled almost 1,800 members with gentle cognitive impairment or gentle Alzheimer’s illness, the businesses stated.
The trial of lecanemab, which is run through intravenous infusion, was the biggest up to now to check whether or not clearing the mind of plaques shaped by the buildup of a protein referred to as amyloid may gradual the development of Alzheimer’s illness. Aduhelm is designed to work in an analogous means.
As with earlier anti-amyloid medicine, some sufferers taking lecanemab skilled mind swelling or mind bleeding, however the prevalence of those unwanted effects was decrease than with Aduhelm and different experimental medicines.
Eisai had already utilized for accelerated approval, the kind of approval given to Aduhelm. The method permits the Meals and Drug Administration to greenlight medicine if they’ve unsure proof of profit however have an effect on a illness’s organic pathway in a means that’s thought-about fairly more likely to profit sufferers. The corporate stated on Tuesday evening that it could first proceed with the accelerated approval course of, with an F.D.A. choice anticipated by early January, after which use the newer knowledge to hunt full approval. (Accelerated approval requires firms to do additional trials and show that their drug works.)
Analysts predict that lecanemab, or any efficient Alzheimer’s treatment, would most probably be a multibillion-dollar blockbuster.
“For Biogen, it places them again within the Alzheimer’s sport,” Brian Skorney, an analyst on the funding financial institution Baird, stated.
In a briefing for reporters Tuesday evening, Ivan Cheung, the chairman and chief govt of Eisai, stated the outcomes represented “the primary definitively optimistic giant scientific trial to point out you can certainly decelerate Alzheimer’s illness at this very early symptomatic stage.”
He stated that the drug began to point out a profit to sufferers about six months after they started taking it and that the profit elevated till the trial ended, 18 months after sufferers began on the drug.
The businesses plan to current extra detailed leads to November.
Some specialists stated the drug’s means to gradual cognitive decline — by 0.45 on an 18-point scale — was modest at finest and may not be a distinction that sufferers within the gentle early levels of the illness would discover.
Dr. Lon Schneider, director of the California Alzheimer’s Illness Heart on the College of Southern California, stated the impact “is small and wouldn’t be thought-about by many as a minimally clinically vital distinction.” Nonetheless, he added, “others would strongly disagree and say it’s clinically significant.”
Dr. Schneider stated the “comparatively low” charges of mind swelling and bleeding “recommend that lecanemab is simpler to make use of” than Aduhelm.
He added that “though taking a press launch at face worth, which is usually a chancy factor to do with out having actual knowledge or studies, it appears that evidently lecanemab would most probably obtain common advertising approval primarily based on this one research alone.”
Within the briefing, Mr. Cheung stated the corporate thought-about the outcomes “very clinically significant,” however he added, “In fact, there are totally different opinions on the market on defining what scientific meaningfulness is for this stage of illness.”
Different firms are additionally creating remedies that would shake up the marketplace for Alzheimer’s medicine, which earlier than Aduhelm had not seen a novel therapy for twenty years. Earlier than the top of this 12 months, Roche is predicted to report knowledge from two research of a drug often called gantenerumab. The F.D.A. is predicted to decide on whether or not to grant accelerated approval to an Alzheimer’s drug from Eli Lilly often called donanemab by early January, with outcomes from a bigger research of that drug due in the midst of subsequent 12 months.
The outcomes from the research on lecanemab “set a excessive bar that I believe will likely be arduous for the opposite medicine, if they’re profitable, to beat,” Mr. Skorney stated.
Health
3 signs your aging loved one may be ready for assisted living
As Mom and Dad grow older, the big question might be looming in the background: When is the right time to provide living support?
Dr. Macie P. Smith, a licensed social worker and gerontologist based in South Carolina, shared with Fox News Digital that there may be a few telltale signs that it’s time to make a move, whether it’s hiring an at-home aide or seeking out a living facility.
1. They’re at risk of harming themselves
Most importantly, Smith noted that if a senior is at risk of hurting themselves or getting into dangerous situations, it’s most likely time to call in help.
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Smith, who specializes in seniors living with Alzheimer’s disease and cognitive impairment, recommended starting with enlisting at-home aid before pulling a loved one out of their home.
“The last thing anybody wants to lose is their independence,” she said. “The last thing anybody wants is to live in a space with 50 other strangers.”
At-home support can help lower the risk of self-inflicted danger from incidents like leaving the stove on, or mobility issues that could lead to falls.
2. The person is having memory issues
As people age, their capacity to remember things begins to naturally slow down.
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Sometimes, this presents in the form of diseases like Alzheimer’s or dementia. The severity of memory loss in seniors dictates whether living support is necessary, according to experts.
