China Gives Conditional OK to Its First Self-developed Alzheimer’s Drug

China has granted conditional approval to its first self-developed treatment for Alzheimer’s disease, a move that may point to revived opportunities in a therapeutic area where drugmakers have burned billions of dollars without yielding a validated new drug.

Oligomannate, which uses extract from marine brown algae as raw material, received a conditional green light to treat mild-to-moderate level AD, the National Medical Products Administration (NMPA) said in a statement on its website late on Saturday.

An effective treatment for Alzheimer’s, which is estimated in 60%-70% of around 50 million dementia cases worldwide, could become one of the best-selling drugs globally.

“Trial results demonstrated that Oligomannate statistically improved cognitive function in mild-to-moderate AD patients as early as week 4 and the benefit was sustained at each follow-up assessment visit,” Shanghai Green Valley Pharmaceuticals, which developed the drug along with two academic institutions in China, said in a statement.

The outlook for a cure is clouded with theoretical uncertainties and high-profile failures. Pharmaceutical giants including Johnson & Johnson, Merck and Pfizer have ditched their projects on unsatisfactory data.

Biogen last month revived its plans to seek U.S. approval for its aducanumab treatment after announcing in March that it would terminate two large clinical trials for the drug. But some analysts believed FDA approval is highly unlikely.

China is fast-tracking approval for innovative drugs at home in a bid to offer more and cheaper options to patients, as many in the rapidly aging country struggle to find alternatives to costly treatments sold by multinational pharmaceutical firms for chronic diseases.

In an August overhaul to its drug administration law, Beijing said conditional approval could be granted to some still-under-research medicines of “predictable” clinical value for life-threatening diseases for which effective treatment is not immediately available.

Further research on Oligomannate’s pharmacological mechanism and long-term safety and effectiveness is required, according to the NMPA statement.

Green Valley said it would launch the drug “very soon” in China. The company also aims to roll out a phase-3 clinical trial with sites in the United States, Europe and Asia in early 2020 to facilitate global regulatory approval of the drug.

Source : Reuters


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First drug that can slow Alzheimer’s dementia . . . . .

Test Given at 8 May Predict Your Brain Health in Old Age

Amy Norton wrote . . . . . . . . .

If you were good with words and puzzles at age 8, you’re likely to fare well on tests of mental acuity at age 70, too.

That’s among the findings of a new study that followed the thinking abilities of a group of Britons born in the 1940s. Researchers found that their performance on standard cognitive tests at age 8 predicted their performance around age 70. People who scored in the top quarter as kids were likely to remain in that bracket later in life.

“Cognition” refers to our ability to pay attention, process information, commit things to memory, to reason and to solve problems.

And it’s no surprise, experts said, that there is a correlation between childhood and adulthood skills.

However, no one is saying that your brain-health destiny is set in childhood, according to senior researcher Dr. Jonathan Schott, a professor of neurology at University College London.

In this study, for example, education also mattered. Older adults who’d gone further in their formal education tended to score higher, regardless of their test performance as children.

A number of past studies have linked higher education levels to a lower risk of dementia. And the new findings bolster that evidence, said Rebecca Edelmayer, director of scientific engagement at the Alzheimer’s Association.

“It’s really unique to have data like this, from a cohort that was followed for 60 years,” said Edelmayer, who was not involved in the study.

Why would education matter in dementia risk? It’s not certain, but Dr. Glen Finney, a fellow of the American Academy of Neurology, explained the “cognitive reserve” theory: Dementia is marked by the buildup of abnormal proteins known as “plaques” and “tangles.” In people with more education, the brain might be better equipped to compensate for such damage, allowing it to function normally for a longer period.

It’s also thought that mental engagement later in life might hold similar benefits. That could mean “challenging yourself to learn something completely new” — like studying an instrument or a foreign language, said Finney, who directs the Geisinger Health System’s Memory and Cognition Program in Wilkes-Barre, Pa. He was also not part of the study.

Beyond education, Finney noted, there is a body of evidence that other lifestyle factors are important in healthy brain aging. Blood pressure control is one, he said.

Finney pointed to a recent clinical trial finding that intensive treatment of high blood pressure lowered older adults’ risk of developing mild cognitive impairment.

