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

Alzheimer's Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00164749
• Other study ID #: CRE-2003.090-T
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 9, 2005
• Last updated: April 25, 2008
• Start date: October 2004
• Est. completion date: July 2006

Study information

• Verified date: April 2008
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Department of Health
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
Hong Kong	The Chinese University of Hong Kong	Shatin

Sponsors (3)

Lead Sponsor	Collaborator
Chinese University of Hong Kong	BUPA Foundation, Kwong Wah Hospital

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

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 profil — View Citation

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, place — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in isoprostane level in plasma		1 and 6 months	No
Primary	Change in A-beta level in serum		1 and 6 months	No
Secondary	Change in cognitive function (MMSE score)		6 months	No
Secondary	Change in cholesterol and triglycerides in serum		1 and 6 months	No
Secondary	Change in metals in serum		1 month	No
Secondary	Level of curcumin in plasma vs. dose		1 month	No