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|
++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).
|BannerHealth Alzheimer’s Institute||Phoenix||Arizona||85006||Recruiting||
Clinical Trials Staff
|University of California, Irvine||Irvine||California||92697||Recruiting||
|University of California, San Diego||La Jolla||California||92037||Recruiting||
|University of Southern California||Los Angeles||California||90033||Recruiting||
|Yale University||New Haven||Connecticut||06510||Recruiting||
|Howard University||Washington||District of Columbia||20060||Recruiting||
|Georgetown University||Washington||District of Columbia||20057||Recruiting||
|Mayo Clinic, Jacksonville||Jacksonville||Florida||32224||Recruiting||
|USF Health Byrd Alzheimer’s Institute||Tampa||Florida||33613||Recruiting||
|Rush University Memory Clinic||Chicago||Illinois||60612||Recruiting||
|University of Kansas||Lawrence||Kansas||66045||Recruiting||
|University of Kentucky||Lexington||Kentucky||40504||Recruiting||
|Johns Hopkins University||Baltimore||Maryland||21224||Recruiting||
|University of Michigan||Ann Arbor||Michigan||48105||Recruiting||
|Mayo Clinic, Rochester||Rochester||Minnesota||55905||Recruiting||
|Cleveland Clinic Lou Ruvo Center||Las Vegas||Nevada||89106||Recruiting||
Jane dela Cruz-Lobb
|Columbia University||New York||New York||10032||Recruiting||
|Mount Sinai School of Medicine||New York||New York||10029||Recruiting||
|New York University Medical Center||New York||New York||10016||Recruiting||
|University of Rochester||Rochester||New York||14620||Recruiting||
|Case Western Reserve University||Cleveland||Ohio||441206||Recruiting||
|University of Pennsylvania||Philadelphia||Pennsylvania||19104||Recruiting||
|Medical University of South Carolina||N. Charleston||South Carolina||29406||Recruiting||
|University of Texas Southwestern Medical Center||Dallas||Texas||75390||Recruiting||
|Baylor College of Medicine||Houston||Texas||77030||Recruiting||
|University of Washington||Seattle||Washington||98108||Recruiting||
- National Institute on Aging (NIA) - NIH
|Raymond S. Turner, MD, PhD||Study Director||Georgetown University|
- Vang O, Ahmad N, Baile CA, Baur JA, Brown K, Csiszar A, Das DK, Delmas D, Gottfried C, Lin HY, Ma QY, Mukhopadhyay P, Nalini N, Pezzuto JM, Richard T, Shukla Y, Surh YJ, Szekeres T, Szkudelski T, Walle T, Wu JM. What is new for an old molecule? Systematic review and recommendations on the use of resveratrol. PLoS One. 2011;6(6):e19881. Epub 2011 Jun 16. Review.
- Smoliga JM, Baur JA, Hausenblas HA. Resveratrol and health--a comprehensive review of human clinical trials. Mol Nutr Food Res. 2011 Aug;55(8):1129-41. Epub 2011 Jun 20. Review.
- Patel KR, Scott E, Brown VA, Gescher AJ, Steward WP, Brown K. Clinical trials of resveratrol. Ann N Y Acad Sci. 2011 Jan;1215:161-9. Review.
- Timmers S, Konings E, Bilet L, Houtkooper RH, van de Weijer T, Goossens GH, Hoeks J, van der Krieken S, Ryu D,