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Completed

NCT Number: NCT00164749

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

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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Key information

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The Chinese University of Hong Kong

Shatin, Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo and ginkgo extract

Drug

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 extract

Drug

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.

Primary outcomes

  1. Change in isoprostane level in plasma

    Time frame: 1 and 6 months

  2. Change in A-beta level in serum

    Time frame: 1 and 6 months

Secondary outcomes

  1. Change in cognitive function (MMSE score)

    Time frame: 6 months

  2. Change in cholesterol and triglycerides in serum

    Time frame: 1 and 6 months

  3. Change in metals in serum

    Time frame: 1 month

  4. Level of curcumin in plasma vs. dose

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Collaborators

  • Bupa Chile
  • Kwong Wah Hospital

Registry information

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 14, 2005
Registry last updated
Apr 30, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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