Smith mentioned how forgetting familiar tasks and activities, like eating, can pose a danger to someone’s health.
“If their nutrition is poor, it may be because they are dealing with some pain that they are not expressing to anyone else,” she said. “They may be dealing with some depression and, frankly, they just don’t have the motivation.”
“Respect them enough to have the conversation, because they still have the ability to make decisions about their life.”
The expert advised watching out for signs of spoiled food in the refrigerator.
The person may also forget how to do simple tasks like making a bed, doing laundry, washing the dishes or following cooking instructions.
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“If they’re having trouble cognitively, they’re having trouble making decisions, and that’s going to ultimately impact … how they live independently,” Smith said.
3. They repeat themselves
Repetition of thoughts is also common in individuals living with Alzheimer’s disease and dementia.
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Smith noted that if your loved one is repeating themselves more frequently, it’s a good idea to bring in some support not only for help with day-to-day living, but also for attention and friendship.
“In some cases, it’s because they’re lonely,” she said. “It’s because they’re living by themselves, and they don’t have any type of engagement or motivation.”
‘Very difficult’ decision
Smith emphasized how difficult it can be to make the decision to place a loved one into care, especially if it means removing them from their home.
The senior should “always be a part of the conversation” when it comes to deciding the next steps, she urged.
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“The last thing you want to do is come in and uproot them from the place where they feel the most comfortable and safe, just because you feel they shouldn’t be there,” Smith said.
“Always include them in the conversation, even if they’re in the early stages of dementia,” she encouraged. “They still have a lucidity … to be able to participate in the decision-making process.”
Whether the decision is to bring in care or move somewhere new, Smith said the senior should never be made to feel unsafe or unfamiliar, as this can increase dangerous behaviors, cause agitation and lead to health decline.
The conversation also should not start with the assumption that the senior will not accommodate your request or suggestion.
“Don’t assume they’re not going to remember,” Smith said. “Don’t assume they’re going to be irritable and combative.”
“Respect them enough to have the conversation, because they still have the ability to make decisions about their life.”
Health
Cancer Remission Like Catherine’s Does Not Always Mean the Illness Is Cured
Princess Catherine, wife of Prince William, reported on Tuesday that her cancer was in remission. But what does it mean to be in remission from cancer?
Doctors discovered her cancer unexpectedly last March when she had abdominal surgery. She has not revealed the type of cancer she has, nor how advanced it was when it was discovered.
But she did say she had chemotherapy, which she said had been completed in September. She told the British news agency PA Media that she had a port, a small device that is implanted under the skin and attached to a catheter that goes into a large vein. It allows medicines like chemotherapy drugs to be delivered directly to veins in the chest, avoiding needle sticks.
Catherine told PA Media that chemotherapy was “really tough.”
“It is a relief to now be in remission and I remain focused on recovery,” she wrote on Instagram.
Her announcement “certainly is good news and is reassuring,” said Dr. Kimmie Ng, associate chief of the division of gastrointestinal oncology at the Dana-Farber Cancer Institute in Boston.
But cancer experts like Dr. Ng say that the meaning of remission in a patient can vary.
In general, when doctors and patients talk about remission, they mean there is no evidence of cancer in blood tests or scans.
The problem is that a complete remission does not mean the cancer is gone. Even when a cancer is “cured” — defined as no evidence of cancer for five years — it may not be vanquished.
That makes life emotionally difficult for patients, who have to have frequent visits with oncologists for physical exams, blood tests and imaging.
“It’s really scary,” Dr. Ng said. “The amount of uncertainty is very very hard,” she added.
But that ongoing surveillance is necessary, despite the toll it takes on patients.
“Different cancers have different propensities of returning or not returning,” said Dr. Elena Ratner, a gynecologic oncologist at the Yale Cancer Center.
As many as 75 to 80 percent of ovarian cancers, she noted, can come back in an average of 14 to 16 months after a remission, depending on the stage the cancer had reached when it was found and on the cancer’s biology.
“Once the cancer returns, it becomes a chronic disease,” Dr. Ratner said. She tells her patients: “You will live with this cancer. You will be on and off chemotherapy for the rest of your life.”
Dr. Ratner’s gynecological cancer patients have to come back every three months for CT scans to keep an eye out for evidence that the cancer has returned.
“The women live CT scan to CT scan,” she said. “They say that for two and a half months, they have a wonderful life, but then, in time for the next CT scan, the fear returns.”
“It costs them — it costs them a lot,” she said.
“It’s awful, yet I am amazed every day by their strength,” she said of her patients.
Health
Death Toll in Gaza Likely 40 Percent Higher Than Reported, Researchers Say
Deaths from bombs and other traumatic injuries during the first nine months of the war in Gaza may have been underestimated by more than 40 percent, according to a new analysis published in The Lancet.
