Health

Alzheimer’s experimental drug may slow progression of disease, but there are risks: experts

Published

1 year ago

December 3, 2022

Alzheimer’s experimental drug may slow progression of disease, but there are risks: experts

The experimental drug lecanemab has indicated a slowing of cognitive decline development by 27% in sufferers with early-stage Alzheimer’s, based on a examine revealed this week within the New England Journal of Medication.

“These findings present that lecanemab gives promise for folks with early Alzheimer’s illness, with a major slowing of decline and an inexpensive security profile,” the examine’s lead researcher, Dr. Christopher H. Van Dyck, informed Fox Information Digital in an interview.

Van Dyck is director of the Alzheimer’s Illness Analysis Unit and a professor of psychiatry, neurology and neuroscience on the Yale College College of Medication.

ALZHEIMER’S DRUG STUDY YIELDS POSITIVE RESULTS IN EARLY STAGES OF DISEASE

Within the examine, Van Dyck’s researchers stated the drug lecanemab “diminished markers of amyloid in early Alzheimer’s illness and resulted in reasonably much less decline on measures of cognition and performance than placebo at 18 months — however was related to antagonistic occasions.”

On this Might 19, 2015, file picture, a health care provider factors to PET scan outcomes which are a part of a examine on Alzheimer’s illness at a hospital in Washington. Scientists know that lengthy earlier than the reminiscence issues of Alzheimer’s turn out to be apparent, folks expertise extra delicate modifications of their considering and judgment.
(AP Picture/Evan Vucci)

Pharmaceutical corporations Eisai Co. Ltd. and Biogen Inc., developed the drug.

The drug is a monoclonal antibody — it interferes with the formation of amyloid plaque, thought-about a significant offender in Alzheimer’s illness, based on specialists.

‘Related to much less medical decline’

The examine included 1,795 members who had early Alzheimer’s illness.

Of the members, 898 acquired lecanemab, whereas 897 acquired a placebo in 235 websites positioned in North America, Asia and Europe from March 2019 to March 2021, based on the examine.

NOSE PICKING WAS ALWAYS GROSS — NOW A STUDY SAYS IT MAY LEAD TO LATE-ONSET ALZHEIMER’S

The members got lecanemab intravenously each two weeks over an 18-month interval.

“Analyses at 18 months confirmed dose- and time-dependent clearance of amyloid with lecanemab, and the drug was related to much less medical decline on some measures than placebo,” the researchers stated within the revealed examine.

The lecanemab group mirrored slower development in cognitive decline.

The investigators relied on a software that measures cognitive impairment. It is referred to as the Medical Dementia Score-Sum of Packing containers (CDR-SB) — it follows the members’ progress.

The common baseline scores had been roughly 3.2 in each the lecanemab and placebo teams. A rating of 0.5 to six is in line with early Alzheimer’s illness, based on the researchers.

The headquarters of Biogen Inc. are shown in March 2020 in Cambridge, Massachusetts. Together with Eisai Co. Ltd., Biogen developed the new drug.

The headquarters of Biogen Inc. are proven in March 2020 in Cambridge, Massachusetts. Along with Eisai Co. Ltd., Biogen developed the brand new drug.
(AP Picture/Steven Senne, File)

After 18 months of remedy, the typical rating of the lecanemab group went up by 1.21 factors, in comparison with sufferers within the placebo group — who noticed their rating go up by 1.66 factors.

The lecanemab group mirrored slower development in cognitive decline.

Some members did expertise antagonistic occasions, the researchers famous.

NEW STUDY INDICATES DEMENTIA SIGNS CAN BE DETECTED NEARLY A DECADE BEFORE DIAGNOSIS

Roughly 20% of sufferers receiving lecanemab skilled mind swelling or mind bleeding, based on the examine.

Lecanemab is up for FDA approval in early 2023.

Eisai stated two deaths occurred, although they weren’t thought-about linked to lecanemab.

Officers on the Alzheimer’s Discovery Drug Basis (ADDF) stated in a launched assertion that lecanemab, which is up for FDA approval in early 2023, represents a optimistic step towards remedy of the illness and “welcomed information for the thousands and thousands of sufferers and households residing with Alzheimer’s.”

Said one leading expert in Alzheimer's about the new findings, "We have a lot of ground to cover to get from the 27% slowing [that] lecanemab offers to our goal of slowing cognitive decline by 100%."

Stated one main knowledgeable in Alzheimer’s in regards to the new findings, “We’ve a whole lot of floor to cowl to get from the 27% slowing [that] lecanemab gives to our aim of slowing cognitive decline by 100%.”
(iStock)

Dr. Howard Fillit, co-founder and chief science officer on the ADDF, additionally stated within the assertion, “However that is solely a begin to stopping Alzheimer’s in its tracks. We’ve a whole lot of floor to cowl to get from the 27% slowing [that] lecanemab gives to our aim of slowing cognitive decline by 100%.”

