Tag Archives: Alzheimer’s

U.S. experts to review Biogen drug that could be first new Alzheimer’s treatment in decades

By Deena Beasley

(Reuters) – U.S. health experts this week will decide whether to recommend approval for Biogen Inc’s Alzheimer’s drug, which could become the first new treatment for the mind-wasting disease in decades even as serious questions persist over whether data show if it works.

In a field littered with unrelenting failure, Biogen believes in aducanumab it has the first drug that can treat an underlying cause, and therefore slow progression, of Alzheimer’s. But its path to approval has been anything but smooth or assured.

Biogen abruptly ended clinical trials of aducanumab last year after an early look at trial results showed it was not effective. Last October, the company shocked many Alzheimer’s experts by reversing course, saying that a new analysis showed aducanumab could help patients with early-stage disease preserve their ability to function independently for longer. In July, Biogen filed for approval from the Food and Drug Administration.

Now the agency faces tremendous pressure to approve a treatment option for millions of Americans suffering from Alzheimer’s and the millions more expected to face it in coming years.

Patient advocates say the need for a new Alzheimer’s treatment that could help people remain independent is heightened by the coronavirus pandemic, which has killed more than 229,000 people in the United States, including tens of thousands of seniors in nursing homes.

“The pandemic came and it changed everything,” said Russ Paulsen, chief operating officer at patient advocacy group UsAgainstAlzheimer’s. “We need something to keep people out of nursing homes.”

A committee of outside advisers to the FDA will discuss aducanumab on Nov. 6. The agency’s final decision is expected by March. European health regulators have also accepted the drug for review.

Charles Flagg, a 79-year-old retired minister from Jamestown, Rhode Island, had been enrolled for years in a trial of aducanumab before it was stopped. He started receiving the drug again in August as part of a follow-up study, according to his wife Cynthia Flagg.

“He’s not 100 percent himself, but overall I’m not dealing with someone that needs to be led around or be in a care home,” Flagg said.

Aducanumab, an antibody designed to remove amyloid plaques from the brain – a strategy tried with many failed Alzheimer’s drugs – would reap billions of dollars in sales if approved.

Biogen, along with partner Eisai Co Ltd <4523.T>, is one of the last large drugmakers pursuing treatments for a disease that afflicts nearly 6 million Americans and millions more worldwide. Biogen estimates about 1.5 million people with early Alzheimer’s in the United States could be candidates for the drug.

‘CLINICALLY MEANINGFUL’

Late last year, Biogen said one of its two pivotal studies of aducanumab showed a statistically significant benefit at slowing cognitive and functional decline in patients with early Alzheimer’s. A second trial failed to achieve that goal, but did show a benefit for a subset of patients who were given a high dose for at least 10 months.

In March, it opened a follow-up long-term safety study to 2,400 people who had previously participated in trials of aducanumab, like Flagg.

Many Alzheimer’s researchers say Biogen should conduct a third large study to prove aducanumab works. They worry about its possible side-effects, such as brain-swelling, and the potential cost.

“Aducanumab’s efficacy as a treatment for the cognitive dysfunction in Alzheimer’s disease cannot be proven by clinical trials with divergent outcomes,” said Mayo Clinic neurologist Dr. David Knopman, who was recused from the expert panel because he helped conduct the trials.

Others believe the FDA could approve the drug without another trial.

Previous clinical studies had largely targeted patients in later stages of the disease, while many experts now believe attacking Alzheimer’s as early as possible may be the key to success. But there was a lack of clarity on how to assess a drug’s success when functional deficits are less pronounced.

In 2018, the FDA revised its standard of proof guidance for reviewing Alzheimer’s drugs by essentially combining what had been separate goals for cognition, or memory, and day-to-day function. The new guidance stressed the need for a drug to show “clinically meaningful” benefits, a term it has not clearly defined.

Alzheimer’s advocacy groups are pushing for a broad definition, saying it should include preserving the ability to perform daily activities such as shopping independently or remembering to turn off a stove.

“They have been trying to lower the bar and help any company to get a drug approved,” said Dr. Marwan Sabbagh, from the Cleveland Clinic Lou Ruvo Center for Brain Health in Las Vegas. “How much (improvement) do you need to be clinically meaningful? Naturally this is very subjective.”

