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临床试验/NCT00743743
NCT00743743撤回3 期

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

Medical College of Wisconsin0 个研究点开始时间: 2008年9月最近更新:
适应症

试验速览

阶段
3 期
状态
撤回
主要终点
cognition

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
50 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

cognition

时间窗: 52 weeks

次要结局

  • function(52 weeks)
  • behavior(52 weeks)

研究者

申办方类型
Other
责任方
Sponsor

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