The ADDF assertion stated amyloid-clearing medicine are a part of the answer in addressing Alzheimer’s illness.

COGNITIVE DECLINE CAN BE AVOIDED WITH SIMPLE, EVERYDAY EXERCISES, NEW STUDY SUGGESTS

But additional improvement is required of a brand new era of medicines that may goal particular pathologies that contribute to the illness.

The Alzheimer’s Affiliation stated it was inspired by the worldwide medical trial of lecanemab.

“Distinctive drug combos matched to every affected person’s underlying pathologies is the reply and our greatest hope to offer sufferers long-lasting reduction from this insidious and progressive illness,” Fillit stated within the launched assertion.

The Alzheimer’s Affiliation additionally launched a press release concerning the part three-trial outcomes.

One expert who was not involved in the study told Fox News Digital she was excited to see the statistically significant difference between the lecanemab and placebo groups in the study — but cautioned that more research on the Alzheimer's drug is needed.

One knowledgeable who was not concerned within the examine informed Fox Information Digital she was excited to see the statistically vital distinction between the lecanemab and placebo teams within the examine — however cautioned that extra analysis on the Alzheimer’s drug is required.
(iStock)

On its web site, the group stated it was inspired by the worldwide medical trial of lecanemab.

It stated the examine “confirms this remedy can meaningfully change the course of the illness for folks within the earliest levels of Alzheimer’s illness. The Alzheimer’s Affiliation requires the Meals and Drug Administration’s accelerated approval of lecanemab.”

The group additionally famous, partially, “These peer-reviewed, revealed outcomes present lecanemab will present sufferers extra time to take part in each day life and dwell independently. It may imply many months extra of recognizing their partner, kids and grandchildren.”

“Statistically vital doesn’t all the time imply virtually vital, particularly not within the setting of great dangers.”

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Dr. Marzena Gieniusz, medical program director of the Alzheimer’s and Dementia Care (ADC) Program at Northwell Well being on Lengthy Island, New York, commented on the findings.

Dr. Gieniusz, who was not concerned within the examine, stated she was excited to see the statistically vital distinction between the lecanemab and placebo teams within the examine — however cautioned that extra analysis on the drug is required.

“Statistically vital doesn’t all the time imply virtually vital, particularly not within the setting of great dangers, which had been famous within the examine, in addition to the dangers not but evident — together with the potential for elevated hospitalizations, pointless interventions, and so on.”

"The FDA is expected to decide whether to grant accelerated approval to lecanemab by January 6, 2023," said the Alzheimer's Association.

“The FDA is predicted to determine whether or not to grant accelerated approval to lecanemab by January 6, 2023,” stated the Alzheimer’s Affiliation.
(iStock)

Gieniusz additionally informed Fox Information Digital, “Though I’m glad to see the outcomes to date, I’m wanting to be taught extra, together with in regards to the security and efficacy, earlier than meaningfully exploring and contemplating the sensible dangers, advantages and options of this drug.”

DRINKING COFFEE, TEA CAN LOWER THE RISK OF DEMENTIA, STROKE: STUDY

Van Dyck of the Alzheimer’s Illness Analysis Unit informed Fox Information Digital that additional analysis is presently underway — and that researchers want members.

“The subsequent steps in our analysis of this remedy will definitely be to go nonetheless earlier to asymptomatic, at-risk people.” (The trial in preclinical Alzheimer’s illness has been underway since 2019, however is behind in enrollment.)

Van Dyck stated he’s “optimistic” that the “outcomes will spur curiosity and enrollment and permit us to finish that essential examine.”

Van Dyck additionally stated he’s “optimistic” that the “outcomes will spur curiosity and enrollment and permit us to finish that essential examine. Along with the essential results in early symptomatic AD, we wish to know if that may be considerably enlarged by treating people earlier than a lot injury happens and vital signs start.”

Additionally, based on the Alzheimer’s Affiliation, there is a potential pricey drawback as a result of a Facilities for Medicare and Medicaid Companies (CMS) coverage that might block entry to the remedy if the FDA approves it.

“The FDA is predicted to determine whether or not to grant accelerated approval to lecanemab by January 6, 2023,” the affiliation stated.

“Ought to the FDA achieve this, the present CMS coverage will stop 1000’s and 1000’s of Medicare beneficiaries with a terminal, progressive illness from accessing this remedy throughout the restricted span of time they should entry it.”

The affiliation stated CMS pledged to maneuver shortly to change the coverage if new proof was introduced.