The FDA did not immediately respond to a request for comment.

(Reporting by Deena Beasley; Editing by Caroline Humer and Bill Berkrot)

Musk’s Neuralink venture promises to reveal a ‘working’ brain-computer device

By Tina Bellon

(Reuters) – Billionaire entrepreneur Elon Musk’s neuroscience startup Neuralink on Friday is expected to detail its latest innovations for implanting minuscule computer chips in human brains, fueling expectations among scientists who closely watch the company.

Co-founded by Musk in 2016, Neuralink aims to implant wireless brain-computer interfaces that include thousands of electrodes in the most complex human organ to help cure neurological conditions like Alzheimer’s, dementia and spinal cord injuries and ultimately fuse humanity with artificial intelligence.

The company said it will provide an update on its work during a live webcast late on Friday afternoon, with Musk tweeting that the presentation will include a “working Neuralink device.”

Musk, who frequently warns about the risks of artificial intelligence, is no stranger to revolutionizing industries as chief executive of electric vehicle company Tesla Inc and aerospace manufacturer SpaceX.

During a Neuralink presentation in July 2019, Musk said the company was aiming to receive regulatory approval to implant its device in human trials by the end of this year.

“This has a very good purpose, which is to cure important diseases — and ultimately to secure humanity’s future as a civilization relative to AI,” Musk said at the time.

The company promises to implant a sensor roughly eight millimeters in diameter, or smaller than a fingertip, potentially under only local anesthesia. With the help of a sophisticated robot, flexible threads or wires smaller than a human hair are implanted in brain areas responsible for motor and sensory functions.

Neuroscience experts said that while Neuralink’s mission to read and stimulate brain activity in humans is feasible, the company’s timeline appeared overly ambitious.

“Everyone in the field would be very impressed if they actually showed data from a device implanted in a human,” said Graeme Moffat, a neuroscience research fellow at the University of Toronto.

Small devices that electronically stimulate nerves and brain areas to treat hearing loss and Parkinson’s disease have been implanted in humans for decades.

Neuroscientists have also conducted brain implant trials with a small number of people who have lost control of bodily functions due to spiral cord injuries or neurological conditions like strokes. Humans in those trials could control robotic limbs or small objects, like a computer keyboard or mouse cursor, but have yet to complete more sophisticated tasks.

Most of the current cutting-edge research in brain-machine interface is conducted on animals, scientists note, with safety challenges and lengthy regulatory approval procedures preventing larger human trials.

Brain-machine interface science has had a surge in investment and business activity over the past five years, largely thanks to advancements in material, wireless and signaling technology.

But scientists still face a range of issues, including preventing tissue scarring around the implant, the quality of measurements and the development of machine-learning algorithms to interpret brain signals, said Amy Orsborn, an assistant professor at the University of Washington who researches neural interfaces.

“I don’t think we know what the magic bullet is, we only know the problem,” Orsborn told Reuters.

(Reporting by Tina Bellon in New York; Editing by Joe White and Dan Grebler)

U.S. Alzheimer’s deaths jump 54 percent; many increasingly dying at home

A healthy brain compared to a brain affected by a severe case of Alzheimer's Disease. Courtesy of Wikimedia Commons

By Julie Steenhuysen

CHICAGO (Reuters) – U.S. deaths from Alzheimer’s disease rose by more than 50 percent from 1999 to 2014, and rates are expected to continue to rise, reflecting the nation’s aging population and increasing life expectancy, American researchers said on Thursday.

In addition, a larger proportion of people with Alzheimer’s are dying at home rather than a medical facility, according to the report released by the U.S. Centers for Disease Control and Prevention (CDC).

Alzheimer’s is the sixth-leading cause of death in the United States, accounting for 3.6 percent of all deaths in 2014, the report said.

Researchers have long predicted increased cases of Alzheimer’s as more of the nation’s baby boom generation passes the age of 65, putting them at higher risk for the age-related disease. The number of U.S. residents aged 65 and older living with Alzheimer’s is expected to nearly triple to 13.8 million by 2050.

There is no cure for Alzheimer’s, a fatal brain disease that slowly robs its victims of the ability to think and care for themselves.

