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临床试验/NCT00164749
NCT00164749已完成1 期

A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2004年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
入组人数
36
试验地点
1
主要终点
Change in isoprostane level in plasma

研究概览

简要总结

The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression.

详细描述

A double-blind, randomized, clinical trial of 30 subjects will be carried out to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression. Curcumin is a polyphenolic molecule extracted from turmeric and is widely and safely used as a yellow food coloring. Because of its strong anti-inflammatory activity, curcumin was tested in animal models of AD, where it significantly reduced levels of brain amyloid, oxidized proteins, and isoprostanes, and prevented cognitive deficits. AD patients will receive placebo, 1 g, or 4 g of curcumin daily for six months. All patients will also receive 120 mg ginkgo leaf extract daily. At 0, 1, 3, and 6 months of the study, a cognitive test will be performed, and blood samples will be analyzed for levels of isoprostane, amyloid beta protein, metals, and cholesterol. Curcumin and its metabolites will be measured in blood at 1 month. The primary objective for this first human study of curcumin in AD is to examine safety and procedures for a possible larger trial testing curcumin against AD. The secondary objective is to determine whether curcumin affects biochemical measures, and, if so, which dose is most effective. The tertiary objective is to determine whether curcumin slows cognitive decline in AD. This study may lead to inexpensive treatment that delays progression of AD.

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
Double

入排标准

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

入选标准

  • Ethnic Chinese living in Hong Kong
  • Progressive decline in memory and cognitive function for at least 6 months
  • NINCDS-ADRDA diagnosis of possible or probable AD
  • Mild to severe dementia with Cantonese version of MMSE scores between 0 and 28
  • Informed consent from patient and/or caregiver
  • Both elderly home residents and outpatients are eligible
  • Patients may take any medication

排除标准

  • Anticoagulant or antiplatelet treatment or bleeding risk factors
  • Currently smoking
  • Other severe, end-stage illness

研究组 & 干预措施

Placebo

Placebo Comparator

Color-matched placebo

干预措施: Placebo and ginkgo extract (Drug)

1 gram

Experimental

1 g/day curcumin

干预措施: Curcumin and ginkgo extract (Drug)

4 gram

Experimental

4 g/day curcumin

干预措施: Curcumin and ginkgo extract (Drug)

结局指标

主要结局

Change in isoprostane level in plasma

时间窗: 1 and 6 months

Change in A-beta level in serum

时间窗: 1 and 6 months

次要结局

  • Change in cognitive function (MMSE score)(6 months)
  • Change in cholesterol and triglycerides in serum(1 and 6 months)
  • Change in metals in serum(1 month)
  • Level of curcumin in plasma vs. dose(1 month)

研究者

申办方类型
Other

研究点 (1)

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