2006-04-29

Researchers from Georgetown University Medical Center's Memory Disorders Program are directing the first U.S. study to determine whether huperzine A, derived from the Chinese club moss plant Huperzia serrata, improves cognitive function in people with Alzheimer's disease (AD). The study, which is recruiting participants at 28 sites across the country, is jointly funded by the National Institutes of Health and Neuro-Hitech Pharmaceuticals, Inc.

Huperzine A, a naturally occurring cholinesterase inhibitor, has been used in Chinese folk medicine for the treatment of fevers and inflammation. Although also commonly used in China to treat Alzheimer's, there have been no controlled clinical trials assessing its toxicity and efficacy outside of China. Chinese studies have suggested that huperzine A is well tolerated and effective.

Paul Aisen, M.D., professor of neurology and leader of the new multi-site study, says huperzine A shows great promise as a treatment for AD. "Based on studies in China, huperzine A may be more effective and better tolerated than currently prescribed drugs for Alzheimer's Disease. In addition, laboratory studies suggest that huperzine may have unique effects that could slow down the progression of the disease."

Huperzine A is currently available in the U.S. and is used by some American physicians to treat A.D. The herb is classified as a nutriceutical by the U.S. Food and Drug Administration, does not require a prescription and is contained in some products sold in health food stores and pharmacies.

The huperzine A study will enroll approximately 150 participants, age 55 or older, with mild to moderate A.D. The trial focuses on individuals who have not found currently approved cholinesterase inhibitors (including Aricept, Reminyl, Exelon or Cognex), effective or tolerable. Cholinesterase inhibitors have been proven to relieve memory impairment and other symptoms associated with A.D.

As a phase II trial, the goal of the new study is to determine safety and efficacy and whether a larger, definitive study should be initiated.

"This trial is essential to better understand the promise of huperzine A," says Dr. Aisen. Though it is a rigorous placebo-controlled trial, all participants do receive the active medication. The first portion of the trial, lasting 16 weeks, includes a placebo arm, but all participants have the opportunity to take active huperzine A for at least 8 months.

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