That refers to subtler problems with memory and thinking that may precede dementia.

In general, the same things that protect the heart — exercise, controlling cholesterol and blood sugar, and a healthy diet — are also believed to be good for the brain, Edelmayer said.

“We just don’t know yet what the best recipe is for [dementia] risk reduction,” she said.

The current findings were published in Neurology. They’re based on more than 500 U.K. adults born in 1946. When they were 8 years old, they took tests of reading comprehension and other skills. When they were around age 70, they were tested for skills like memory and information processing.

They also underwent PET scans to detect any buildup of plaques in the brain.

It turned out that among participants who tested “cognitively normal,” about 18% did have signs of plaques in their brains. And on average, their test scores were lower, versus participants with no evidence of plaques.

That does not mean those people are destined to develop dementia, Edelmayer pointed out.

However, the findings do support a growing belief among researchers, according to Schott.

The fact that plaques exert subtle influences on mental performance even in people without symptoms is noteworthy. This “provides more evidence for the growing view that when disease-modifying therapies become available, they may have maximum benefits when given very early — and ideally prior to symptom onset,” Schott said.

How would that be done? In the future, Edelmayer said, it might be possible to use certain biological “markers” — such as plaques seen in brain scans — to identify people who are on a trajectory toward dementia.

“But we’re not there yet,” she stressed. “There’s a lot of work to be done.”

According to the Alzheimer’s Association, 5.8 million Americans are living with Alzheimer’s disease — a number that is expected to balloon to nearly 14 million by 2050.

Source: HealthDay

Healthy Eating Habits May Keep Alzheimer’s at Bay

Len Canter wrote . . . . . . . . .

When you hear the word diet, you might think only of weight loss. But a lifestyle diet can bring even greater benefits.

One option that belongs on your radar is the MIND diet created by researchers at Rush University in Chicago.

MIND stands for Mediterranean-DASH Intervention for Neurodegenerative Delay. It’s a hybrid of those two heart-healthy diets, both of which reduce the risk of high blood pressure, diabetes, heart attack and stroke.

In initial studies, the MIND diet offered a huge additional benefit — lowering the risk of Alzheimer’s disease by up to 53% in participants who stuck to it rigorously and by about 35% in those who only did so moderately well. But the key is to start now, no matter your age, because it seems like the longer you follow it, the lower your risk of developing Alzheimer’s.

Do Eat:

  • Green leafy vegetables and other vegetables
  • Nuts
  • Blueberries or strawberries
  • Beans
  • Whole grains
  • Fish
  • Poultry
  • Olive oil
  • Wine

Do Limit:

  • Red meat
  • Butter and stick margarine to less than a tablespoon a day
  • Cheese, pastries, sweets, fried or fast food to one serving in total per week

The MIND diet isn’t complicated. Each day have at least three servings of whole grains, a salad and one other vegetable along with a glass of wine. On most days, make nuts your snack. Have beans every other day, poultry and berries at least twice a week, and fish at least once a week. Equally important is what not to eat. Keep solid fat under one tablespoon a day. Once a week it’s OK to choose one indulgence — cheese or a pastry or a fried or fast food.

Source: HealthDay

Study: Fluctuating Blood Pressure Could Be Bad for Those With Alzheimer’s

The study published in the American Heart Association journal Hypertension sought to add a new understanding about the links between Alzheimer’s, the heart and blood vessels. Past research shows blood pressure variability could be connected to stroke, and researchers of the new study wanted to see if there was a similar link between yo-yoing blood pressure and Alzheimer’s.

Researchers looked at data from a randomized trial of 460 people who were 72 on average and had “mild-to-moderate” Alzheimer’s. After 1 1/2 years, people who scored the highest in blood pressure variability had deteriorated more on a cognitive scale than those with the least amount of variability.

Data on day-to-day blood pressure fluctuations was only available for 46 patients, and in that smaller group, researchers also found “significant associations” between variable blood pressure and dementia after one year, but not after 1 1/2 years.

“Everybody already knows that it’s important to control blood pressure in midlife to reduce your risk of Alzheimer’s later, but this tells us it’s still important to regulate blood pressure when you already have dementia,” said the study’s senior author, Dr. Jurgen Claassen. “More fluctuations might affect whether cognitive function declines more slowly or rapidly.”

