Study: Wearable sensors more accurately track Parkinson’s disease progression than traditional observation

In a study from Oxford University, researchers found that by using a combination of wearable sensor data and machine learning algorithms the progression of Parkinson’s disease can be monitored more accurately than in traditional clinical observation. Monitoring movement data collected by sensor technology may not only improve predictions about disease progression but also allows for more precise diagnoses.

Parkinson’s disease is a neurological condition that affects motor control and movement. Although there is currently no cure, early intervention can help delay the progression of the disease in patients. Diagnosing and tracking the progression of Parkinson's disease currently involves a neurologist using the Movement Disorder Society-Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) to assess the patient's motor symptoms by assigning scores to the performance of specific movements. However, because this is a subjective, human analysis, classification can be inaccurate.

In the Oxford study, 74 patients with Parkinson’s were monitored for disease progression over a period of 18 months. The participants wore wearables with sensors in different regions of the body: on the chest, at the base of the spine and on each wrist and foot. These sensors — which had gyroscopic and accelerometric capabilities — kept tabs on 122 different physiological measurements, and tracked the patients during walking and postural sway tests. Kinetic data was then analyzed by custom software programs using machine learning.

Wearable sensors provide early detection of progression in Parkinson’s Disease.
Oxford

The sensor data collected by the wearables were compared to standard MDS-UPDRS assessments, which are considered the gold standard in current practice. That traditional test, in this study's patients "did not capture any change" while the sensor-based analysis "detected a statistically significant progression of the motor symptoms" according to the researchers.

Having more precise data on the progression of Parkinson's isn't a cure, of course. But the incorporation of metrics from wearables could help researchers confirm the efficacy of novel treatment options.

This article originally appeared on Engadget at https://www.engadget.com/study-wearable-sensors-more-accurately-track-parkinsons-disease-progression-than-traditional-observation-171132495.html?src=rss

An experimental rice-sized implant monitors how drugs affect tumors

Researchers at Brigham and Women’s Hospital in Boston have developed an implant, notably as small as a grain of rice, that can test the effects of drugs on a patient’s brain tumor in real-time during surgery. Currently, monitoring the effects of drugs on a brain cancer patient during surgery is limited to intraoperative brain imaging and tissue sampling after a drug has been administered. The technique known as microdialysis currently stands as one of the more minimally invasive sampling options for testing the impact of drugs on brain tumors, but even that requires an entire catheter to be inserted into the patient’s skull cavity.

During development, researchers from Brigham and Women’s Hospital designed the device specifically to help test treatments in patients with brain cancers or gliomas, a type of tumor that originates in the brain or spinal cord. The device is designed to only remain implanted in a patient for about two to three hours while it delivers microdoses of the respective drug that is under observation. It can observe the impact of up to 20 drugs on the market for cancerous tumors, according to the researchers. Once the device is removed (sometime before the surgery ends), the surrounding tissue is returned to the lab for analysis.

In a statement published Wednesday, Pierpaolo Peruzzi, co-principal investigator and assistant professor in the Department of Neurosurgery at Brigham and Women’s Hospital said that knowing the impact of cancer drugs on these tumors is critical. “We need to be able to understand, early on, which drug works best for any given patient,” he said.

 Brigham and Women’s Hospital building pictured
Brigham and Women’s Hospital

During the development process, researchers at the Brigham and Women’s Hospital ran a clinical trial to observe the actual impact of the implant on real patients. The study found that none of the patients in the trial experienced any adverse effects. The researchers were able to collect biological data from the devices, such as what molecular changes happened when each drug was administered. While the study demonstrated that the implant could be easily incorporated into surgical practice, the researchers are still determining how the data it can gather should be used to optimize tumor therapy.

The researchers are now conducting another study that focuses on implanting the device through a minimally invasive procedure 72 hours before their main surgery. Advancements in the cancer treatment space continue to expand, with new iterations of drug cocktails and viruses that can fight cancer cells emerging in the biotech space. Implants like the one developed by the Brigham and Women’s Hospital bring scientists one step closer to better being able to use tools and data to provide more personalized care treatment plans for cancer patients.

