// News Entry

Fall-Winter 2011

A new clinical trial of a red wine derivative By Judith Neugroschl, M.D.

The Mount Sinai ADRC is excited to announce our participation in a new nationwide study examining the effect of resveratrol in patients with mild to moderate Alzheimer’s disease (AD).  What makes this trial unique is that in addition to the traditional paper and pencil tests, the effects of this medication will be evaluated using MRIs (to assess the size of various areas of the brain), as well as biological markers found in the cerebro-spinal fluid (CSF) that are thought to correlate with AD. CSF is a fluid that surrounds the brain and spinal cord; one function of the CSF is to protect these areas from injury.  CSF is collected using a procedure called a lumbar puncture (or “spinal tap”) — in which a needle is inserted into the lower back and a small amount of the fluid is removed for testing. CSF collection is quickly becoming a standard part of research, as it is the most reliable source for measuring brain metabolism and function.

Resveratrol is derived from plants and is found in high levels in certain red wines and the skin of red grapes. You may have heard that drinking one glass of red wine a day is beneficial for your memory.  There is some evidence to suggest that resveratrol is the reason for this potential benefit.

It appears that resveratrol may have several mechanisms of action related to the development of AD. In the lab, resveratrol protects cells against Abeta/amyloid-induced injury to brain cells. Abeta is a peptide that can clump together to form amyloid plaques in the brain, which is one of the hallmarks of AD.  Furthermore, in the lab, resveratrol lowers the levels of Abeta produced from different types of cells. It also appears to help in the breakdown of Abeta.  In mice, resveratrol decreased the amount of amyloid plaque in the brain.  Resveratrol is also involved in genetic regulation of the aging process, such that it mimics a protein that is known to prolong the lifespan of an organism.  Together, these results are promising; however, a large scale clinical trial examining resveratrol’s potential benefits in people with AD is critically important.

The drug has been tested in healthy men using a single oral dose of up to 1000mg.  It is commercially available in doses up to 700mg, although the actual amount of resveratrol in commercial formulations is unknown, as it is not regulated.  In general, it is categorized as “generally recognized as safe” by the U.S. FDA and the FDA is currently reviewing the study protocol to evaluate the proposed doses.

There was a pilot study examining the effects of resveratrol at Mount Sinai. However, the pilot study used a much lower dose of resveratrol than what is planned for the new study.  Results of the pilot study are almost ready to be analyzed.

The upcoming Resveratrol study will take place over one year, and will require 10 visits, including two lumbar punctures and three MRIs.  This study will evaluate resveratrol’s effect on biomarkers of AD, as well as resveratrol’s effect on brain atrophy.  We are excited to be taking part in this study.  For more information, please contact Helene Geramian at 212-659-8885.

For more information about lumbar punctures, please visit page 6 of  our Fall/Winter 2011 newsletter.

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