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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 1
Locations
Hong Kong
Study Type
Interventional
Intervention
Placebo and ginkgo extract
Curcumin and ginkgo extract
Curcumin and ginkgo extract
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring dementia, cognition, memory, neurodegenerative disease, brain

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Chinese University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Experimental

Arm Label

Placebo

1 gram

4 gram

Arm Description

Color-matched placebo

1 g/day curcumin

4 g/day curcumin

Outcomes

Primary Outcome Measures

Change in isoprostane level in plasma
Change in A-beta level in serum

Secondary Outcome Measures

Change in cognitive function (MMSE score)
Change in cholesterol and triglycerides in serum
Change in metals in serum
Level of curcumin in plasma vs. dose

Full Information

First Posted
September 9, 2005
Last Updated
April 25, 2008
Sponsor
Chinese University of Hong Kong
Collaborators
BUPA Foundation, Kwong Wah Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00164749
Brief Title
A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease
Official Title
A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Completed
Study Start Date
October 2004 (undefined)
Primary Completion Date
July 2006 (Actual)
Study Completion Date
July 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Chinese University of Hong Kong
Collaborators
BUPA Foundation, Kwong Wah Hospital

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
dementia, cognition, memory, neurodegenerative disease, brain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Color-matched placebo
Arm Title
1 gram
Arm Type
Experimental
Arm Description
1 g/day curcumin
Arm Title
4 gram
Arm Type
Experimental
Arm Description
4 g/day curcumin
Intervention Type
Drug
Intervention Name(s)
Placebo and ginkgo extract
Intervention Description
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
Intervention Name(s)
Curcumin and ginkgo extract
Intervention Description
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
Intervention Name(s)
Curcumin and ginkgo extract
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in isoprostane level in plasma
Time Frame
1 and 6 months
Title
Change in A-beta level in serum
Time Frame
1 and 6 months
Secondary Outcome Measure Information:
Title
Change in cognitive function (MMSE score)
Time Frame
6 months
Title
Change in cholesterol and triglycerides in serum
Time Frame
1 and 6 months
Title
Change in metals in serum
Time Frame
1 month
Title
Level of curcumin in plasma vs. dose
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Baum, PhD
Organizational Affiliation
Chinese University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Chinese University of Hong Kong
City
Shatin
Country
Hong Kong

12. IPD Sharing Statement

Citations:
PubMed Identifier
18204357
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, 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.
Results Reference
result
PubMed Identifier
17951067
Citation
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.
Results Reference
result

Learn more about this trial

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

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