This article originally appeared on Engadget at https://www.engadget.com/an-experimental-rice-sized-implant-monitors-how-drugs-affect-tumors-210038580.html?src=rss

An experimental rice-sized implant monitors how drugs affect tumors

Researchers at Brigham and Women’s Hospital in Boston have developed an implant, notably as small as a grain of rice, that can test the effects of drugs on a patient’s brain tumor in real-time during surgery. Currently, monitoring the effects of drugs on a brain cancer patient during surgery is limited to intraoperative brain imaging and tissue sampling after a drug has been administered. The technique known as microdialysis currently stands as one of the more minimally invasive sampling options for testing the impact of drugs on brain tumors, but even that requires an entire catheter to be inserted into the patient’s skull cavity.

During development, researchers from Brigham and Women’s Hospital designed the device specifically to help test treatments in patients with brain cancers or gliomas, a type of tumor that originates in the brain or spinal cord. The device is designed to only remain implanted in a patient for about two to three hours while it delivers microdoses of the respective drug that is under observation. It can observe the impact of up to 20 drugs on the market for cancerous tumors, according to the researchers. Once the device is removed (sometime before the surgery ends), the surrounding tissue is returned to the lab for analysis.

In a statement published Wednesday, Pierpaolo Peruzzi, co-principal investigator and assistant professor in the Department of Neurosurgery at Brigham and Women’s Hospital said that knowing the impact of cancer drugs on these tumors is critical. “We need to be able to understand, early on, which drug works best for any given patient,” he said.

 Brigham and Women’s Hospital building pictured
Brigham and Women’s Hospital

During the development process, researchers at the Brigham and Women’s Hospital ran a clinical trial to observe the actual impact of the implant on real patients. The study found that none of the patients in the trial experienced any adverse effects. The researchers were able to collect biological data from the devices, such as what molecular changes happened when each drug was administered. While the study demonstrated that the implant could be easily incorporated into surgical practice, the researchers are still determining how the data it can gather should be used to optimize tumor therapy.

The researchers are now conducting another study that focuses on implanting the device through a minimally invasive procedure 72 hours before their main surgery. Advancements in the cancer treatment space continue to expand, with new iterations of drug cocktails and viruses that can fight cancer cells emerging in the biotech space. Implants like the one developed by the Brigham and Women’s Hospital bring scientists one step closer to better being able to use tools and data to provide more personalized care treatment plans for cancer patients.

This article originally appeared on Engadget at https://www.engadget.com/an-experimental-rice-sized-implant-monitors-how-drugs-affect-tumors-210038580.html?src=rss

Biometric implant monitors transplant patients for organ rejection

Researchers at Northwestern University developed a bioelectric implant that can detect temperature fluctuations that typically happen right before a body rejects an organ transplant. The sensor is smaller than a fingernail, and a mere 220 micrometers thick.

This new sensor technology is thin enough to sit directly on a kidney's fibrous layer — called the renal capsule — which surrounds and protects the organ. The device works by continuously monitoring changes to blood flow and temperature. The built-in thermometer can sense increases as minuscule as 0.004 degrees Celsius. Once an irregularity is detected, the sensor, which contains a micro coin cell battery for power, uses Bluetooth to alert a patient or physician via a smartphone or tablet. Any increase typically signals inflammation which is a potential sign of transplant rejection.

After any surgery that involves an organ transplant, the risk of rejection is high. The sensor was developed specifically for kidney transplants but it could also work for other organs, including the liver and lungs. Kidney transplants in the US are on the rise and are usually recommended for people who will not be able to live without dialysis. The American Kidney Fund cites that an acute rejection of a kidney transplant one month after surgery happens in about five to twenty percent of patients that go under.

That’s why it is critical to detect transplant rejection, which occurs when your body's immune system treats the new organ like a foreign object and attacks it. If a healthcare provider detects signs of rejection early enough, medical intervention can preserve the new organ in the new host. Northwestern researchers said that the device detected warning signs of organ rejection three weeks earlier than current monitoring methods. The current “gold standard” for detecting rejection is a biopsy, where a tissue sample is extracted from the transplanted organ and then analyzed in a lab. However, biopsies are invasive and can cause bleeding and increase the risk for infection.

An infrared camera glows red where the thermometer detects a subtle source of heat.
Northwestern University

Despite developing an innovative first-of-its-kind product, researchers at Northwestern University still have a long way to go. It still needs to be tested on humans in a clinical setting before it can make any impact in the surgical market. Northwestern’s John A. Rogers, a bioelectronics expert who led the device development, said in a statement that his team is now evaluating ways to recharge the coin cell battery so that it can last a lifetime.

