Alzheimer’s Disease approved in China

UNITED STATES, WASHINGTON (OBSERVATORY SCIENCE) — Alzheimer’s disease remains a very urgent problem, especially given the growing problem of aging society . Experts are not leaving attempts to find out the causes of this ailment, and are also looking for new ways to diagnose and treat this so-called memory oncology.

It is worth noting that so far the target of most of the developed drugs for Alzheimer’s disease has been beta-amyloid proteins. They form plaques in the brain of the diseased and are believed to interfere with the normal transmission of signals in the central nervous system.

But, given the many failed clinical trials of anti-amyloid drugs, scientists are forced to look for other treatment strategies.

Chinese experts have proposed using a new agent derived from brown algae for these purposes .

The drug has been created thanks to many years of research by Professor Geng Meyyuy ( Geng Meiyu ) from the Shanghai Research Institute of Chinese Academy of Sciences. In September, Geng and her colleagues published their laboratory animal test results in the prestigious Cell Research.

The study demonstrated the likely pathway for the development of the disease, as well as a possible effective way to treat it.

It turned out that with the progression of the disorder in the experimental mice, the intestinal microbiota changed. This led to the activation and excessive reproduction of immune cells that penetrated the brain and exacerbated the inflammation characteristic of Alzheimer’s disease.

Treatment of mice with GV-971 with the unpronounceable name of the active substance sodium oligomannurarate restored the intestinal microbiome of rodents and reduced inflammation in the brain, alleviating the symptoms of the disease.

The logical next step was to test the drug based on brown algae in humans.

The studies (more than 800 volunteers took part) were conducted by two Chinese universities with the participation of a pharmaceutical company and lasted 36 weeks. The results showed that the substance proposed by Gen changed the composition of the intestinal microbiome in humans.

Against the background of this transformation, a qualitative and persistent improvement in cognitive functions was observed in treated people compared with the control group. Moreover, persistent positive results have appeared since the fourth week of treatment, according to the creators of the drug.

It was possible to find out thanks to a regular assessment of the cognitive abilities of participants using a special scale for assessing Alzheimer’s disease.

It allows you to analyze short-term and long-term memory, understanding of commands and other brain functions. The researchers found that the average difference between the treated and placebo groups was 2.54 points.

Experts explain that such a difference is considered statistically significant. The figures obtained, however, did not convince everyone. According to some neuroscientists, this difference is not clinically important. Others, on the contrary, note that it indicates a significant improvement in the cognitive abilities of volunteers.

According to Professor Jeffrey Cummings, consult the drug developers in Shanghai, there has been progress exceeds the effect of the existing drugs already approved.

Despite controversy among neuroscientists, it became known that last week the Chinese regulatory authority approved the use and sale of GV-971.

True, researchers will need to provide some additional data demonstrating the safety and effectiveness of the medication they developed.

“This is a very exciting and important event. GV-971 is the first drug in the world approved for the treatment of Alzheimer’s since 2003,” Cummings adds to Science.

However, like the competent services of China, he believes that more evidence is needed today to gather the effectiveness of sodium oligomannurate in treating brain-destroying disease.

By the way, Professor Geng herself in her scientific article notes the need for further research. They will help to better understand the relationship of intestinal microbiome with brain inflammation in Alzheimer’s disease. In addition, scientists should study the healing potential of GV-971 in more detail, she said.

In the meantime, Green Valley, a pharmaceutical company involved in clinical trials, has already presented trials of the new promising compound at several conferences. In addition, they can be found on the website of the company itself and in the press releases of the Shanghai Materia Medica Research Institute.

Soon the concern intends to obtain approval for the use of its drug in other countries. To do this, the company will begin global clinical trials in early 2020. It is planned that the United States, countries of Europe and Asia will take part in them.

It is important to note that the drug developed by Chinese scientists also did not show significant side effects during clinical trials. This fact is likely to be taken into account by regulatory organizations when deciding whether to approve the use of a drug around the world.

For detailed research data, visit the National Library of Medicine website.

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