Future research is needed to find out if blood pressure variability is truly causing the dementia to worsen, said Claassen, associate professor at Radboud University Medical Center in Nijmegen, Netherlands.

“If that’s true, medication or lifestyle (changes) might help slow down disease progression,” he said. “But it could also be the other way around … that the dementia itself might lead to blood pressure variability, which could be a signal that helps you identify people with Alzheimer’s.”

He also called for studies on how sleep, diet and exercise might help stabilize blood pressure.

“Alzheimer’s treatments are limited at this point, and even a small difference in slowing down the disease’s progression can mean a lot,” Claassen said. “It could be the difference between whether or not a patient is still able to drive a car and live independently.”

Nearly 6 million Americans have been diagnosed with Alzheimer’s disease, including 200,000 people under the age of 65. It’s the most common cause of dementia and is the sixth-leading cause of death in the United States.

Research on the link between blood pressure and Alzheimer’s is relatively new, but a 2018 study in the journal Neurology found the brains of older people with higher blood pressure were more likely to have “tangles,” or twisted strands of protein that are common markers of Alzheimer’s.

Jeffrey Keller, director of the Institute for Dementia Research and Prevention at Louisiana State University in Baton Rouge, called the new research “an important study that continues to fine-tune our understanding of Alzheimer’s and dementia.”

“There is a lot of evidence that fluctuations in blood pressure of people who do not have hypertension are related to adverse cardiac events, so it is not surprising that variability in blood pressure is also linked to negative cognitive function,” said Keller, who was not involved in the new study.

He said the research was limited by its small sample size and by being observational. But he noted the study paves the way for future research, including large studies that use wearable devices to track people’s day-to-day blood pressure variability.

“We’re finding more and more that there is a direct link between blood pressure in the periphery of an individual and the ability of their brain to stay healthy. It’s important for people to stay on top of their blood pressure – not just for their general health, but specifically for their brain.”

Source: HealthDay

How the Eyes Might Be Windows to the Risk of Alzheimer’s Disease

Scott LaFee wrote . . . . . . . . .

Alzheimer’s disease (AD) begins to alter and damage the brain years — even decades — before symptoms appear, making early identification of AD risk paramount to slowing its progression.

In a new study published online in the September 9, 2019 issue of the Neurobiology of Aging, scientists at University of California San Diego School of Medicine say that, with further developments, measuring how quickly a person’s pupil dilates while they are taking cognitive tests may be a low-cost, low-invasive method to aid in screening individuals at increased genetic risk for AD before cognitive decline begins.

In recent years, researchers investigating the pathology of AD have primarily directed their attention at two causative or contributory factors: the accumulation of protein plaques in the brain called amyloid-beta and tangles of a protein called tau. Both have been linked to damaging and killing neurons, resulting in progressive cognitive dysfunction.

The new study focuses on pupillary responses which are driven by the locus coeruleus (LC), a cluster of neurons in the brainstem involved in regulating arousal and also modulating cognitive function. Tau is the earliest occurring known biomarker for AD; it first appears in the LC; and it is more strongly associated with cognition than amyloid-beta. The study was led by first author William S. Kremen, PhD, and senior author Carol E. Franz, PhD, both professors of psychiatry and co-directors of the Center for Behavior Genetics of Aging at UC San Diego School of Medicine.

The LC drives pupillary response — the changing diameter of the eyes’ pupils — during cognitive tasks. (Pupils get bigger the more difficult the brain task.) In previously published work, the researchers had reported that adults with mild cognitive impairment, often a precursor to AD, displayed greater pupil dilation and cognitive effort than cognitively normal individuals, even if both groups produced equivalent results. Critically, in the latest paper, the scientists link pupillary dilation responses with identified AD risk genes.

“Given the evidence linking pupillary responses, LC and tau and the association between pupillary response and AD polygenic risk scores (an aggregate accounting of factors to determine an individual’s inherited AD risk), these results are proof-of-concept that measuring pupillary response during cognitive tasks could be another screening tool to detect Alzheimer’s before symptom appear,” said Kremen.

Source: University of California San Diego


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