|On Saturday, China’s National Medical Products Administration announced that the drug called Oligomannate for the treatment of Alzheimer's disease has been given the go signal for its release to the market / Photo by: FukaiNashi via Wikimedia Commons|
The Chinese government approved a new drug to treat Alzheimer's disease—the first one that has the potential to reverse the condition.
On Saturday, China’s National Medical Products Administration announced that the drug called Oligomannate for the treatment of "mild to moderate Alzheimer’s disease and improving cognitive function" has been given the go signal for its release to the market. Oligomannate is a seaweed-based drug that was inspired by the low incidence of Alzheimer's among the elderly who consume seaweed on a regular basis.
The drug will go on sale as researchers continue with additional clinical trials, although it will be closely monitored and Oligomannate could be withdrawn if they see any safety issues.
Improving Cognitive Function
Banking on the low occurrence of Alzheimer's in people who regularly consume seaweed, the researchers began looking for possible connections. By 1997, they were able to identify a unique sugar contained in the seaweed they believe is crucial in the phenomenon.
According to CNN, the sugar content in the seaweed suppresses certain bacteria in the gut that can cause neural degeneration and inflammation of the brain, which could lead to Alzheimer's. Green Valley, a pharmaceutical company in Shanghai that will distribute Oligomannate, conducted a clinical trial that involved 818 patients to confirm the mechanism.
The new drug was found to statistically improve the patients' cognitive performance by an average of 2.54 points in standard test scores from 0 to 70, in which patients who scored 16 points or more are likely to have Alzheimer's.
Philip Scheltens, who advises Green Valley and heads the Alzheimer Center Amsterdam, said the results deepened the understanding of the factors at play in Alzheimer's and suggested that the gut microbiome "is a valid target for the development of therapies."
Oligomannate demonstrates "encouraging results" when it is compared to the existing treatment—acetylcholinesterase inhibitors—for mild to severe Alzheimer's, according to Vincent Mok, head of the neurology division at the Chinese University of Hong Kong.
"It is just as effective but it has fewer side effects," Mok told CNN. "It will also open up new avenues for Alzheimer's research, focusing on the gut microbiome."
|Banking on the low occurrence of Alzheimer's in people who regularly consume seaweed, the researchers began looking for possible connections / Photo by: wrangel via 123RF|
A Long Journey
As of today, there is no cure for Alzheimer's. But the results of the clinical trial showed that treatment, which could reverse the condition, is still possible. "Long in the dark, the Alzheimer’s disease has finally seen a break of dawn from the East," said Beijing neurologist Song Juexian.
The researchers did not expect that developing the idea to make an effective drug would take them this long. Geng Meiyu, the lead researcher from the Chinese Academy of Sciences' Shanghai Institute of Materia Medica, said the use of sugar with large molecular structure was "unprecedented" as others were all developing small molecule medicine.
Pharmaceutical companies have spent hundreds of billions of dollars on numerous clinical drug trials over the past two decades. During those times, more than 320 candidate drugs were subjected to these studies and only five were approved for clinical use in relieving symptoms—and none could stop the brain cells from disintegrating.
Repeated costly failures led to the termination of many Alzheimer’s-related programs. The research team faced major challenges such as explaining to reluctant authorities how the drug worked and why it should be approved.
A lot of theories emerged about the causes of Alzheimer's but none of them seemed to apply to Oligomannate, reported the South China Morning Post, a Hong Kong English-language newspaper providing news and authoritative insights from Hong Kong, China, and the world.
It added that the discovery Geng and his team made in September provided evidence for the efficacy of the drug: Oligomannate was a multitasking agent. Not only does it reduce the formation of a protein harmful to neurons, but it also regulates the bacterium colonies in the gut and reduces the risk of brain inflammation.
Far From the End
The drug shows a promising future for treating Alzheimer's, but Song cautioned that it was "far from the end of the battle" as more trials are needed to see if the mechanisms of Oligomannate provide protection and slow down the development of the disease in patients.
Still, the drug has already been proven for its efficacy in treating the decline in brain function due to the disease. This decline is divided into seven stages, and SCMP reported that the new drug was found to be effective on conditions up to stage 4 (which includes difficulty to add simple numbers, the recollection of recent memory, paying bills, and remembering details about life histories).
Oligomannate might just be the treatment needed to reverse the effects of the progressive disorder believed to cause up to 70 percent of the reported cases of dementia worldwide. Dementia affects about 50 million people around the world with 9.5 million being in mainland China, Hong Kong, and Taiwan.
The WHO predicted that by 2050, Alzheimer's will affect 150 million people worldwide with over a quarter of whom being in China.
|The WHO predicted that by 2050, Alzheimer's will affect 150 million people worldwide with over a quarter of whom being in China / Photo by: Cathy Yeulet via 123RF|