NCT00743743

Pilot Study of the Effects of Resveratrol Supplement in Mild-to-moderate Alzheimer's Disease

Randomized, Placebo-controlled Clinical Trial of Resveratrol Supplement Effects on Cognition, Function and Behavior in Patients With Mild-to-moderate Alzheimer's Disease

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: All
• Age: 50 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Objective: To determine the effects of resveratrol extract given in a 215 mg dose in a daily supplement currently available over the counter, on cognitive and global functioning in patients with mild to moderate AD on standard therapy.

Detailed description

Background: Many animal and in vitro studies have shown that resveratrol, a naturally occurring polyphenol found in red wine, can increase cognition, reduce neural degeneration, promote clearance of amyloid-beta peptides, and alter aging mechanisms. Therefore, resveratrol may reduce the symptoms of Alzheimer's disease (AD) and possibly its pathology. Objective: A pilot study to determine the effects of resveratrol on cognitive, behavioral and global functioning in patients with mild-to-moderate AD on standard therapy. Design: Randomized, double-blind, placebo-controlled clinical trial. Participants: 50 patients with mild-moderate Alzheimer's disease (AD) defined as a Mini-Mental State Exam (MMSE) between 10-27 will be enrolled in the study. Patients must have an established diagnosis of AD by NINCDS diagnostic criteria, be on stable dose of cognitive enhancing medications (cholinesterase inhibitor and/or NMDA receptor antagonist) Screening/Enrollment: Institutional Review Board approval will be obtained. The chart review and the enrollment discussion will be carried out by a non-physician member of the research team. Participants will be screened and randomized until a total of 50 eligible patients, 25 in each arm are obtained.

Conditions

• Alzheimer Disease

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Longevinex brand resveratrol supplement	1 capsule daily for 52 weeks containing 215 mg of resveratrol active ingredient
DIETARY_SUPPLEMENT	placebo	1 capsule of placebo daily for 52 weeks

Timeline

• Start date: 2008-09-01
• Primary completion: 2010-06-01
• Completion: 2010-12-01
• First posted: 2008-08-29
• Last updated: 2015-08-24