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news.Neuro-Hitech has completed the double-blind part of its multi-center, randomized, placebo-controlled Phase II clinical trial of Huperzine A in the treatment of patients with mild to moderate Alzheimer's disease.
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The study involves 210 patients with mild to moderate Alzheimer’s disease (AD). The trial is comparing the safety, tolerability and efficacy of either 200 or 400 micrograms of Huperzine A administered orally twice a day for 16 weeks versus placebo. The trial will measure the efficacy of Huperzine A on cognitive function, activities of daily living and behavior.
Neuro-Hitech expects top-line results from the double-blind part of the study in the first quarter of 2008. At the end of the double-blind part of the study all patients were invited to receive Huperzine A treatment in an open-label fashion for up to one year.
Gary Shearman, president and CEO of Neuro-Hitech, said: “We are very pleased to announce the achievement of this important milestone and look forward to reporting the top-line results in the near future.”