Dementia Prevention Study Collaboration

KARLSRUHE, Germany, 12 July 2000.

In a significant move towards starting up the previously announced multicenter dementia study on the herbal dietary supplement, Ginkgo biloba, the National Institutes of Health (NIH) have confirmed a collaboration agreement with the Dr. Willmar Schwabe company (Schwabe) of Karlsruhe, Germany to provide the product to be used in the study.

Last fall, the NIH announced a million award for a major multicenter study to test the effectiveness of Ginkgo biloba extract in preventing dementia in aging individuals. The award, by two groups within NIH, the National Center for Complementary and Alternative Medicine (NCCAM) and the National Institute on Aging (NIA), was given to the University of Pittsburgh School of Medicine to coordinate the study with 3 further nationally renowned medical centers. Steven T. DeKosky, M.D., Professor of Psychiatry, Neurology and Neurobiology, and Director of the Alzheimer's Disease Research Center at the University of Pittsburgh School of Medicine will serve as the principal investigator of the study referred to as the "Ginkgo Evaluation of Memory (GEM) study".

The six-year study will enroll a total of 3,000 participants who will be randomly assigned to one of two groups. One group of participants will take 240 mg. of Ginkgo biloba extract and will be compared to a second group who will take a placebo. Having made a careful assessment of different available Ginkgo products, NIH / NCCAM recently made the decision to conduct the study using the original extract developed and manufactured by Schwabe with the designator code EGb 761®. An agreement has now been signed between the NCCAM and Schwabe under which Schwabe will supply the total trial requirements of about 12 million tablets free of charge (estimated market value approx. name="content4" caption="Keyvisual" wEditorTagName="wd:group" million). "This represents a far larger tablet quantity than provided for any previous clinical trial involving Ginkgo" said Karl-Heinz Stumpf, General Manager, Research & Development at Schwabe "but we are very happy to be able to support such an important investigation by supplying the NIH with the world's best studied Ginkgo extract".

The first clinical study of Ginkgo biloba and dementia in the United States was also conducted using Schwabe's EGb 761® extract. Researchers at the New York Institute for Medical Research in Tarrytown, New York examined how taking just 120 mg a day affected the rate of cognitive decline in older individuals with mild to moderately severe dementia due to Alzheimer's disease and vascular dementia. The results of this study were published in the Journal of the American Medical Association (October 22/29, 1997), and suggest that EGb 761® may be of help in treating symptoms of Alzheimer's disease and vascular dementia. Another clinical study in the treatment of Alzheimer's dementia is currently ongoing at more than 40 centers in the United States, again sponsored by Schwabe.

Schwabe's EGb 761® is a specially processed extract, which complies with all requirements of the WHO monograph for Ginkgo biloba including the 5 ppm upper limit for ginkgolic acids. The EGb 761® extract has been uniquely subjected to wide ranging clinical study over the past 25 years, primarily in Europe. It is on the basis of these published studies as well as extensive pre-clinical research that the extract has received approved drug status in more than 70 countries worldwide.

With a history of dedication to plant based medicines spanning over 130 years, Schwabe is one of the oldest registered pharmaceutical companies in Germany. The company was founded in 1866 by the pharmacist Dr. Willmar Schwabe who set up a research institute to "examine plant medicines for authenticity and purity and to establish appropriate norms for their characteristic and active substances". Today, according to independent industry market data, Schwabe is the leading manufacturer of phytomedicines worldwide. In the USA, Schwabe is best known through its association with Nature's Way of Springville, Utah. Nature's Way is the main marketing and distribution arm of Murdock Madaus Schwabe Inc. (MMS) in which Schwabe recently increased its shareholding to 50% with the aim of strengthening the company's US presence.

The mission of the NIH National Center for Complementary and Alternative Medicine (NCCAM) is to conduct and support basic and applied research and research training and disseminate evidenced-based information on complementary and alternative medical practices to health professionals and the public. For more information about NCCAM-sponsored research and activities, contact the NCCAM's Clearinghouse at 1-888-644-6226 or visit the NCCAM's web site at nccam.nih.gov.

The National Institute on Aging (NIA) is the lead federal agency supporting and conducting Alzheimer's disease research, including studies of the basic, clinical, and epidemiological aspects of this and other related dementias of aging. For more information, contact NIA's Alzheimer's Disease Education & Referral (ADEAR) Center at 1-800-438-4380 or visit its website at www.alzheimers.org.

EGb 761® is a trademark of the Dr. Willmar Schwabe Company of Karlsruhe, Germany.

For more information visit the website of The Ginkgo Evaluation of Memory Study.