The peer-reviewed statistical analysis, led by epidemiologists at the London School of Hygiene and Tropical Medicine, used modeling in an effort to provide an objective third-party estimate of casualties. The United Nations has relied on the figure from the Hamas-led Ministry of Health, which it says has been largely accurate, but which Israel criticizes as inflated.
But the new analysis suggests the Hamas health ministry tally is a significant undercount. The researchers concluded that the death toll from Israel’s aerial bombardment and military ground operation in Gaza between October 2023 and the end of June 2024 was about 64,300, rather than the 37,900 reported by the Palestinian Ministry of Health.
The estimate in the analysis corresponds to 2.9 percent of Gaza’s prewar population having been killed by traumatic injury, or one in 35 inhabitants. The analysis did not account for other war-related casualties such as deaths from malnutrition, water-borne illness or the breakdown of the health system as the conflict progressed.
The study found that 59 percent of the dead were women, children and people over the age of 65. It did not establish what share of the reported dead were combatants.
Mike Spagat, an expert on calculating casualties of war who was not involved in this research, said the new analysis convinced him that Gaza casualties were underestimated.
“This is a good piece of evidence that the real number is higher, probably substantially higher, than the Ministry of Health’s official numbers, higher than I had been thinking over the last few months,” said Dr. Spagat, who is a professor at Royal Holloway College at the University of London.
But the presentation of precise figures, such as a 41 percent underreported mortality, is less useful, he said, since the analysis actually shows the real total could be less than, or substantially more. “Quantitatively, it’s a lot more uncertain than I think comes out in the paper,” Dr. Spagat said.
The researchers said their estimate of 64,260 deaths from traumatic injury has a “confidence interval” between 55,298 and 78,525, which means the actual number of casualties is likely in that range.
If the estimated level of underreporting of deaths through June 2024 is extrapolated out to October 2024, the total Gazan casualty figure in the first year of the war would exceed 70,000.
“There is an importance to war injury deaths, because it speaks to the question of whether the campaign is proportional, whether it is, in fact, the case that sufficient provisions are made to to avoid civilian casualties,” said Francesco Checchi, an epidemiologist with an expertise in conflict and humanitarian crises and a professor at the London School of Hygiene and Tropical Medicine who was an author on the study. “I do think memorializing is important. There is inherent value in just trying to come up with the right number.”
The analysis uses a statistical method called capture-recapture analysis, which has been used to estimate casualties in other conflicts, including civil wars in Colombia and Sudan.
For Gaza, the researchers drew on three lists: The first is a register maintained by the Palestinian Ministry of Health, which mainly comprises the dead in hospital morgues and estimates of the number of unrecovered people buried in rubble. The second is deaths reported by family or community members through an online survey form the ministry established on Jan. 1, 2024, when the prewar death registration system had broken down. It asked Palestinians inside and outside Gaza to provide names, ages, national ID number and location of death for casualties. The third source was obituaries of people who died from injuries that were published on social media, which may not include all of the same biographical details and which the researchers compiled by hand.
The researchers analyzed these sources to look for individuals who appear on multiple lists of those killed. A high level of overlap would have suggested that few deaths were uncounted; the low amount they found suggested the opposite. The researchers used models to calculate the probability of each individual appearing on any of the three lists.
“Models enable us to actually estimate the number of people who have not been listed at all,” Dr. Checchi said. That, combined with the listed number, gave the analysts their total.
Patrick Ball, director of research at the Human Rights Data Analysis Group, and a statistician who has conducted similar estimates of violent deaths in conflicts in other regions, said the study was strong and well reasoned. But he cautioned that the authors may have underestimated the amount of uncertainty caused by the ongoing conflict.
The authors used different variations of mathematical models in their calculations, but Dr. Ball said that rather than presenting a single figure — 64,260 deaths — as the estimate, it may have been more appropriate to present the number of deaths as a range from 47,457 to 88,332 deaths, a span that encompasses all of the estimates produced by modeling the overlap among the three lists.
“It’s really hard to do this kind of thing in the middle of a conflict,” Dr. Ball said. “It takes time, and it takes access. I think you could say the range is larger, and that would be plausible.”
While Gaza had a strong death registration process before the war, it now has only limited function after the destruction of much of the health system. Deaths are uncounted when whole families are killed simultaneously, leaving no one to report, or when an unknown number of people die in the collapse of a large building; Gazans are increasingly buried near their homes without passing through a morgue, Dr. Checchi said.
The authors of the study acknowledged that some of those assumed dead may in fact be missing, most likely taken as prisoners in Israel.
Roni Caryn Rabin and Lauren Leatherby contributed reporting.
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