A new Chinese drug for Alzheimer’s disease begins the third phase of international clinical trials in the United States
American experts recently stated that the new Alzheimer’s disease drug Mannite Sodium Capsules (trade name “Phase Nine One”) developed by a Chinese company has officially launched an international multi-center Phase 3 clinical trial. The enrollment of trial patients, and the screening of the first patient has been successfully completed.
The 13th Alzheimer’s Disease Clinical Trial Conference in 2020 will be held online from the 4th to the 7th. On the opening day, Geoffrey Cummings, a professor at the Cleveland Medical Center in the United States, the leading designer and chief scientist of the Phase 3 clinical trial program of the mannite sodium capsule international multi-center clinical trial program, delivered a speech at the meeting and said that mannite sodium capsules have been located in New York, the United States. The Clarity Clinical Research Center in Syracuse successfully completed the first patient screening.
According to Cummings, the enrolled patients will undergo a 52-week multicenter randomized, double-blind double-arm, parallel-group placebo-controlled, single-agent clinical trial. After the double-blind period, a 26-week open trial will be carried out. According to the plan, one-fifth of clinical trial patients will be recruited in the next 6 months.
This international phase 3 clinical trial will involve 2,046 patients with mild to moderate Alzheimer’s disease in 14 countries, of which 40% are from China, and 30% are from North America and Europe.
Cummings said that compared with the previous phase 3 clinical trial in China, the international clinical trial design has extended the double-blind trial period from 9 months to 12 months, which will help to further verify that Ganlut Sodium Capsules are effective for patients. The persistence of the drug effect of cognitive function improvement.
The U.S. Food and Drug Administration approved Shanghai Green Valley Pharmaceutical Co., Ltd., the research and development company of mannite sodium capsules, to carry out an international multi-center phase 3 clinical trial of the drug on April 3 this year.
Ganlut Sodium Capsules has completed phase 3 clinical trials in China and was conditionally approved for marketing in China in 2019 for the treatment of patients with mild to moderate Alzheimer’s disease.