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

Phase 3

Withdrawn

• Conditions: Alzheimer Disease
• Interventions: Dietary Supplement: placebo; Dietary Supplement: Longevinex brand resveratrol supplement

• Registration Number: NCT00743743
• Lead Sponsor: Medical College of Wisconsin

Brief 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.

Study Timeline

• Study First Submitted: 2008-08-27
• Study First Submitted QC: 2008-08-28
• Study First Posted: 2008-08-29
• Study Start: 2008-09
• Primary Completion: 2010-06
• Study Completion: 2010-12
• Status Verified: 2015-08
• Last Update Submitted: 2015-08-21
• Last Update Posted: 2015-08-24

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	placebo	Receive 1 capsule daily for 52 weeks containing placebo for comparison to experimental arm
1	Longevinex brand resveratrol supplement	receive 1 Longevinex brand capsule daily containing 215 mg of resveratrol active ingredient

Primary Outcome Measures

Name	Time	Method
cognition	52 weeks

Secondary Outcome Measures

Name	Time	Method
function	52 weeks
behavior	52 weeks