This article originally appeared on Engadget at https://www.engadget.com/biometric-implant-monitors-transplant-patients-for-organ-rejection-180045215.html?src=rss

Biometric implant monitors transplant patients for organ rejection

Researchers at Northwestern University developed a bioelectric implant that can detect temperature fluctuations that typically happen right before a body rejects an organ transplant. The sensor is smaller than a fingernail, and a mere 220 micrometers thick.

This new sensor technology is thin enough to sit directly on a kidney's fibrous layer — called the renal capsule — which surrounds and protects the organ. The device works by continuously monitoring changes to blood flow and temperature. The built-in thermometer can sense increases as minuscule as 0.004 degrees Celsius. Once an irregularity is detected, the sensor, which contains a micro coin cell battery for power, uses Bluetooth to alert a patient or physician via a smartphone or tablet. Any increase typically signals inflammation which is a potential sign of transplant rejection.

After any surgery that involves an organ transplant, the risk of rejection is high. The sensor was developed specifically for kidney transplants but it could also work for other organs, including the liver and lungs. Kidney transplants in the US are on the rise and are usually recommended for people who will not be able to live without dialysis. The American Kidney Fund cites that an acute rejection of a kidney transplant one month after surgery happens in about five to twenty percent of patients that go under.

That’s why it is critical to detect transplant rejection, which occurs when your body's immune system treats the new organ like a foreign object and attacks it. If a healthcare provider detects signs of rejection early enough, medical intervention can preserve the new organ in the new host. Northwestern researchers said that the device detected warning signs of organ rejection three weeks earlier than current monitoring methods. The current “gold standard” for detecting rejection is a biopsy, where a tissue sample is extracted from the transplanted organ and then analyzed in a lab. However, biopsies are invasive and can cause bleeding and increase the risk for infection.

An infrared camera glows red where the thermometer detects a subtle source of heat.
Northwestern University

Despite developing an innovative first-of-its-kind product, researchers at Northwestern University still have a long way to go. It still needs to be tested on humans in a clinical setting before it can make any impact in the surgical market. Northwestern’s John A. Rogers, a bioelectronics expert who led the device development, said in a statement that his team is now evaluating ways to recharge the coin cell battery so that it can last a lifetime.

This article originally appeared on Engadget at https://www.engadget.com/biometric-implant-monitors-transplant-patients-for-organ-rejection-180045215.html?src=rss

Johnson & Johnson gets FDA approval for heart treatments that don’t require X-rays

Johnson & Johnson's Medical technology arm received FDA approval for a new workflow that will make it safer for medical professionals to treat atrial fibrillation, a condition that makes your heartbeat irregular and can cause stroke or heart failure. Several products developed by Biosense Webster, which is part of J&J MedTech, got the OK for a "zero fluoroscopy workflow" from the FDA, meaning live X-ray imaging will no longer be needed during catheter insertion procedures. Instead of using X-rays to insert Biosense catheters, medical professionals can now use ultrasound to guide treatments.

Using fewer X-rays, or fluoroscopy, lowers radiation exposure for both patients and medical professionals. Currently, doctors and medical staff who work in treatment rooms that specialize in treating relevant heart procedures often get too much exposure to radiation over time, which can lead to problems like eye issues, cancer, and bone injuries. This FDA approval helps address the recurring occupational hazard. Providers working in cath labs also won't have to wear heavy protective gear like lead aprons anymore when applying the newly approved workflow, reducing the risk of long-term muscle and bone pain.

This move by the FDA marks the first and only approval of its kind. The thumbs up was based on data from clinical trials and research from the REAL AF Registry, or the real-world evidence registry in the electrophysiology field. The data backed how well the treatment works in real-life situations. The new method will only apply for Biosense products like the THERMOCOOL SMARTTOUCH SF catheter, the most commonly used ablation catheter, among others.

This article originally appeared on Engadget at https://www.engadget.com/johnson--johnson-gets-fda-approval-for-heart-treatments-that-dont-require-x-rays-150913343.html?src=rss

Johnson & Johnson gets FDA approval for heart treatments that don’t require X-rays

Johnson & Johnson's Medical technology arm received FDA approval for a new workflow that will make it safer for medical professionals to treat atrial fibrillation, a condition that makes your heartbeat irregular and can cause stroke or heart failure. Several products developed by Biosense Webster, which is part of J&J MedTech, got the OK for a "zero fluoroscopy workflow" from the FDA, meaning live X-ray imaging will no longer be needed during catheter insertion procedures. Instead of using X-rays to insert Biosense catheters, medical professionals can now use ultrasound to guide treatments.

