A Phase 1/2 interventional study of Placebo and ginkgo extract and Curcumin and ginkgo extract in Alzheimer's Disease, sponsored by Chinese University of Hong Kong. Completed at 1 site in Hong Kong. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2008-04-30.
Sponsored by Chinese University of Hong Kong · Phase 1/2, Interventional, and Treatment
The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression.
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.
3,678 studies on the registry are indexed under Alzheimer Disease; 872 are open to participants now.
This study's enrollment of 36 is below the median of 70 across 2,808 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Chinese University of Hong Kong is the lead sponsor of 1,419 studies on the registry; 487 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Color-matched placebo
Drug: Placebo and ginkgo extract
1 g/day curcumin
Drug: Curcumin and ginkgo extract
4 g/day curcumin
Drug: Curcumin and ginkgo extract
Placebo once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
1 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
4 g curcumin once daily, either as capsules or as powder to be mixed with food. All patients also received 120 mg/day standardized ginkgo leaf extract.
Change in isoprostane level in plasma
Time frame: 1 and 6 months
Change in A-beta level in serum
Time frame: 1 and 6 months
Change in cognitive function (MMSE score)
Time frame: 6 months
Change in cholesterol and triglycerides in serum
Time frame: 1 and 6 months
Change in metals in serum
Time frame: 1 month
Level of curcumin in plasma vs. dose
Time frame: 1 month
This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.
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Chinese University of Hong Kong