The purpose of this study is to determine whether daily resveratrol therapy can delay or alter the deterioration of memory and daily functioning in people with probable Alzheimer's disease.
| Min Age | Max Age | Gender | Healthy Volunteers |
|---|---|---|---|
50 Years | N/A | Both | No |
Resveratrol is derived from plants and is found in highest levels in red wine and the skin of red grapes. A recent study 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. It may also affect regulatory pathways of diseases of aging, including Alzheimer's disease.
In this study, 120 participants with mild to moderate dementia due to probable Alzheimer's will be randomly assigned to treatment with either resveratrol starting at 500 mg once daily or matching placebo for 12 months. The dose will be increased at 13-week intervals to a maximum of 1 gram twice daily. Participants will undergo venous blood draws for biomarker analysis at baseline and at 52 weeks; participants will also undergo two lumbar punctures for biomarker analyses of cerebrospinal fluid (CSF) at baseline and at week 52. Participants will undergo magnetic resonance imaging (MRI) to measure rate of whole-brain and regional atrophy at screening, week 13, and week 52 visits.
A small group of 15 participants will be asked to take part in a more detailed 24-hour pharmacokinetic substudy that will measure resveratrol levels over a 24-hour period. Blood samples will be collected at 15 different time points. This 24-hour pharmacokinetic sampling in the subgroup will occur after the first dose following baseline, after the first dose at each dose increment (weeks 13, 26 and 39), and after the final dose (week 52).
| Map Marker | City | State | Zip Code | Status | Primary Contact | |
|---|---|---|---|---|---|---|
Geolocation is 33.4636012, -112.0535987 | BannerHealth Alzheimer’s Institute | Phoenix | Arizona | 85006 | Recruiting | |
Geolocation is 33.6471239, -117.8421325 | University of California, Irvine | Irvine | California | 92697 | Recruiting | |
Geolocation is 32.84722, -117.27333 | University of California, San Diego | La Jolla | California | 92037 | Recruiting | |
Geolocation is 34.0502898, -118.2117257 | University of Southern California | Los Angeles | California | 90033 | Recruiting | |
Geolocation is 41.3052226, -72.9268626 | Yale University | New Haven | Connecticut | 06510 | Recruiting | |
Geolocation is 38.9079086, -77.0716829 | Howard University | Washington | District of Columbia | 20060 | Recruiting | |
Geolocation is 38.9178427, -77.0218255 | Georgetown University | Washington | District of Columbia | 20057 | Recruiting | |
Geolocation is 30.2606613, -81.460856 | Mayo Clinic, Jacksonville | Jacksonville | Florida | 32224 | Recruiting | |
Geolocation is 28.0869646, -82.4698603 | USF Health Byrd Alzheimer’s Institute | Tampa | Florida | 33613 | Recruiting | |
Geolocation is 41.8816606, -87.6926257 | Rush University Memory Clinic | Chicago | Illinois | 60612 | Recruiting | |
Geolocation is 39.0313154, -94.6347041 | University of Kansas | Lawrence | Kansas | 66045 | Recruiting | |
Geolocation is 38.0369642, -84.5379455 | University of Kentucky | Lexington | Kentucky | 40504 | Recruiting | |
Geolocation is 39.2713976, -76.5603828 | Johns Hopkins University | Baltimore | Maryland | 21224 | Recruiting | |
Geolocation is 42.2808256, -83.7430378 | University of Michigan | Ann Arbor | Michigan | 48105 | Recruiting | |
Geolocation is 44.0557303, -92.5253639 | Mayo Clinic, Rochester | Rochester | Minnesota | 55905 | Recruiting | |
Geolocation is 36.1922841, -115.1592718 | Cleveland Clinic Lou Ruvo Center | Las Vegas | Nevada | 89106 | Recruiting | |
Geolocation is 40.8409822, -73.9447994 | Columbia University | New York | New York | 10032 | Recruiting | |
Geolocation is 40.7916407, -73.9447994 | Mount Sinai School of Medicine | New York | New York | 10029 | Recruiting | |
Geolocation is 40.74727, -73.9800645 | New York University Medical Center | New York | New York | 10016 | Recruiting | |
Geolocation is 43.1301942, -77.6020569 | University of Rochester | Rochester | New York | 14620 | Recruiting | |
Geolocation is 41.4644979, -81.5087322 | Case Western Reserve University | Cleveland | Ohio | 441206 | Recruiting | |
Geolocation is 39.9583587, -75.1953934 | University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | Recruiting | |
Geolocation is 32.9221152, -80.0367259 | Medical University of South Carolina | N. Charleston | South Carolina | 29406 | Recruiting | |
Geolocation is 32.8113367, -96.8397899 | University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | Recruiting | |
Geolocation is 29.7050857, -95.4018087 | Baylor College of Medicine | Houston | Texas | 77030 | Recruiting | |
Geolocation is 47.5405059, -122.3045438 | University of Washington | Seattle | Washington | 98108 | Recruiting |
| Agency |
|---|
Alzheimer's Disease Cooperative Study (ADCS) |
| Agency |
|---|
National Institute on Aging (NIA) |
| Name | Role | Affiliation |
|---|---|---|
Raymond S. Turner, MD, PhD | Study Director | Georgetown University |
| Name | Phone | |
|---|---|---|
Jeffree Itrich | 858-246-1317 |