According to the report by researchers at the CDC and Georgia State University, 93,541 people died from Alzheimer’s in the United States in 2014, a 54.5 percent increase compared with 1999.

During that period, the percentage of people who died from Alzheimer’s in a medical facility fell by more than half to 6.6 percent in 2014, from 14.7 percent in 1999.

Meanwhile, the number of people with Alzheimer’s who died at home increased to 24.9 percent in 2014, from 13.9 percent in 1999, researchers reported in the CDC’s weekly report on death and disease.

The sharp increase in Alzheimer’s deaths coupled with the rising number of people with Alzheimer’s dying at home have likely added to the burden on family members and others struggling to care for their stricken family members, they said.

The report suggests these individuals would benefit from services such as respite care and case management to ease the burden of caring for a person with Alzheimer’s.

Alzheimer’s is the leading cause of dementia and affects 5.5 million adults in the United States. It is expected to affect 13.8 million U.S. adults over 65 by the year 2050.

(Reporting by Julie Steenhuysen)

U.S. Senate joins House to pass sweeping new health bill

A participant prepares to receive an antibody infusion of a drug that is part of a clinical trial for a functional HIV cure at the National Institutes of Health in Bethesda, Maryland, U.S. November 22, 2016 in this still image from video.

By Toni Clarke

(Reuters) – The U.S. Senate voted overwhelmingly on Wednesday to support sweeping legislation that will reshape the way the Food and Drug Administration approves new medicines.

It will also provide funding for cancer and Alzheimer’s research, help fight the opioid epidemic, expand access to mental health treatment and advance research into precision medicine.

Two years in the making, the 21st Century Cures Act was passed last week by the House of Representatives and will now go to President Barack Obama to sign into law. Supporters say it will speed access to new drugs and devices, in part by allowing clinical trials to be designed with fewer patients and cheaper, easier-to-achieve goals.

“For the second consecutive year, the Senate is sending the President another Christmas miracle for his signature,” Senator Lamar Alexander, a Republican from Tennessee said in a statement. “Last year, it was the Every Student Succeeds Act, and this time, it’s the 21st Century Cures Act — a bill that will help virtually every American family.”

Critics of the legislation say it gives massive handouts to the pharmaceutical industry and will lower standards for drug and medical device approvals.

“This gift – which 1,300 lobbyists, mostly from pharmaceutical companies, helped sell – comes at the expense of patient safety by undermining requirements for ensuring safe and effective medications and medical devices,” consumer watchdog Public Citizen said in a statement.

Democratic Senator Elizabeth Warren was among the handful of senators who voted against the bill, as was independent senator and former Democratic presidential candidate Bernie Sanders. Each decried what they described as big handouts to the pharma industry. Even so the bill passed 94-5. The House passed it by a vote of 392-26.

The $6.3 billion act, sponsored by Republican Representative Fred Upton, authorizes $4.8 billion for the National Institutes of Health and $500 million to the Food and Drug Administration.

It also calls for $1 billion over two years to battle the opioid epidemic. On Tuesday the Drug Enforcement Administration issued a report showing that in 2014 about 129 people died every day as a result of drug poisoning. Of those, 61 percent are opioid or heroin related.

“Opioids such as heroin and fentanyl – and diverted prescription pain pills – are killing people in this country at a horrifying rate,” Acting Administrator Chuck Rosenberg said. “We face a public health crisis of historic proportions.”

The bill also calls for $1.8 billion in funding for Vice President Joseph Biden’s Cancer Moonshot initiative designed to bolster cancer research by reducing bureaucracy and promoting research collaboration.

Critics note that the money described in the bill must be appropriated by separate funding bills and that the money may ultimately never materialize. Yet the changes to the clinical trial process, something long sought by the drug industry, will be set in stone regardless of whether money for the research projects is forthcoming.

Among those changes: Greater prominence will be given to “real world” evidence gathered outside the framework of a randomized, controlled clinical trial, the gold standard for determining whether a drug is safe and effective. Such evidence could be much easier for drug companies to collect.

“The passing of 21st Century Cures Act is a show of extraordinary bipartisan unity after a divisive election that should be celebrated,” said Ellen Sigal, chair of the patient advocacy group Friends of Cancer Research.

