Alzheimer's Disease Education and Referral Center

Resveratrol for Alzheimer's Disease

Resveratrol for Alzheimer's Disease

Overall Status: 
No longer recruiting
Brief Description: 

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.

Patient Qualifications: 
Min AgeMax AgeGenderHealthy Volunteers
50 Years
N/A
Both
No
Inclusion Criteria: 

  • 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

Exclusion Criteria: 

  • 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

Detailed Description: 

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).

Locations: 
Map Marker CityStateZip CodeStatusPrimary Contact

Geolocation is 33.4636012, -112.0535987

BannerHealth Alzheimer’s Institute
Phoenix
Arizona
85006
Recruiting
Clinical Trials Staff
602-839-6279
BAInfo@bannerhealth.com

Geolocation is 33.6471239, -117.8421325

University of California, Irvine
Irvine
California
92697
Recruiting
Catherine McAdams-Ortiz
949-824-8726
cmcadams@uci.edu

Geolocation is 32.84722, -117.27333

University of California, San Diego
La Jolla
California
92037
Recruiting
Jennifer Foster
858-246-1306
jrfoster@ucsd.edu

Geolocation is 34.0502898, -118.2117257

University of Southern California
Los Angeles
California
90033
Recruiting
Mauricio Becerra
323-442-7594
mjbecerr@usc.edu

Geolocation is 41.3052226, -72.9268626

Yale University
New Haven
Connecticut
06510
Recruiting
Allison Wagner
203-764-8100
allison.wagner@yale.edu

Geolocation is 38.9079086, -77.0716829

Howard University
Washington
District of Columbia
20060
Recruiting
Oludolapo Ogunlana
202-865-3776
oogunlana@howard.edu

Geolocation is 38.9178427, -77.0218255

Georgetown University
Washington
District of Columbia
20057
Recruiting
Daniel Santos
202-687-0413
ds1238@georgetown.edu

Geolocation is 30.2606613, -81.460856

Mayo Clinic, Jacksonville
Jacksonville
Florida
32224
Recruiting
Dana Kistler
904-953-8035
kistler.dana@mayo.edu

Geolocation is 28.0869646, -82.4698603

USF Health Byrd Alzheimer’s Institute
Tampa
Florida
33613
Recruiting
Kelly Blackmer
813-974-4355
kblackme@health.usf.edu

Geolocation is 41.8816606, -87.6926257

Rush University Memory Clinic
Chicago
Illinois
60612
Recruiting
Vidya Chakravarthy
312-563-4111
Vidya_Chakravarthy@rush.edu

Geolocation is 39.0313154, -94.6347041

University of Kansas
Lawrence
Kansas
66045
Recruiting
Becky Bothwell
913-945-5033
rbothwell@kumc.edu

Geolocation is 38.0369642, -84.5379455

University of Kentucky
Lexington
Kentucky
40504
Recruiting
Heather Nichols
859-323-1331
hdnich2@email.uky.edu

Geolocation is 39.2713976, -76.5603828

Johns Hopkins University
Baltimore
Maryland
21224
Recruiting
Julia Pedroso
410-550-9022
jpedroso@jhmi.edu

Geolocation is 42.2808256, -83.7430378

University of Michigan
Ann Arbor
Michigan
48105
Recruiting
Joanne Lord
734-647-7760
lord@umich.edu

Geolocation is 44.0557303, -92.5253639

Mayo Clinic, Rochester
Rochester
Minnesota
55905
Recruiting
Sara Mason
507-293-4711
Mason.Sara@mayo.edu

Geolocation is 36.1922841, -115.1592718

Cleveland Clinic Lou Ruvo Center
Las Vegas
Nevada
89106
Recruiting
Jane dela Cruz-Lobb
702-483-6026
delaj@ccf.org

Geolocation is 40.8409822, -73.9447994

Columbia University
New York
New York
10032
Recruiting
Ruth Tejeda
212-305-7661
rbt41@columbia.edu

Geolocation is 40.7916407, -73.9447994

Mount Sinai School of Medicine
New York
New York
10029
Recruiting
Helene Geramian
646-284-7547
helene.geramian@mssm.edu

Geolocation is 40.74727, -73.9800645

New York University Medical Center
New York
New York
10016
Recruiting
Dana Pogorelec
212-263-5708
dana.pogorelec@nyumc.org

Geolocation is 43.1301942, -77.6020569

University of Rochester
Rochester
New York
14620
Recruiting
Bonnie Goldstein
585-760-6562
Bonnies_goldstein@urmc.rochester.edu

Geolocation is 41.4644979, -81.5087322

Case Western Reserve University
Cleveland
Ohio
441206
Recruiting
Susie Sami
216-464-6467
susie.sami@case.edu

Geolocation is 39.9583587, -75.1953934

University of Pennsylvania
Philadelphia
Pennsylvania
19104
Recruiting
Patricia Martinez
215-615-3084
patricia.martinez@uphs.upenn.edu

Geolocation is 32.9221152, -80.0367259

Medical University of South Carolina
N. Charleston
South Carolina
29406
Recruiting
Marie Corbin
843-740-1592
corbinm@musc.edu

Geolocation is 32.8113367, -96.8397899

University of Texas Southwestern Medical Center
Dallas
Texas
75390
Recruiting
Jacqueline Rabb
214-648-9376
jackie.rabb@utsouthwestern.edu

Geolocation is 29.7050857, -95.4018087

Baylor College of Medicine
Houston
Texas
77030
Recruiting
Gerard Duncan
713-798-5325
gjduncan@bcm.edu

Geolocation is 47.5405059, -122.3045438

University of Washington
Seattle
Washington
98108
Recruiting
Anita Ranta
206-764-2339
rantaa@u.washington.edu/
Lead Sponsor: 
Agency
Alzheimer's Disease Cooperative Study (ADCS)
Collaborator Sponsor: 
Agency
National Institute on Aging (NIA)
Facility Investigators: 
NameRoleAffiliation
Raymond S. Turner, MD, PhD
Study Director
Georgetown University
Study Contact: 
NamePhoneEmail
Jeffree Itrich
858-246-1317
Locations
 
 
ClinicalTrials.gov ID 
NCT01504854 (follow link to view full record on ct.gov in new window)
Official Title: 
Resveratrol for Alzheimer's Disease
Study Start Date: 
May 2012
Study End Date: 
September 2014
Disease Stage: 
Early
Middle
Enrollment: 
120