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

The Chinese University of Hong Kong

Status and phase: Completed; Phase 2; Phase 1

Conditions: Alzheimer's Disease

Treatments: Drug: Placebo and ginkgo extract; Drug: Curcumin and ginkgo extract

Study type: Interventional

Funder types: Other

Identifiers

NCT00164749

CRE-2003.090-T

Details and patient eligibility

About

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

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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36 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Color-matched placebo

Treatment:

Drug: Placebo and ginkgo extract

1 gram

Experimental group

Description:

1 g/day curcumin

Treatment:

Drug: Curcumin and ginkgo extract

Drug: Curcumin and ginkgo extract

4 gram

Experimental group

Description:

4 g/day curcumin

Treatment:

Drug: Curcumin and ginkgo extract

Drug: Curcumin and ginkgo extract