Xinhua news agency, Beijing, Nov. 2 (reporter Chen Fang, Dong Ruifeng) reporter learned from Shanghai Institute of pharmaceutical research of Chinese Academy of Sciences on Nov. 2 that a new drug for Alzheimers disease developed by China Ocean University, Shanghai Institute of pharmaceutical research of Chinese Academy of Sciences and Shanghai Green Valley Pharmaceutical Co., Ltd. has been approved by the State Drug Administration and can be used for mild to moderate Alzheimers disease and improve patients Cognitive function. The drug is the first time in the world and will provide new treatment options for patients.
Alzheimers disease is commonly known as Alzheimers disease, once the disease, peoples memory, thinking and judgment ability will be like the eraser in the mind slowly wiped away. According to the international Alzheimers Association, there are about 48 million patients in the world, and one new case will be added every three seconds. With the aging of the population, the harm of Alzheimers disease is more and more obvious.
It is understood that 1199 subjects participated in the phase 1, phase 2 and phase 3 clinical trials. Among them, the third phase of clinical practice was organized by the mental health center affiliated to the Medical College of Shanghai Jiaotong University and Beijing Union Medical College, and carried out in 34 third-class first-class hospitals across the country, with 818 subjects medication observation completed. The whole clinical trial is managed by AI kunwei, a global famous outsourcing service organization for new drug research and development.
The results of a 36 week three-phase clinical study showed that nine phases one can significantly improve cognitive impairment in patients with mild and moderate Alzheimers disease. Compared with the placebo group, the cognitive function of the main efficacy indicators improved significantly, and the cognitive function scale score improved by 2.54 points (P < 0.0001). The incidence of adverse events was similar to that of placebo group.
According to Geng Meiyu, the preclinical mechanism of action shows that nine phases one can improve cognitive dysfunction by reshaping the balance of intestinal flora, inhibiting the abnormal increase of specific metabolites of intestinal flora, reducing peripheral and central inflammation, reducing u03b2 - amyloid protein deposition and tau protein hyperphosphorylation. The unique mechanism of targeting brain gut axis provides an important scientific basis for deep understanding of the clinical effect of nine phases one.
Source: editor in charge of Xinhua News Agency: Qiao JunJing, nbj11279