Status:
COMPLETED
Resveratrol for Alzheimer's Disease
Lead Sponsor:
Alzheimer's Disease Cooperative Study (ADCS)
Collaborating Sponsors:
National Institute on Aging (NIA)
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE2
Brief Summary
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 l...
Detailed Description
This double blind, placebo-controlled trial will be conducted at approximately 26 Alzheimer's Disease Cooperative Study (ADCS) clinical centers. One hundred twenty (120) patients with mild to moderate...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2014
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT01504854
Start Date
May 1 2012
End Date
March 1 2014
Last Update
June 14 2016
Active Locations (26)
Enter a location and click search to find clinical trials sorted by distance.
1
Banner Alzheimer's Institute
Phoenix, Arizona, United States, 85006
2
University of California, Irvine
Irvine, California, United States, 92697
3
University of California, San Diego - Comprehensive Alzheimer's Program
La Jolla, California, United States, 92037
4
University of Southern California
Los Angeles, California, United States, 90033