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
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease

Resource links provided by NLM:


Further study details as provided by Chinese University of Hong Kong:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 36
Study Start Date: October 2004
Study Completion Date: July 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00164749

Locations
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
Principal Investigator: Larry Baum, PhD Chinese University of Hong Kong
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00164749     History of Changes
Other Study ID Numbers: CRE-2003.090-T
Study First Received: September 9, 2005
Last Updated: April 25, 2008
Health Authority: Hong Kong: Department of Health

Keywords provided by Chinese University of Hong Kong:
dementia
cognition
memory
neurodegenerative disease
brain

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Curcumin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Antineoplastic Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014