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Resveratrol for Alzheimer's Disease

Completed

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.

Minimum Age Maximum Age Gender Healthy Volunteers
50 Years N/A Both No
May 2012
September 2014
120

++Diagnosis of probable Alzheimer's disease (NINDS-ADRDA criteria)++Age 50 years or older++Able to ingest oral medications++Caregiver/Study Partner who has direct contact with the participant more than 2 days per week to accompany participant to all visits++MMSE score between 14 and 26 (inclusive)++Modified Hachinski score of less than or equal to 4++Able to abstain from ingesting large quantities of resveratrol-containing foods (including red wine); 1-2 glasses of red wine or red grape juice daily acceptable; 1 serving of red grapes daily acceptable++Able to abstain from ingesting herbal/natural preparations or dietary supplements containing resveratrol

++Non-Alzheimer's dementia or probable Alzheimer's disease with Down syndrome++History of clinically significant stroke++Current evidence or history in past 2 years of epilepsy, focal brain lesion, head injury with loss of consciousness, or any major psychiatric disorder++Sensory impairment that would preclude the participant from participating in or cooperating with the protocol++Use of investigational agent within 2 months prior to screening++Significant clinical disorder or laboratory finding that renders the participant unsuitable for receiving an investigational drug, including clinically significant or unstable hematologic, hepatic, cardiovascular, pulmonary, gastrointestinal, endocrine, metabolic, renal, or other systemic disease or laboratory abnormality++Active neoplastic disease, history of cancer within 5 years prior to screening (skin melanoma or stable prostate cancer is allowable)++History of seizure within past 5 years++Pregnancy or possible pregnancy

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).

Name City State Zip Status Primary Contact
Banner Alzheimer's Institute
Phoenix Arizona 85006

University of California, Irvine
Irvine California 92697

University of California, San Diego - Comprehensive Alzheimer's Program
La Jolla California 92037

University of Southern California
Los Angeles California 90033

Yale University
New Haven Connecticut 06510

Georgetown University
Washington District of Columbia 20057

Howard University
Washington District of Columbia 20060

Mayo Clinic, Jacksonville
Jacksonville Florida 32224

University of South Florida
Tampa Florida 33613

Rush University Medical Center
Chicago Illinois 60612

University of Kansas
Kansas City Kansas 66205

University of Kentucky
Lexington Kentucky 40504

Johns Hopkins University
Baltimore Maryland 21224

University of Michigan
Ann Arbor Michigan 48105

Mayo Clinic, Rochester
Rochester Minnesota 55905

Cleveland Clinic Lou Ruvo Center for Brain Health
Las Vegas Nevada 89106

New York University
New York New York 10016

Mount Sinai School of Medicine
New York New York 10029

Columbia University
New York New York 10032

University of Rochester Medical Center
Rochester New York 14620

Case Western Reserve University
Beachwood Ohio 44122

University of Pennsylvania
Philadelphia Pennsylvania 19104

Medical University of South Carolina
N. Charleston South Carolina 29406

University of Texas Southwestern Medical Center
Dallas Texas 75390

Baylor College of Medicine
Houston Texas 77030

U of WA / VA Puget Sound Alzheimer's Disease Research Center
Seattle Washington 98108

Alzheimer's Disease Cooperative Study (ADCS)

  • National Institute on Aging (NIA)

Name Role Affiliation
Raymond S. Turner, MD, PhD Study Director Georgetown University

Name Phone Email
Jeffree Itrich 858-246-1317 jitrich@ucsd.edu

NCT01504854

Resveratrol for Alzheimer's Disease