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

NCT ID: NCT00164749

Last Updated: 2008-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-10-31

Study Completion Date

2006-07-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Alzheimer's Disease

Keywords

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dementia cognition memory neurodegenerative disease brain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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Placebo

Color-matched placebo

Group Type PLACEBO_COMPARATOR

Placebo and ginkgo extract

Intervention Type DRUG

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

1 g/day curcumin

Group Type EXPERIMENTAL

Curcumin and ginkgo extract

Intervention Type DRUG

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

4 g/day curcumin

Group Type EXPERIMENTAL

Curcumin and ginkgo extract

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BUPA Foundation

OTHER

Sponsor Role collaborator

Kwong Wah Hospital

OTHER

Sponsor Role collaborator

Chinese University of Hong Kong

OTHER

Sponsor Role lead

Principal Investigators

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Larry Baum, PhD

Role: PRINCIPAL_INVESTIGATOR

Chinese University of Hong Kong

Locations

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The Chinese University of Hong Kong

Shatin, , Hong Kong

Site Status

Countries

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Hong Kong

References

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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. doi: 10.1097/jcp.0b013e318160862c. No abstract available.

Reference Type RESULT
PMID: 18204357 (View on PubMed)

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. doi: 10.1016/j.phrs.2007.09.013. Epub 2007 Sep 18.

Reference Type RESULT
PMID: 17951067 (View on PubMed)

Other Identifiers

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CRE-2003.090-T

Identifier Type: -

Identifier Source: org_study_id