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

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ClinicalTrials.gov Identifier: NCT00164749
Recruitment Status : Completed
First Posted : September 14, 2005
Last Update Posted : April 30, 2008
Sponsor:
Collaborators:
BUPA Foundation
Kwong Wah Hospital
Information provided by:
Chinese University of Hong Kong

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

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: Placebo and ginkgo extract Drug: Curcumin and ginkgo extract Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease
Study Start Date : October 2004
Actual Primary Completion Date : July 2006
Actual Study Completion Date : July 2006

Resource links provided by the National Library of Medicine


Arms and Interventions
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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.
Experimental: 4 gram
4 g/day curcumin
 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.


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00164749


Locations
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Hong Kong
The Chinese University of Hong Kong
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
BUPA Foundation
Kwong Wah Hospital
Investigators
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Principal Investigator: Larry Baum, PhD Chinese University of Hong Kong
More Information
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Publications of Results:

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ClinicalTrials.gov Identifier: NCT00164749    
Other Study ID Numbers: CRE-2003.090-T
First Posted: September 14, 2005    Key Record Dates
Last Update Posted: April 30, 2008
Last Verified: April 2008
Keywords provided by Chinese University of Hong Kong:
dementia
cognition
memory
neurodegenerative disease
brain
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
 Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action