A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease - Full Text View

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 I Phase II

Genetics Home Reference related topics:

Alzheimer disease

MedlinePlus related topics:

Alzheimer's Disease Dementia

Drug Information available for:

Curcumin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

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

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: Placebo Comparator 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.
1 gram: Experimental 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.
4 gram: Experimental 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

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 of Results:

Baum L, Lam CW, Cheung SK, Kwok T, Lui V, Tsoh J, Lam L, Leung V, Hui E, Ng C, Woo J, Chiu HF, Goggins WB, Zee BC, Cheng KF, Fong CY, Wong A, Mok H, Chow MS, Ho PC, Ip SP, Ho CS, Yu XW, Lai CY, Chan MH, Szeto S, Chan IH, Mok V. Six-month randomized, placebo-controlled, double-blind, pilot clinical trial of curcumin in patients with Alzheimer disease. J Clin Psychopharmacol. 2008 Feb;28(1):110-3. No abstract available.

Baum L, Cheung SK, Mok VC, Lam LC, Leung VP, Hui E, Ng CC, Chow M, Ho PC, Lam S, Woo J, Chiu HF, Goggins W, Zee B, Wong A, Mok H, Cheng WK, Fong C, Lee JS, Chan MH, Szeto SS, Lui VW, Tsoh J, Kwok TC, Chan IH, Lam CW. Curcumin effects on blood lipid profile in a 6-month human study. Pharmacol Res. 2007 Dec;56(6):509-14. Epub 2007 Sep 18.

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

Keywords provided by Chinese University of Hong Kong:

dementia

cognition

memory

neurodegenerative disease

brain

Study placed in the following topic categories:

Curcumin

Delirium, Dementia, Amnestic, Cognitive Disorders

Mental Disorders

Alzheimer Disease

Central Nervous System Diseases

Brain Diseases

Neurodegenerative Diseases

Dementia

Cognition Disorders

Delirium

Additional relevant MeSH terms:

Anti-Inflammatory Agents

Molecular Mechanisms of Pharmacological Action

Antineoplastic Agents

Nervous System Diseases

Physiological Effects of Drugs

Enzyme Inhibitors

Pharmacologic Actions

Analgesics, Non-Narcotic

Sensory System Agents

Therapeutic Uses

Anti-Inflammatory Agents, Non-Steroidal

Analgesics

Peripheral Nervous System Agents

Tauopathies

Antirheumatic Agents

Central Nervous System Agents

ClinicalTrials.gov processed this record on October 23, 2008

Sponsors and Collaborators:	Chinese University of Hong Kong BUPA Foundation Kwong Wah Hospital
Information provided by:	Chinese University of Hong Kong
ClinicalTrials.gov Identifier:	NCT00164749