Resveratrol for Alzheimer's Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Alzheimer's Disease

In brief

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 and may affect regulatory pathways of diseases of aging, including Alzheimer's disease (AD). In this study, people with AD will be given either Resveratrol or placebo for 12 months to determine whether daily resveratrol therapy is beneficial in delaying or altering the deterioration of memory and daily functioning. Subjects age 50 and above with a diagnosis of probable AD may qualify for participation in this study. A small group of 15 participants will be asked to take part in a more detailed 24-hour Pharmacokinetic (PK) sub-study that will measure resveratrol levels over a 24 hour period.

Key facts

Study ID

NCT01504854

Run by

Alzheimer's Disease Cooperative Study (ADCS)

People needed

119

Starts

2012-05-01

Expected to finish

2014-03-01

Last updated by the study team

2016-06-14

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of probable AD (NINDS-ADRDA criteria).
• Age must be 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.

You may not qualify if…

• Non-AD dementia.
• Probable AD with Down syndrome.
• History of clinically significant stroke.
• Current evidence or history in past two years of epilepsy, focal brain lesion, head injury with loss of consciousness or DSM-IV criteria for any major psychiatric disorder including psychosis, major depression, bipolar disorder, alcohol or substance abuse.
• Sensory impairment that would preclude the participant from participating in or cooperating with the protocol.
• Use of investigational agent within two months of Screening.
• Evidence of any 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 five years prior to screening, including breast cancer (history or skin melanoma or stable prostate cancer are not excluded).
• History of seizure within past five years.
• Pregnancy or possible pregnancy.
• Use of resveratrol containing supplements.

Where it is running

• Banner Alzheimer's Institute — Phoenix, Arizona, United States
• University of California, Irvine — Irvine, California, United States
• University of California, San Diego - Comprehensive Alzheimer's Program — La Jolla, California, United States
• University of Southern California — Los Angeles, California, United States
• Yale University — New Haven, Connecticut, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Howard University — Washington D.C., District of Columbia, United States
• Mayo Clinic, Jacksonville — Jacksonville, Florida, United States
• University of South Florida — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• University of Kansas — Kansas City, Kansas, United States
• University of Kentucky — Lexington, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic, Rochester — Rochester, Minnesota, United States
• Cleveland Clinic Lou Ruvo Center for Brain Health — Las Vegas, Nevada, United States
• New York University — New York, New York, United States
• Mount Sinai School of Medicine — New York, New York, United States
• Columbia University — New York, New York, United States
• University of Rochester Medical Center — Rochester, New York, United States
• Case Western Reserve University — Beachwood, Ohio, United States
• University of Pennsylvania — Philadelphia, Pennsylvania, United States
• Medical University of South Carolina — North Charleston, South Carolina, United States
• University of Texas Southwestern Medical Center — Dallas, Texas, United States
• Baylor College of Medicine — Houston, Texas, United States

Full record on ClinicalTrials.gov

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