Using fewer X-rays, or fluoroscopy, lowers radiation exposure for both patients and medical professionals. Currently, doctors and medical staff who work in treatment rooms that specialize in treating relevant heart procedures often get too much exposure to radiation over time, which can lead to problems like eye issues, cancer, and bone injuries. This FDA approval helps address the recurring occupational hazard. Providers working in cath labs also won't have to wear heavy protective gear like lead aprons anymore when applying the newly approved workflow, reducing the risk of long-term muscle and bone pain.

This move by the FDA marks the first and only approval of its kind. The thumbs up was based on data from clinical trials and research from the REAL AF Registry, or the real-world evidence registry in the electrophysiology field. The data backed how well the treatment works in real-life situations. The new method will only apply for Biosense products like the THERMOCOOL SMARTTOUCH SF catheter, the most commonly used ablation catheter, among others.

This article originally appeared on Engadget at https://www.engadget.com/johnson--johnson-gets-fda-approval-for-heart-treatments-that-dont-require-x-rays-150913343.html?src=rss

Why are non-diabetics suddenly wearing continuous glucose monitors?

“Let’s see what a Snickers bar does to my blood sugar,” Justin Richard, a 52-year-old Toronto-based TikToker says just before eating the candy bar on camera. After an edited time skip, Richard says, “It’s been several hours since I’ve had the chocolate bar, let’s have a look at the glucose monitor and see what actually happened.” He slightly lifts his arm flashing the device, an inconspicuous blue circular patch that almost looks like a Band-Aid. Above his head flashes a screenshot of his blood glucose reading, which appears to have spiked, dipped, and spiked again. “I had a spike in my blood sugar,” he says. “That's not a shock because this is loaded with sugar.” A red ‘X’ graphic appears over some b-roll of the Snickers bar. “I did this test because I’m trying to establish a benchmark.”

This is a typical 60-second TikTok from Richard, whose handle is @insulinresistant1 on the platform. In the following clip, Richard eats a cup of broccoli before eating another full Snickers bar, then goes on to share the results of his blood glucose levels from his personal continuous glucose monitor. He eats this oddball combination to show how variations in his food intake can impact or even prevent a blood glucose spike.

Continuous glucose monitors (or CGMs) have long been used as a tool to track blood sugar levels for people with Type 1 and Type 2 diabetes. Here’s the thing, though: Richard does not have diabetes.

While monitoring sugar intake is standard practice for people on tight blood sugar control treatment plans and those with persistently low blood glucose levels, modern CGM devices – non-invasive wearables that can attach to the back of an arm for weeks at a time – have become a popular wellness trend on social media. Users like Richard that have integrated a CGM into their daily life have stormed platforms like TikTok and Instagram. Some internet health coaches and dieticians have trumpeted their praise. On TikTok, the hashtags #insulinresistance has 1.2 billion views, while #continuousglucosemonitor has over 32.7 million views. Richard, who has over 800,000 TikTok followers, is just one influencer who helped fuel this trend. On his page, which he started during the pandemic, showcases him eating a wide range of foods and drinks, from sodas to chocolate bars, reacting to readings emitting from his Signos-sponsored CGM device.

Richard says he got into continuous glucose monitoring to “optimize his health” and prevent chronic illness, which was especially important to him considering his extensive family history of Type 2 diabetes. “It's like having a coach,” he said in an interview. “But the coach is telling you to do something.” That something was to make some pretty dramatic dietary changes. “'I'm not a healthcare professional and I don't pretend to be. All of my tests are about my blood sugar, and what I read online and how it affects me,” he said, adding that his disclaimer that “individual results will vary” is a key part of his messaging.

