Chinese Alzheimer's Drug to Launch Global Trials Amid Skepticism

A newly approved Chinese medication for Alzheimer's will start American and European clinical trials in 2020, reports Bloomberg News . Shanghai Green Valley Pharmaceutical intends to enroll some 2,046 participants with mild-to-moderate Alzheimer's for trials at 200 sites across North America, Europe, and Asia Pacific for 18 months. Oligomannate received conditional approval in China in November, and it went on sale on Dec. 29. Users must take three 15-mg capsules twice daily, and a week's supply costs $128. Skepticism is rife with Green Valley attaining approval for clinical trials so rapidly, and conditional approval requires the drugmaker to conduct further studies on Oligomannate's functionality and long-term safety and effectiveness. Green Valley also plans to invest $3 billion in the next decade on research — including global trials — to understand the drug's working mechanism and expand its use in treating diseases like Parkinson's and vascular dementia. Sanford C. Bernstein & Co. analysts suggested a roughly $30 billion American market alone for successful anti-Alzheimer's drugs. Despite Green Valley's ambitions to fast-track the drug for trials, University of Waterloo epidemiologist Mark Oremus said the company's phase III trial was "far too short to evaluate the medium- to long-term effects," and also neglected to compare the drug with other existing medications.