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

This study has been completed.
Sponsor:
Collaborators:
BUPA Foundation
Kwong Wah Hospital
Information provided by:
Chinese University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00164749
First received: September 9, 2005
Last updated: April 25, 2008
Last verified: April 2008

September 9, 2005
April 25, 2008
October 2004
July 2006   (final data collection date for primary outcome measure)
  • Change in isoprostane level in plasma [ Time Frame: 1 and 6 months ] [ Designated as safety issue: No ]
  • Change in A-beta level in serum [ Time Frame: 1 and 6 months ] [ Designated as safety issue: No ]
  • Change in isoprostane level in plasma at 1 and 6 months
  • Change in A-beta level in serum at 1 and 6 months
Complete list of historical versions of study NCT00164749 on ClinicalTrials.gov Archive Site
  • Change in cognitive function (MMSE score) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change in cholesterol and triglycerides in serum [ Time Frame: 1 and 6 months ] [ Designated as safety issue: No ]
  • Change in metals in serum [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Level of curcumin in plasma vs. dose [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • Change in cognitive function (MMSE score) at 6 months
  • Change in C reactive protein in serum at 1 and 6 months
  • Change in cholesterol and triglycerides in serum at 1 and 6 months
  • Change in metals in serum at 1 and 6 months
  • Level of curcumin in plasma vs. dose at 1 month
Not Provided
Not Provided
 
A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease
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.

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.

Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Alzheimer's Disease
  • 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.
  • 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.
  • Placebo Comparator: Placebo
    Color-matched placebo
    Intervention: Drug: Placebo and ginkgo extract
  • Experimental: 1 gram
    1 g/day curcumin
    Intervention: Drug: Curcumin and ginkgo extract
  • Experimental: 4 gram
    4 g/day curcumin
    Intervention: Drug: Curcumin and ginkgo extract

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
36
July 2006
July 2006   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hong Kong
 
NCT00164749
CRE-2003.090-T
Not Provided
Not Provided
Chinese University of Hong Kong
  • BUPA Foundation
  • Kwong Wah Hospital
Principal Investigator: Larry Baum, PhD Chinese University of Hong Kong
Chinese University of Hong Kong
April 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP