Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00016

2 Trial Registration Date

2005-09-05

i Registration Status

Retrospective

3 Secondary IDs

4 Source(s) of Funding

Chinese University of Hong Kong Institute of Chinese Medicine; Chinese University of Hong Kong; and BUPA Foundation

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

Kwong Wah Hospital

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Fion Yip

ii Address

iii Phone

Tel [852] 26323593 or Email fionyip@cuhk.edu.hk

iv Email

Tel or email

v Affiliation

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Larry Baum

ii Address

iii Phone

Tel [852] 26323146 or Email lwbaum@cuhk.edu.hk

iv Email

Tel or email

v Affiliation

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Curcumin for AD

12 Countries of Recruitment

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2003-05-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Nervous System Diseases

15 Intervention

i Types of intervention

Drug

Please specify

ii Description/ name of Intervention/article

Curcumin and ginkgo extract

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 months

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Placebo

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Inclusion: Possible or probable AD. Exclusion: Anticoagulant or antiplatelet treatment or bleeding risk factors; currently smoking; or other severe illness.

ii Exclusion Criteria

iii Age Minimum

iv Age Maximum

v Gender

18 Study Type

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2004-10-07

21 Target Sample Size

30

22 Recruitment Status

Recruiting

23 Primary Outcome

Setting up formulation, patient recruitment, and assay procedures at 0, 1, and 6 months, in preparation for a later clinical trial testing the effectiveness of curcumin and ginkgo in slowing AD progression.

24 Secondary Outcome

Change in biochemical measures of AD: Plasma isoprostane and A-beta levels at 1 and 6 months. Change in cognitive measures of AD: MMSE at 6 months. Change in others: cholesterol, lipid, C reactive protein, and metal levels in serum at 1 and 6 months. Curcumin and metabolites at 1 month.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2011-03-02

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

None

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Trial History Detail on 2005-09-05