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China approves new drug to treat Alzheimer's; clinical trials planned for 2020 in the United States



The authorities in China have approved a drug for the treatment of Alzheimer's disease, the first new drug that has the potential to treat the cognitive disorder in 17 years.

The seaweed-based drug, called Oligomannate, can be used to treat mild to moderate Alzheimer's, according to a statement from China's drug office. However, the approval is conditional, and means that, although it can be sold during further clinical trials, it will be strictly monitored and could be withdrawn should security issues arise.

In September, the team behind the new drug, led by Geng Meiyu at the Shanghai Institute of Materia Medica of the Chinese Academy of Sciences, said they were inspired to see seaweed because of the relatively low prevalence of Alzheimer's among people who consume it regularly.

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In an article in the journal Cell Research, Geng's team described how a sugar contained in seaweed suppresses certain bacteria contained in the gut that can cause neural degeneration and inflammation of the brain, which leading to Alzheimer's.

This mechanism was confirmed during a clinical study conducted by Green Valley, a Shanghai-based pharmaceutical company to market the new drug.

Performed on 818 patients, the study found that Oligomannate – derived from brown algae – can statistically improve cognitive function among people with Alzheimer's in as little as four weeks, according to a Green Valley statement.

"These results advance our understanding of the mechanisms that play a role in Alzheimer's disease and suggest that the gut microbiome is a valid target for the development of therapies," neurologist Philip Scheltens, who advises Green Valley and heads Alzheimer's Center Amsterdam, said that in the statement.

The company said Oligomannate will be available in China "very soon," and it is currently seeking approval to market it overseas, with plans to launch third-phase clinical trials in the United States and Europe in early 2020.

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Alzheimer's disease, which starts with memory loss and escalates to severe brain damage, is believed to cause 60% to 70% of cases of dementia reported worldwide, according to the World Health Organization. Dementia affects an estimated 50 million people worldwide, including 9.5 million people in mainland China, Hong Kong and Taiwan.

Named after Alois Alzheimer, the neuropathologist who discovered the disease in 1906, and has so far confused scientists and pharmaceutical companies. [19659002] In October, US pharmaceutical giant Biogen said it would pursue Food and Drug Administration (FDA) approval for an experimental treatment called aducanumab, after announcing in March that it was canceling a major clinical trial on the drug.

Johnson & Johnson, Merck, Pfizer, and Eli Lilly have previously abandoned projects to develop a drug for Alzheimer's after unsatisfactory clinical data.


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