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

Phase 1

Completed

• Conditions: Alzheimer's Disease
• Interventions: Drug: Placebo and ginkgo extract; Drug: Curcumin and ginkgo extract

• Registration Number: NCT00164749
• Lead Sponsor: Chinese University of Hong Kong

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-14
• Primary Completion: 2006-07
• Study Completion: 2006-07
• Status Verified: 2008-04
• Last Update Submitted: 2008-04-25
• Last Update Posted: 2008-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo and ginkgo extract	Color-matched placebo
1 gram	Curcumin and ginkgo extract	1 g/day curcumin
4 gram	Curcumin and ginkgo extract	4 g/day curcumin

Primary Outcome Measures

Name	Time	Method
Change in isoprostane level in plasma	1 and 6 months
Change in A-beta level in serum	1 and 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

The Chinese University of Hong Kong; 🇭🇰 Shatin, Hong Kong