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Microbiome-altering Alzheimer’s drug unexpectedly approved in China

sodium oligomannate alzheimers

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#1 Engadin

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Posted 06 November 2019 - 10:17 AM


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S O U R C E :   NewAtlas

 

F U L L   T E X T   P R I M A L   S O U R C E :   Cell Research > Sodium oligomannate therapeutically remodels gut microbiota and suppresses gut bacterial amino acids-shaped neuroinflammation to inhibit Alzheimer’s disease progression

 

 a surprise to many researchers around the world, Chinese authorities recently approved a novel drug claimed to improve cognitive function in patients with Alzheimer’s disease. The drug, derived from a marine algae, is the first new Alzheimer’s drug to reach the market anywhere in the world in almost 20 years, and is suggested to reduce neuroinflammation by modulating a person’s gut microbiome.

 

In a surprise to many researchers around the world, Chinese authorities recently approved a novel drug claimed to improve cognitive function in patients with Alzheimer’s disease. The drug, derived from a marine algae, is the first new Alzheimer’s drug to reach the market anywhere in the world in almost 20 years, and is suggested to reduce neuroinflammation by modulating a person’s gut microbiome.

 

GV-971, or sodium oligomannate, is derived from a common form of seaweed called brown algae. For several years the compound has been under investigation in China as a treatment to slow, or even reverse, cognitive decline associated with mild to moderate cases of Alzheimer’s disease.

 

The latest announcement from China’s National Medical Products Administration (NMPA) has granted the drug “conditional approval”, meaning it is to be fast-tracked to market based on positive early Phase 3 trial results. The “conditional approval” requires ongoing studies to verify efficacy and safety, however, it can now move to open market sales in China within the next month or two.

 

"I have been doing research on Alzheimer's disease for 50 years, participated in multiple global multi-center studies of multiple drugs, and have never found a satisfactory treatment for Alzheimer's disease," says Zhang Zhenxin, MD, a principal investigator on the latest trial. "The result of the 9-month trial of Oligomannate is exciting. We finally see hope and dawn. I am sincerely happy for the patients and their families."

 

The particular Phase 3 clinical trial covered 818 patients across 34 hospitals in China. The trial was double-blind and placebo-controlled, running for 36 weeks. The results are yet to be published in a scientific journal but it is claimed cognitive improvements were seen in patients as soon as four weeks after treatment commenced.

 

“The mean difference between Oligomannate and placebo groups in ADAS-Cog12 Score (a standard cognitive measure commonly used in AD studies) was 2.54 (p< 0.0001), with sustained efficacy from first month of treatment to the end of 9 months of treatment,” says Shanghai Green Valley Pharmaceuticals, the company developing the drug. “Oligomannate was safe and well tolerated with side effects comparable to the placebo arm.”

 

It is unclear exactly how clinically meaningful those improvements actually are. While they are undeniably statistically significant, experts such as Mark Oremus from the University of Waterloo in Canada, are skeptical.

 

“I would say that a 2.54 improvement on the ADAS-Cog is not clinically important, and I would also point out that a 36-week study is far too short to evaluate the medium- to long-term effects of any Alzheimer’s disease medication,” Oremus recently said to Science magazine.

 

Perhaps the most compelling mystery surrounding the new drug is its mechanism of action. An article published in September in the highly credible journal Cell Research presented the first clear hypothesis explaining how it may be working, suggesting the drug reduces neuroinflammation by remodeling the gut microbiome. Unlike the majority of recent Alzheimer’s research, which focuses directly on clearing out the toxic protein accumulations thought to be the primary cause of neurodegeneration in Alzheimer’s, the new drug seems to modulate bacteria activity in the gut.

 

commentary on the research published in September suggests the description of Oligomannate’s mode of action elegantly demonstrates how, “a gut microbiota imbalance facilitates peripheral immune cells to infiltrate the brain, resulting in enhanced microglial activation that contributes to cognitive impairment and Aβ burden in mouse models of Aβ amyloidosis.”

 

The research is certainly an intriguing insight into the gut-brain connection, with profound implications for future Alzheimer’s research, suggesting microbiome modulation may be a highly effective way to counter the neurodegeneration associated with the disease.

