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

April 25, 2008 updated by: Chinese University of Hong Kong
The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Shatin, Hong Kong
        • The Chinese University of Hong Kong

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in cognitive function (MMSE score)
Time Frame: 6 months
6 months
Change in cholesterol and triglycerides in serum
Time Frame: 1 and 6 months
1 and 6 months
Change in metals in serum
Time Frame: 1 month
1 month
Level of curcumin in plasma vs. dose
Time Frame: 1 month
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chinese University of Hong Kong

Collaborators

Kwong Wah Hospital
BUPA Foundation

Investigators

  • Principal Investigator: Larry Baum, PhD, Chinese University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 1, 2006

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

April 30, 2008

Last Update Submitted That Met QC Criteria

April 25, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRE-2003.090-T

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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