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Resveratrol for Alzheimer's Disease

  • No longer recruiting

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

++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
BannerHealth Alzheimer’s Institute Phoenix Arizona 85006 Recruiting Clinical Trials Staff
University of California, Irvine Irvine California 92697 Recruiting Catherine McAdams-Ortiz
University of California, San Diego La Jolla California 92037 Recruiting Jennifer Foster
University of Southern California Los Angeles California 90033 Recruiting Mauricio Becerra
Yale University New Haven Connecticut 06510 Recruiting Allison Wagner
Howard University Washington District of Columbia 20060 Recruiting Oludolapo Ogunlana
Georgetown University Washington District of Columbia 20057 Recruiting Daniel Santos
Mayo Clinic, Jacksonville Jacksonville Florida 32224 Recruiting Dana Kistler
USF Health Byrd Alzheimer’s Institute Tampa Florida 33613 Recruiting Kelly Blackmer
Rush University Memory Clinic Chicago Illinois 60612 Recruiting Vidya Chakravarthy
University of Kansas Lawrence Kansas 66045 Recruiting Becky Bothwell
University of Kentucky Lexington Kentucky 40504 Recruiting Heather Nichols
Johns Hopkins University Baltimore Maryland 21224 Recruiting Julia Pedroso
University of Michigan Ann Arbor Michigan 48105 Recruiting Joanne Lord
Mayo Clinic, Rochester Rochester Minnesota 55905 Recruiting Sara Mason
Cleveland Clinic Lou Ruvo Center Las Vegas Nevada 89106 Recruiting Jane dela Cruz-Lobb
Columbia University New York New York 10032 Recruiting Ruth Tejeda
Mount Sinai School of Medicine New York New York 10029 Recruiting Helene Geramian
New York University Medical Center New York New York 10016 Recruiting Dana Pogorelec
University of Rochester Rochester New York 14620 Recruiting Bonnie Goldstein
Case Western Reserve University Cleveland Ohio 441206 Recruiting Susie Sami
University of Pennsylvania Philadelphia Pennsylvania 19104 Recruiting Patricia Martinez
Medical University of South Carolina N. Charleston South Carolina 29406 Recruiting Marie Corbin
University of Texas Southwestern Medical Center Dallas Texas 75390 Recruiting Jacqueline Rabb
Baylor College of Medicine Houston Texas 77030 Recruiting Gerard Duncan
University of Washington Seattle Washington 98108 Recruiting Anita Ranta

Alzheimer's Disease Cooperative Study (ADCS)

  • National Institute on Aging (NIA) - NIH

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

Name Phone Extension Email
Jeffree Itrich 858-246-1317

Resveratrol for Alzheimer`s Disease