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Ginkgo Dementia Prevention Trial Will Be Funded With $15 Mil.

This article was originally published in The Tan Sheet

Executive Summary

The NIH National Center for Complementary and Alternative Medicine and the National Institute on Aging are inviting applications for a study in the prevention of cognitive dementia in older people that will be supported with up to $15 mil.

The NIH National Center for Complementary and Alternative Medicine and the National Institute on Aging are inviting applications for a study in the prevention of cognitive dementia in older people that will be supported with up to $15 mil.

The RFA (AT 99-001) is for a two-arm, double-blind, randomized, placebo-controlled, multi-site trial "to assess...whether ginkgo biloba prevents the occurrence of dementia and/or cognitive decline in older individuals."

The RFA points out if ginkgo "is found effective, then thousands of individuals at high risk of developing dementia will have an inexpensive and safe prevention option. However," the document notes, "if the extract is ineffective as a prevention agent, these data will provide important information to the U.S. public and allow for informed decision-making concerning continued use of the botanical."

The study also will be funded by the National Institute of Neurological Disorders & Stroke, the National Institute of Mental Health and the National Institute for Nursing Research, according to budget documents prepared for congressional appropriations committees ("The Tan Sheet" March 8, p. 7).

A meta-analysis of four studies published in the Nov. 11 Journal of the American Medical Association by Oken et al. concluded gingko has a "small but significant effect" on cognitive function in Alzheimer's ("The Tan Sheet" Nov. 16, 1998, p. 15). A study published in 1997 also showed positive effects of the herbal on dementia ("The Tan Sheet" Oct. 27, 1997, p. 16)

The number of enrollees in the trial will be determined by the final protocol. The trial likely will include patients up to 75 years who can have mild existing cognitive deficits and who will take 240 mg of ginkgo or placebo for a minimum of three years. The primary outcome will be onset of any type of dementia.

The total study period cannot exceed seven years, and the award date for the project is expected to be Sept. 30. Applications must be received by May 21.

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