Now, given the brand new proof, “CMS can start its evaluation instantly,” the related stated. “The Alzheimer’s Affiliation calls on CMS to revise its coverage with the utmost urgency.”

Amy McGorry is a contributing well being reporter for Fox Information Digital. Comply with her on Twitter @amymcgorry.

Health

CDC, WebMD give update on current bird flu outbreak: ‘Be alert, not alarmed’

Published

6 hours ago

May 16, 2024

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CDC, WebMD give update on current bird flu outbreak: ‘Be alert, not alarmed’

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As bird flu continues to spread among cattle in the U.S., WebMD and the Centers for Disease Control and Prevention (CDC) joined forces on Thursday to present a live-streamed briefing on the status of the outbreak.

The presentation, called “WebMD and CDC Presents, 2024 Bird Flu: What You Need to Know,” was moderated by Neha Pathak, M.D., chief physician editor for WebMD in Atlanta, Georgia.

The first reports of sick dairy cows came to the USDA in early March, according to Eric Deeble, deputy assistant secretary for the Office of Congressional Relations at the United States Department of Agriculture (USDA) in Washington, D.C.

AMID BIRD FLU SPREAD, EXPERTS REVEAL IF IT’S SAFE TO DRINK MILK

Testing revealed that the cows had contracted H5N1, more commonly known as avian influenza, or bird flu.

“Any new disease of cattle is a great concern to us,” Deeble said during the briefing.

As bird flu continues to spread among cattle in the U.S., WebMD and the CDC issued an update on Thursday. (Getty Images)

“The H5N1 in cattle is a relatively mild disease. They generally recover after supportive care” within two to three weeks, he said.

“Their milk volume returns to normal, and they appear healthy and continue to feed as they did before they became sick.”

“Any new disease of cattle is a great concern to us.”

So far, the USDA has detected H5N1 in 49 dairy herds in nine states, Deeble stated.

“To put that into perspective, that’s around 1% of dairy farms in the affected states and about 1/10th of 1% nationally,” he said.

On April 29, a federal order from the USDA took effect, limiting the movement of lactating dairy cattle in an effort to monitor and compile H5N1 test results.

TEXAS CATS DIE ON DAIRY FARM AFTER DRINKING RAW MILK CONTAMINATED WITH BIRD FLU, CDC WARNS

“Under this order, dairy farmers are required to test their cows before moving them across state lines so that we know those cows are H5N1-free and don’t pose a risk to any new herd,” Deeble said.

The order also requires that any test results that detect the presence of H5N1 are reported to USDA labs.

No current food risk, experts say

Deeble assured those tuning in on Thursday that there is no risk with consuming milk and meat.

“I can say without reservation that our commercial milk and meat supplies are safe,” he said. “At no time were animals that are sick from H5N1 or any other animal disease permitted to enter into our food supply.”

He added, “USDA has never detected H5N1 in meat sold at retail.”

The first reports of sick dairy cows came to the USDA in early March, health officials said. (iStock)

Tests have confirmed that cooking meat to an internal temperature of 155 or above is sufficient to eliminate all traces of the virus, Deeble noted.

For milk, the pasteurization process ensures it is safe to drink, he said.

“Our milk is cleared to a high temperature for a brief period of time, inactivating H5N1, as well as other bacteria and viruses that could make someone sick,” he said.

Risk of transmission to humans

The overall risk to the public from bird flu is low, according to Dr. Nirav D. Shah, M.D., principal deputy director of the CDC in Atlanta.

“That is in part because it’s rare for people to get infected with bird flu viruses — but it has happened,” he said during the briefing.

“If and when it does happen, it’s most often through direct unprotected contact with infected animals — for example, not wearing gloves, face masks or eye protection.”

COULD A BIRD FLU PANDEMIC SPREAD TO HUMANS? HERE’S WHAT YOU NEED TO KNOW

In April, the CDC reported one human case of bird flu in a dairy worker in Texas, Shah said.

“This person’s only symptom was eye redness, or conjunctivitis,” he said. “After testing positive, this person was provided [with] an antiviral medicine and thankfully made a full recovery. There have been no new or additional human cases since this individual in Texas.”

Other symptoms to watch for include cough, fever, muscle aches and fatigue, according to Shah.

Experts said there is no risk associated with drinking milk purchased commercially. (iStock)

Although the overall risk to humans is low, the CDC is taking “aggressive steps” to make sure Americans stay well and informed, Shah said.

“Right now, one of our top areas of focus is around farm worker safety and protection — specifically making sure that workers have access to personal protective equipment … like gloves, goggles or face masks, which can help reduce their risk of exposure if they happen to be working around affected cows.”