 

 

 

 

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#2 Daniel Cooper

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Posted 06 November 2019 - 08:57 PM

Since this stuff is derived from seaweed, and the research was started because it was noticed that Asian populations that ate lots of seaweed had a lower incidence of Alzheimer's, is there a seaweed extract/supplement that will give us some of these benefits?

 

 

 

 

 

 



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#3 nickthird

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Posted 07 November 2019 - 10:18 PM

You can buy the brown seaweed supplement on Amazon. I got this recently for purported hunger / cravings reduction.



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#4 Engadin

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Posted 08 November 2019 - 04:26 PM

You can buy the brown seaweed supplement on Amazon. I got this recently for purported hunger / cravings reduction.

 

 

Nickthird, I am afraid it won't be as easy as that given there are many different species of brown seaweed in the market, and AFAIK chinese researchers haven't publicly pointed out which of them is the oligomannate's source. Its scientific name would clear out all doubts.


Edited by Engadin, 08 November 2019 - 04:29 PM.

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#5 xEva

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Posted 09 November 2019 - 09:19 AM

actually, the only brown seaweed in human consumption is kelp. Japanese call it kombu: Characteristics of Different Kombu Seaweed and Its History

 

PS

oops it turns out that my favorite, wakame, is also a brown alga (Undaria pinnatifida -- but it looks so green to me! nori is red)

 


Edited by xEva, 09 November 2019 - 09:38 AM.

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#6 Engadin

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Posted 09 November 2019 - 11:32 AM

actually, the only brown seaweed in human consumption is kelp. Japanese call it kombu: Characteristics of Different Kombu Seaweed and Its History

 

PS

oops it turns out that my favorite, wakame, is also a brown alga (Undaria pinnatifida -- but it looks so green to me! nori is red)

 

Hi xEVA, kelp was also my first choice, but my wife has been to Shanghai recently and has found hundreds of sorts of ingredients in the food market that are unavailable in Occident, among them many seaweed. That panorama soon changed my mind about there being just one option as oligomannate source . Also in France you'll find several brown/dun seaweed as garnish in the Bourdeaux area at least.


Edited by Engadin, 09 November 2019 - 11:33 AM.

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#7 xEva

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Posted 11 November 2019 - 04:32 AM

well, I doubt it would be something rare. I'd imagine, to the contrary, the source would be a staple, like kombu and wakame, so that the effect would be noted, before someone would think of making it into a drug.
 
Also, if we look at the name 'oligo' means few, and 'mannate' is from mannose, of course. Look what google gave me on mannose:
 

It can be found in cell walls of brown algae (kelp), where it is a component of a long chained polysaccharide named mannan. As an ingredient of foods, free mannose can be found whenever the food was thickened with mannanes. Mannose is produced by hydrolysis of mannanes which are often derived from guar beans (cluster beans), locust beans (carobs), or brown algae.

https://www3.hhu.de/...ar/mannose.html

 

 

So I'm guessing oligomannate is based on a shortish version of mannan, And I doubt it matters from which brown algae they make it. Maybe they could make it from beans but seaweed is cheaper -?

 

 

 

By chance I came across this page on wakame extract. It claims an impressive list of benefits (who could have known -- suddenly I like wakame even better!)
 

Immune function
    Increased mobilisation of CD34+ stem cells and CXCR4 expression
    Increased IgG levels by 397%
    Activation of Toll-like receptors 2 and 3 by up to 387%
    Increased wound healing gene expression

Anti-viral activity
    Inhibition of the binding and entry of a range of viruses to host cells
    Significant reduction in the clinical signs of influenza and lung damage

Gut health
    Inhibition of H. pylori adhesion to human stomach cells
    Inhibition of E. coli adhesion to human epithelial cells

Anti-cancer
    Safe to administer in oncology. No adverse interactions with a range of chemotherapy drugs
    Decreased tumour growth
    Induced cell cycle arrest or apoptosis in a range of cancer cells

Anti-inflammatory
    Reduction and downregulation of inflammatory marker Interleukin-6
    Inhibition of the activity of inflammatory enzyme LOX-15
    Inhibition of the inflammatory enzyme hyaluronidase

Anti-ageing
    Significantly increased the production of Sirtuin 1 (SIRT1) protein by 28%


Edited by xEva, 11 November 2019 - 04:49 AM.

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