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

Chinese University of Hong Kong36 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Alzheimer's Disease

Interventions

Placebo and ginkgo extractDRUG

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.

Curcumin and ginkgo extractDRUG

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.

Curcumin and ginkgo extractDRUG

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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

Locations (1)

The Chinese University of Hong Kong

Shatin, Hong Kong

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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