MAINE WILDLIFE AUTHORITIES FIND 6 DEAD WILD DUCKS THAT TESTED POSITIVE FOR BIRD FLU

The CDC is also working with local health departments to ensure that sick farmers are tested for bird flu and to monitor their status.

“In addition to that, scientists in our laboratories here at CDC are looking closely at the bird flu viruses to see if there are any changes in their DNA that might tell us if these viruses are able to spread more easily to people, between people, and, importantly, whether they might be causing more serious illness,” Shah added.

Although the overall risk to humans is low, the CDC is taking “aggressive steps” to make sure Americans stay well and informed, a doctor said. (REUTERS/Dado Ruvic/Illustration/File Photo)

Although the risk to the public “remains low” currently, the doctor offered guidance for certain groups that may be at a higher risk.

“If you happen to work around animals, whether it’s chickens, whether it’s cattle, or whether it’s pigs, and you develop signs and symptoms that might otherwise be the flu, it’s important to make sure you call a health care provider and have a conversation with them.”

Not another COVID, experts say

The current situation with bird flu is different from the early days of COVID-19, Shah said during the briefing.

“We are in a much different place because of over two decades of investment in planning and preparing for things like influenza,” he said.

CDC WARNS OF INVASIVE BACTERIAL OUTBREAK AMID SPIKE IN CASES AND FATALITY RATES: ‘RARE BUT SEVERE’

“As a result of that extensive planning and preparedness, there are medicines in place.”

If those medications are given early, they can reduce the severity and duration of illness, as was the case with the farmer in Texas, Shah noted.

“This is just one of many ways in which … influenza and bird flu differs from what many of us remember from four years ago,” he added.

Vaccines and prevention

The traditional influenza vaccine doesn’t provide much protection against avian flu, the experts noted.

“Even though they are … basically the same virus, they differ just enough to where the flu shot — which we hope everyone gets — doesn’t do a great job at protecting you,” said Shah.

“It might do a little bit of work, but it’s not enough to take you to the bank.”

“We’re not at a spot where vaccination is recommended for anyone,” a doctor said in the briefing on Thursday. (Julian Stratenschulte/dpa)

David Boucher, PhD, director of Infectious Diseases Preparedness and Response at ASPR in Washington, D.C., spoke during the Thursday briefing about the potential need for a bird flu vaccine.

“We’re not at a spot where vaccination is recommended for anyone,” he said.

Through the National Influenza Vaccine Program, the ASPR works with health partners to identify influenza viruses that are “just a little bit different from the things that we’ve seen in the past,” Boucher said.

WITH WHOOPING COUGH CASES ON THE RISE, DO YOU NEED A BOOSTER VACCINE?

For a novel virus, the team develops “building blocks” of a vaccine, he noted.

“The good news here is that this system has worked the way we hoped it would, and we have an initial supply of the building blocks we would need if we needed vaccines for the [H5N1] virus,” he said.

To monitor potential spread, the CDC is on the lookout for an increase in emergency department visits or laboratory tests that might signal a “cluster of cases,” a doctor said. (REUTERS/Dado Ruvic/Illustration)

In that scenario, Boucher said, the ASPR could partner with manufacturers of seasonal influenza vaccines for “large-scale” production.

Boucher also emphasized the importance of personal protective equipment (PPE) — such as gloves, goggles, face shields and N95 masks — for agricultural workers who may be close to infected animals.

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To monitor potential spread, the CDC is on the lookout for an increase in emergency department visits or laboratory tests that might signal a “cluster of cases,” Shah said.

“We’re also more recently looking at wastewater to see if there are changes there,” he said.

People can stay up to date on the latest bird flu developments from the CDC, the USDA, the FDA and other trusted sources of information, Shah added.

“We should be alert, not alarmed.”

For more Health articles, visit www.foxnews.com/health.

Health

The Atkins Diet: Behind the Staple Weight Loss Plan | Woman's World

Published

13 hours ago

May 16, 2024

Press Room

The Atkins Diet: Behind the Staple Weight Loss Plan | Woman’s World

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Health

A cancer patient's second chance at motherhood, plus a pastor's journey through depression

Published

13 hours ago

May 16, 2024

Press Room

A cancer patient's second chance at motherhood, plus a pastor's journey through depression

Kelly Spill of New Jersey was a new mom with a 1-month-old son (shown at left) when she was diagnosed with stage 3 colorectal cancer. (Kelly Spill)

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NATURE’S MEDICINE – An orangutan healed its own wound using medicinal leaves found in the wild. See the amazing photos. Continue reading…

An orangutan that sustained a facial wound, shown on the left, treated it himself, according to a study published in the journal Scientific Reports earlier this month. In the image on the right, his scar is just barely noticeable. (Armas Fitra & Safruddin & TNGL & KLHK & MPI & UNAS & YEL)