Under the Act patient input will be formally incorporated into the FDA’s drug review process.

Funding for the Act will be offset by reductions in some Medicaid payments and through the sale of oil from the Strategic Petroleum Reserve. The White House supports the bill but said earlier it was concerned that draining the Petroleum Reserve “continues a bad precedent of selling off longer term energy security assets to satisfy near term budget scoring needs.”

(Reporting by Toni Clarke in Washington; editing by Leslie Adler and Tom Brown)

Scientists Claim Finding Key In Stopping Alzheimer’s

British scientists say they have found the key to stopping Alzheimer’s disease in the early stages.

The study at Cambridge University could lead to a “statin-like” drug that could be prescribed to stop dementia.

The scientists found a naturally occurring molecule that slows down the formation of plaque in the brain.  The plaques are closely connected to memory loss and other symptoms of Alzheimer’s.

“This is the starting point for finding a drug that stops Alzheimer’s disease in its tracks. It might be used when the first symptoms appear. But another potential approach is that people would take it as a preventative drug,” said the study’s lead author, Dr. Samuel Cohen.

The molecules that slow the plaque are Brichos, a family of proteins that naturally exist in human lungs.  Testing in mice showed the molecules stick to fibrils and stop them from forming more plaques.

“There may well be lots of other molecules like this – we just have not been looking until now because it was not clear what to look for,” Dr. Cohen said.

“People could take them in their 60s to stop these proteins grouping together, well before the symptoms appear, which would reduce the risk of developing the devastating effects of this disease.”

New Test Can Predict Alzheimer’s

Scientists in Britain have developed a test that can detect as much as a year in advance if a patient will develop Alzheimer’s disease.

The test comes after a decade of research by Oxford University and King’s College London.  A study showed that the brain develops 10 proteins just before the disease takes hold in the brain.

The doctors hailed the test as groundbreaking because once someone develops Alzheimer’s, there’s no real way to treat it.  With the development of an early warning test, doctors hope to find a way to treat a patient to stop the development of Alzheimer’s.

“Although we are making drugs [to treat Alzheimer’s] they are all failing. But if we could treat people earlier it may be that the drugs are effective,” said Simon Lovestone, professor of translational neuroscience at Oxford. “Alzheimer’s begins to affect the brain many years before patients are diagnosed with the disease. If we could treat the disease in that phase we would in effect have a preventative strategy.”

The test has been proven to have 87 percent accuracy in predicting the onset of Alzheimer’s.

My War on Alzheimer’s

I declared War on Alzheimer’s a few months back just like I did with diabetes years ago.  I just said I’m tired of my friends dying of it.  I’m tired of people that I love leaving you before they die.  It’s just wrong.

The Bible says in 2 Timothy 1:7 that God has given us a sound mind!  “For God hath not given us the spirit of fear; but of power, and of love, and of a sound mind.” Now if God has given us a sound mind, then who do you think takes it away? Only a deceiving enemy bent on death and destruction!

So, I said there’s got to be some answers. And then I found out some countries have almost no Alzheimer’s so it had to be environmental, or something we were doing wrong.  And you would see a husband and wife (no blood relation) and they both would have Alzheimer’s. That made me think maybe it’s environmental, maybe it’s something we’re eating, maybe it’s something we’re doing wrong.  As I began to study, I found that there was a repeated theme of a #1 answer – coconut! Continue reading →

Cholesterol Linked To Alzheimer’s Disease

A new research study has linked “bad” cholesterol to Alzheimer’s disease.

The study showed patients with high levels of “bad” cholesterol in their blood were more likely to have tangles of protein inside their brain cells, a common physical symptom of Alzheimer’s.  The tangles, called beta amyloid plaques, interfere with the function of brain cells.

The exact causes of the build up are not yet understood and will be undergoing further testing.

However, the study showed that “good” cholesterol actually had a preventative effect on the brain and reduced the plaques on the brain.

The doctors noted the cholesterol that can be linked to Alzheimer’s is the same as the kind that increases heart disease and the risk for a heart attack.

Parallel research is showing that the risk of Alzheimer’s or dementia could be reduced by a third if cholesterol is brought under control.  A healthy diet with organic foods and natural sweeteners contributes to increasing good cholesterol.