Although this study is about Alzheimer's Disease (AD), it is very interesting in showing how the gut microbiota can be manipulated to very good effect and that fact is very important for many diseases including PD. It is also worth noting that some of the methods of action that have so far been discovered in studying GV-971 are likely to be relevant in PD also. GV-971 has been found to modulate the gut microbiome and reduce neuroinflammation through the gut brain axis while improving cognitive function in people with AD. Cognitive function impairment is a PD issue too.
Sodium Oligomannate (GV-971) is derived from seaweed and it has a safety profile that is very similar to placebo. It has been tested at 600 mg/day and 900 mg/day and the 900 mg/day results were superior to the 600 mg/day results. Future studies are going to consider higher dosing.
Very importantly about GV-971 is that it is already in testing and that testing is being done in humans and is already at advanced testing stages around the world, meaning that we are only looking at a relatively very short period of time to potential availability in other areas of the world besides China where it was discovered for use in AD and has just been included in their “National Reimbursement Drug List”. So GV-971 is already available in China, but studies in the US and Canada are ongoing.
GV-971 was co-discovered and co-developed by Ocean University of China (OUC), Shanghai Institute of Materia Medica (SIMM) of Chinese Academy of Sciences and Green Valley. After over 21 year comprehensive investigation, GV-971 is the first multi-targeting and carbohydrate-based drug for the treatment of AD in the world.
How effective is GV-971? This link discusses study results and findings :
Just for the sake of comparison it is worth noting that it has previously been shown that manipulation of the gut microbiome can have a positive impact on AD as shown in this 2016 study :
In this Iranian study above, although they achieved positive results using high dose probiotic supplementation, no specific follow up study has been done to add confirmation to the results even though AD is the most common neurodegenerative disease in the world.
It is nice once in awhile to find a drug that doesn't have a 10 year waiting period before it could potentially come available to the public. This drug in particular also adds further confirmation to the whole idea that modulating the gut microbiome is a legitimate treatment for modifying disease activity and unlike the FMT studies that also came out of Asia, this is already available in China and likely around the world in relatively short order as drugs go.
Although this is good news, it would be nice to see productive microbiome manipulation studies like these done in the US to add confirmation to these other studies and or actually bring a product to market.
Art
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Sodium oligomannate (development code GV-971) is a mixture of oligosaccharides isolated from the marine algae Ecklonia kurome that is used in China as a treatment for Alzheimer's disease en.wikipedia.org/wiki/Sodiu... kurome (Japanese: 黑布 (kurome), Chinese: 鹅掌菜) is a brown alga species in the genus Ecklonia found in the Sea of Japan.
It will be interesting to learn if it has a similar effect in PD dementia now that China is already using it. I didn't see that they gave a timeline for when it will be available in the US or Canada though they did mention that they are already testing it here.
Seaweed is noted for its DHA, iodine and magnesium content which should all be good for the brain, but I suspect that GV-971 is a bit more potent in improving memory. I noticed in one part of their study they mentioned that the best benefit was among the lower scorers in testing. Lower score equals less cognitive dysfunction.
Kelp is known for many potential healthful effects, but the studies for Ecklonia Kurome are limited. In general these derivatives increase SCFAs including butyrate. This abstract highlights this :
It seems like many of these things like Ecklonia that are mentioned on this forum as being potentially useful in PD and other health conditions often times manipulate the gut microbiome via increased production of SCFAs. I consider these to be worthy clues for increased meaningful research into the manipulation of the gut microbiome to improve health. It seems that some of the most progressive research in this area is coming out of Asia.
It is a little different in that it appears that the three entities worked together to bring it to market, but yes, one of them is a pharmaceutical company. That seems fairly out of the ordinary to me, but in the end it had to take a lot of time and money to bring it to market and a pharmaceutical would have probably been needed in order to bring the needed funding into play. Those were good sized trials and they don't come cheap.
Now that they have proven it works for AD and have gotten FDA approval to go ahead with Parkinson's Disease trials in North America, I can hardly wait to see their results in PwP!
Apparently GV-971 is in testing for Parkinson's Disease also!!! I guess I was right on that count, but I was not aware that they are going to be trialing it soon for PD according to this report :
>>> ' Based on such findings, the research team at Green Valley Research Institute carried out preclinical research on GV-971's effect on PD based on the common pathological mechanism of neurodegenerative diseases, and found that the drug is able to regulate gut microbiota dysbiosis, suppress α-synuclein aggregation in both the gut and the brain, reduce neuroinflammation, protect dopaminergic neurons, and improve motor and non-motor symptoms. ' <<<
Aiming at the gut microbiome in PD is in line with a lot of newer research.
Art
B Subtilis as PD therapy
& more evidence of alpha synuclein aggregation being an immune response
“The probiotic suppressed accumulation of α-synuclein into Lewy bodies by 75 percent, and prevented the degeneration of dopaminergic neurons “B Subtilis animal study
"In an article published Monday by the scientific journal Cell Research, Rao Yi, a renowned neurobiologist and the president of Capital Medical University in Beijing, questioned a research paper published in the same journal last September explaining the sodium oligomannate product GV-971, the breakthrough Alzheimer’s drug."
"“I have never come across a single drug with so many targets for curing or alleviating one disease,” Rao wrote."
"Seven months ago, Rao reportedly wrote a letter to the National Natural Science Foundation of China, an official body affiliated with the country’s cabinet, to demand an investigation into the September paper published by Geng and her colleagues, as well as the past projects of two other scientists."
"China’s drug regulator greenlighted the distribution of GV-971 last November, on the condition that additional data be gathered to demonstrate its safety and efficacy. The surprisingly seamless approval — the first for any Alzheimer’s drug globally in 17 years — elicited hope as well as skeptics among scientists who thought the drug’s fast-tracked human trials were insufficient."
"GV-971, which claims to treat mild to moderate Alzheimer’s while improving cognition, has been on the market in China since December: A prescription of 42 capsules costs 895 yuan ($128)."
That article was written in July 2020 and this study consisting of 818 participants came out in March 2021 and tends to confirm that Rao Yi might be wrong :
The study tends to confirm the efficacy of GV-971. Here is a quote from the study :
' A total of 818 participants were randomized: 408 to GV-971 and 410 to placebo. A significant drug-placebo difference on the ADAS-Cog12 favoring GV-971 was present at each measurement time point, measurable at the week 4 visit and continuing throughout the trial. The difference between the groups in change from baseline was − 2.15 points (95% confidence interval, − 3.07 to − 1.23; p < 0.0001; effect size 0.531) after 36 weeks of treatment. Treatment-emergent adverse event incidence was comparable between active treatment and placebo (73.9%, 75.4%). Two deaths determined to be unrelated to drug effects occurred in the GV-971 group. '
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