NEW YORK, NEW YORK - MARCH 02: Taylor Jane Stimmler, whose had type 1 diabetes since she was a teenager, displays her continuous glucose monitor she wears on her arm on March 02, 2023 in New York City. Drugmaker Eli Lilly announced yesterday that it will cap the out-of-pocket cost of its insulin at $35 a month. Medical experts believe that the unexpected move may compel other insulin makers in the U.S. to follow suit and cap their prices of insulin. For those without health insurance or a health plan, the cost of insulin can cost hundreds or thousands of dollars a month for a diabetic. (Photo by Spencer Platt/Getty Images)
Getty Images

Blood glucose monitoring devices are not new. In the late 1990s, medical companies like Medtronic, Dexcom and Abbott revolutionized the way diabetes could be managed. The importance of continuous glucose monitoring for patients is well established as a means of improving glycemic control, especially in the case of Type 1 diabetes.

CGMs are a vital tool for preventing diabetic ketoacidosis, a life-threatening complication seen in Type 1 diabetic patients. When sugar levels are too high and the body begins to break down fat as fuel, it can lead to a high amount of acid circulation in the bloodstream. For non-diabetics, however, complications stemming from extremely high or low blood sugar levels isn’t a concern. There is little to no research to back that monitoring blood glucose levels in generally healthy adults equates to an overall improvement in health. 

Man putting new sensor on the back of upper arm
Getty Images

Dr. Idz, another TikToker with over 1.7 million followers, calls the use of CGM devices for adults without any prescribed medical need a “feature of disordered eating.” Dr. Idz, short for Idrees Mughal, is a board-certified UK-trained medical doctor with expertise in nutritional research. He became a prominent figure when he started rebuking the “nonsense health information” circulating on TikTok that “prey[s] on people's vulnerabilities.” He says CGMs aren’t really intended for non-diabetics because “our body is designed to regulate the spike.” Dr. Idz says people need to understand that spiking blood glucose is not a problem. In fact, that is supposed to happen when you eat food. Even eating protein can spike your insulin levels. This is important because people are scared of blood glucose spikes because it "spikes your insulin" and they think that causes fat gain and insulin resistance, Dr. Idz explains. "But no one really hypes on about that, right?"

Although there may not be an inherent physical risk for people who wear a CGM device to monitor and track sugar levels, there is a real possibility that access to “too much data” can lead to information overload, false alarms, unnecessary anxiety, confusion or misinterpretation. Slight fluctuations in blood sugar levels are normal in people who don’t have diabetes. Dr. Robert Shmerling, a senior faculty editor for Harvard Health Publishing and author of “Is blood sugar monitoring without diabetes worthwhile?” writes that, “we're at the very beginning of the learning curve for home monitoring of blood sugar in people without diabetes. Before buying into what may be the next fad in health monitoring, I think we need to learn a lot more.”

Still, it’s no surprise that more people are interested in experimenting with CGM devices. Not only are TikTokers promoting blood glucose monitoring as an indicator of health and wellness, but ads for CGM devices from up-and-coming brands like Nutrisense, Veri and Signos have been flooding social media.

The companies use language designed to sell the average person on the importance of regularly tracking blood sugar levels as a way to lose weight or as a “metabolism hack.” The idea is that eating refined carbs and sugary foods can spike blood glucose levels and, over time, the cells that are supposed to take up insulin and regulate glucose production in the liver become resistant to the hormone due to habitual bad dieting. Heather Davis, a registered and licensed dietitian and nutritionist at Nutrisense denies that the company promises weight loss through glucose monitoring. “A CGM is not a weight loss device per se,” she said. “The CGM is simply one tool among many that may support insights into how different dietary and lifestyle approaches influence metabolic health, including weight factors.”

The needle of a glucose sensor in the insertion device
Getty Images/iStockphoto

Dr. Idz would disagree with Nutrisense on that. He argues that the vast majority of people won't even know how to interpret CGM results. “Even me as a medical doctor, I would probably need to look at some reference values for each individual, you know, perhaps have to do some calculations. And that's me who's actually a medical doctor. Imagine the average person who's just going, ‘oh, my gosh, I've had a spike. That must mean it's bad, right?’ You don't even know how to interpret it. So it's going to be completely useless.”

Nutrisense’s Davis concedes that there is limited research currently looking at CGM use in non-diabetic populations, but she argues that “once upon a time, there was also limited research looking at CGM use in diabetic populations” and that the “risks of wearing a CGM are extremely minimal for most people.” Still, the FDA has never recommended continuous glucose monitoring for healthy individuals. It has only even approved a handful of devices for people who do suffer from diabetes. Although it may be useful for predicting a risk for pre-diabetes and diabetes, there is a consensus that more scientific studies are needed to observe CGM use among healthy populations.

