Resveratrol in Alzheimer’s Disease Study

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This study will be enrolling participants spring 2012.

A Phase II clinical study of Resveratrol (RES) designed to evaluate the safety, tolerability and effectiveness of Resveratrol on cerebrospinal fluid (CSF) and other biomarkers for the treatment of Alzheimer's disease (AD).

Resveratrol is derived from plants and is found in highest levels in red wine and the skin of red grapes. The Copenhagen City Heart Study (Treutlen et al 2002) reported that monthly and weekly consumption of red wine is associated with a lower risk of dementia. There is compelling evidence that caloric restriction can improve overall health by activating a class of enzymes known as Sirtuins. Resveratrol is a substance found in some plants that directly activates sirtuins, mimicking the effects of caloric restriction and may affect regulatory pathways of diseases of aging, including AD.

In this study, people with AD will be given either Resveratrol or placebo (looks like the study drug but contains no active medication) for 12 months to determine whether daily Resveratrol therapy is beneficial in delaying or altering the deterioration of memory and daily functioning. Patients with a diagnosis of probable AD may qualify for participation in this study.

Patients that are eligible and agree to participate will be among 120 people enrolled in the study. The RES study is taking place at about 26 sites across the United States affiliated with the Alzheimer’s Disease Cooperative Study. Each research site will enroll approximately five participants. Participants who are already being treated for AD can continue on their FDA-approved AD treatments (must be on a stable dose for a minimum of 3 months prior to screening for the study). Participants cannot be enrolled in another clinical study during this time. Patient participation will last up to 12 months and will require up to 10 study visits. Some of these visits may be performed over multiple days. This is a double-blind, placebo-controlled study which means that study participants have a 50/50 chance of receiving either Resveratrol or the placebo and neither the site or the participant will know if they are receiving placebo or Resveratrol.

A small group of 15 participants will be asked to take part in a more detailed 24-hour PK analysis sub-study that will measure Resveratrol levels at 15 different time points over a 24 hour period at five different visits..

The U.S. Food and Drug Administration (FDA) has not approved Resveratrol for the treatment of AD and we do not know whether the use of Resveratrol can change the course the disease.

To be eligible for this study participants must:

• Have a diagnosis of probable mild-to-moderate AD
• Age greater or equal to 50
• Be in good general health
• Are fluent in English or Spanish
• Are willing and able to undergo in-clinic assessments, two lumbar punctures to gather cerebral spinal fluid (CSF), three MRIs, and blood and urine tests.
• Have a reliable study partner that can accompany the participant to all study visits and has more than two days a week of contact with the participant.
• Able to abstain from ingesting large quantities of Resveratrol-containing foods, including red wine (one or two glasses of red wine or red grape juice or one serving of red grapes daily is acceptable).
• Able to abstain from ingesting herbal/natural preparations or dietary supplements containing Resveratrol.

Any of the following will exclude participation:

• Significant neurological disease other than AD
• Depression, major psychiatric disorders and behavioral problems
• Alcohol or substance abuse within the last two years
• History of cancer within five years prior to screening (history of skin melanoma or stable prostate cancer are not excluded)
• Any significant systemic illness or unstable medical condition

Participants will be screened at the research sites to determine if they are eligible for the study. To learn how to participate contact one of the above centers or contact the NIA's Alzheimer's Disease Education and Referral (ADEAR) Center at 1-800-438-4380 or by email to adear@nia.nih.gov.

Clinical Study Research Sites Participating in the RES Study: