The Chinese University of Hong Kong
Shatin, Hong Kong
NCT Number: NCT00164749
The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression.
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Notify Me50 year and older
All sexes
Interventional
Phase 1 / Phase 2
Shatin, Hong Kong
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 1 and 6 months
Time frame: 1 and 6 months
Time frame: 6 months
Time frame: 1 and 6 months
Time frame: 1 month
Time frame: 1 month
Chinese University of Hong Kong
Other
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