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

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

Detailed Description
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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.

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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: Placebo and ginkgo extract
* Drug: Curcumin and ginkgo extract
* Drug: Curcumin and ginkgo extract


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Anticoagulant or antiplatelet treatment or bleeding risk factors Currently smoking Other severe, end-stage illness

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Color-matched placebo | Drug: Placebo and ginkgo extract<br>* 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.<br>|
| Experimental: 1 gram<br>1 g/day curcumin | Drug: Curcumin and ginkgo extract<br>* 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.<br>|
| Experimental: 4 gram<br>4 g/day curcumin | Drug: Curcumin and ginkgo extract<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in isoprostane level in plasma |  | 1 and 6 months | 
| Change in A-beta level in serum |  | 1 and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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dementia, cognition, memory, neurodegenerative disease, brain