Companies marketing their wearables to healthy people are entering a crowded, but growing market that’s ripe for exploitation. There is arguably an enormous opportunity for companies advertising to healthy individuals to reap financial benefits from the latest health fad.

A rendering of a smartphone with the Signos CGM app, along with an Apple Watch and the arm applique for this Insulin tracking tool.
Signos

TikToker Richard says he thinks continuous glucose monitoring is only going to grow from here. “I don't think this trend is going to end anytime soon,” he said. “Anybody and every country that's adopted this fast food, highly processed diet is having this same increase in Type 2 diabetes and you really can't ignore it. So I think this trend is gonna continue as long as this fast food is so prevalent.” Dr. Idz, on the other hand, would argue that if you want to prevent diabetes, “that's fine but you're not going to do it by wearing a CGM because you know, as long as you're not insulin resistant, you'll find that you don't need a CGM."

To make matters worse, not only are CGMs questionably useful for healthy individuals, but they can be expensive, too. The devices must be replaced every seven to 14 days depending on the manufacturer. Nutrisense does not accept insurance coverage on the grounds it is a “wellness program,” with monthly subscriptions starting at $225 and no-commitment plans reaching $399 a month. Competitors like Signos, which accepts insurance with a diabetes diagnosis, offers a monthly plan for its wearable and monitoring app, and that costs upwards of $449 a month. Veri may accept insurance, depending on the provider. And even though it’s able to dramatically undercut its competitors, the monthly fee of between $40 to $109 is hardly cheap. Richard, who has historically paid out of pocket for his CGM devices, believes the high cost is going to “save him money in the long run.”

Unfortunately, these lofty prices don’t just affect health-conscious TikTokers. Access to CGM devices for diabetic populations can be spotty. Individuals covered by Medicaid are less likely to have one covered, especially people of color, according to the American Diabetes Association (ADA).

Aside from the technology’s often inaccessible price points, some experts argue that there simply isn't enough guidance from the scientific community on CGM applications for healthy individuals. The ADA does not recommend CGM device use by healthy people, only clearly stating that the technology should be considered “from the outset of the diagnosis of diabetes that requires insulin management.”

Dr. Idz takes this a step further, stating flatly that “there is no evidence whatsoever that blunting blood sugar spikes does anything for our health.” He backs up his argument with research from a retrospective and randomized trial that focused on the impact of blood glucose monitoring in diabetic and non-diabetic populations. Dr. Idz says, if anything, research suggests that a low average blood glucose level is bad for you and might increase mortality risk over time due to diminished consumption of healthy nutrients and decreased liver function.

Harvard’s Dr. Shmerling reports he could not find a published study suggesting that monitoring blood glucose levels directly translated into improved health. “Unfortunately, some makers of CGM systems aren't waiting for solid research results to market these devices to healthy people. So, consumers and marketing professionals — not researchers or doctors — may wind up driving demand for the product,” Dr. Shmerling writes. Despite the lacking body of evidence to support blood glucose monitoring among healthy populations, the inflated price points for direct to consumer products, and the technological handicaps still present in the burgeoning industry, the growing popularity of CGMs among health and fitness enthusiasts does not seem to be slowing down.

Update, July 18th 2023, 2:17 PM ET: This story has been updated to clarify that Dr. Idz had mistakenly said glucose when he meant insulin.

This article originally appeared on Engadget at https://www.engadget.com/why-are-non-diabetics-suddenly-wearing-continuous-glucose-monitors-161506594.html?src=rss

The first drug that slows Alzheimer’s has finally received FDA approval

Japanese drugmaker Eisai and US-based Biogen have been working together on advancing research in the space of Alzheimer’s for nearly a decade. Finally, the FDA, granted the fruits of that labor, Leqembi, its blessing for intravenous use. This marks the first approved treatment that can slow the progression of Alzheimer’s.

Leqembi received a preliminary approval in January that allowed it to be used in a limited capacity. That approval was conditioned on the two drug makers conducting a confirmatory study to verify the drug's clinical benefit.

Though Leqembi slows Alzihmer’s progression, it is not a cure. Instead, it addresses the underlying biology that spurs Alzheimer's advancement. The drug works by reducing amyloid plaques, or "misfolded" proteins that form in the brain of a person with Alzheimer's. 

Leqembi isn’t the only drug targeting beta-amyloid plaque buildup to treat Alzheimer's. Aduhelm received approval under the same accelerated pathway in 2021, but it’s still not fully FDA-approved. But what sets Leqembi apart from its predecessor is that the drug demonstrated actual clinical benefit in addition to simply reducing the buildup of the aforementioned proteins.

Besides needing a medical prescription, taking the drug will require professional administration in a hospital or infusion center every two weeks. The company, though it may not be its sole responsibility, recognizes its need to boost accessibility. In a public statement, Christopher Viehbacher, the CEO of Biogen, said the company’s main focus now is to work with Eisai to make Leqembi “accessible to eligible patients as soon as possible.”

The drug’s hefty price tag of $26,500 will unfortunately make it inaccessible to most. Current rules mean that it’s unlikely to be covered by Medicare. According to the Alzheimer's Association, those on Medicaid only should be able to get coverage of the FDA-approved drug in most cases. But, even if Medicaid does cover it, patients would be responsible for a 20 percent copay – or about $5,300. Experts predict the total cost of Leqembi treatment can run upward of $90,000 a year, if you take infusions and laboratory tests into account.

An expensive treatment program is something to consider for the one in nine Americans who are over the age of 65 that have Alzheimer’s dementia. That number is expected to grow as the nation’s aging population continues to grow. The number of Americans 65 and older is projected to climb from 58 million in 2021 to 88 million by 2050. This has led to an increased focus on treatments and diagnostics for Alzheimer’s, like blood tests that can detect the disease.

This article originally appeared on Engadget at https://www.engadget.com/the-first-drug-that-slows-alzheimers-has-finally-received-fda-approval-165058452.html?src=rss

Scientists have successfully engineered bacteria to fight cancer in mice

Researchers at Stanford Medicine have made a promising discovery that could lead to new cancer treatments in the future. Scientists conducted tests in which they altered the genomes of skin-based microbes and bacteria to fight cancer. These altered microbes were swabbed onto cancer-stricken mice and, lo and behold, tumors began to dissipate.

The bacteria in question, Staphylococcus epidermidis, was grabbed from the fur of mice and altered to produce a protein that stimulates the immune system with regard to specific tumors. The experiment seemed to be a resounding success, with the modified bacteria killing aggressive types of metastatic skin cancer after being gently applied to the fur. The results were also achieved without any noticeable inflammation.

“It seemed almost like magic,” said Michael Fischbach, PhD, an associate professor of bioengineering at Stanford. “These mice had very aggressive tumors growing on their flank, and we gave them a gentle treatment where we simply took a swab of bacteria and rubbed it on the fur of their heads.”

This is yet another foray into the misunderstood world of microbiomes and all of the bacteria that reside there. Gut biomes get all of the press these days, but the skin also plays host to millions upon millions of bacteria, fungi and viruses, and the purpose of these entities is often unknown.

In this instance, scientists found that staph epidermidis cells trigger the production of immune cells called CD8 T cells. The researchers basically hijacked the S. epidermidis into producing CD8 T cells that target specific antigens. In this case, the antigens were related to skin cancer tumors. When the cells encountered a matching tumor, they began to rapidly reproduce and shrink the mass, or extinguish it entirely.

“Watching those tumors disappear — especially at a site distant from where we applied the bacteria — was shocking,” Fischbach said. “It took us a while to believe it was happening.”

As with all burgeoning cancer treatments, there are some heavy caveats. First of all, these experiments are being conducted on mice. Humans and mice are biologically similar in many respects, but a great many treatments that work on mice are a dud with people. Stanford researchers have no idea if S. epidermidis triggers an immune response in humans, though our skin is littered with the stuff, so they may need to find a different microbe to alter. Also, this treatment is designed to treat skin cancer tumors and is applied topically. It remains to be seen if the benefits carry over to internal cancers.

With that said, the Stanford team says they expect human trials to start within the next few years, though more testing is needed on both mice and other animals before going ahead with people. Scientists hope that this treatment could eventually be pointed at all kinds of infectious diseases, in addition to cancer cells.

This article originally appeared on Engadget at https://www.engadget.com/scientists-have-successfully-engineered-bacteria-to-fight-cancer-in-mice-165141857.html?src=rss