Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00016

2 Trial Registration Date

2005-09-05

i Registration Status

Retrospective

3 Secondary IDs

none

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

Department of Medicine and Therapeutics, The Chinese University of Hong Kong, Shatin, Hong Kong

iii Phone

Tel or Tel [852] 26323593

iv Email

email or Email fionyip@cuhk.edu.hk

v Affiliation

Department of Medicine and Therapeutics, The Chinese University of Hong Kong

vi Country

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

i Name

Larry Baum

ii Address

School of Pharmacy, The Chinese University of Hong Kong, Shatin, Hong Kong

iii Phone

Tel or Tel [852] 26323146

iv Email

email or Email lwbaum@cuhk.edu.hk

v Affiliation

School of Pharmacy, The Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

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

10 Public Title

Six-month randomized, placebo-controlled, double-blind, pilot clinical trial of curcumin in patients with Alzheimer disease

i Public Title in Chinese 研究名稱

11 Short Title (Optional)

Curcumin for AD

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2003-04-23

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.

ii Exclusion Criteria

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

iii Age Minimum

50

iv Age Maximum

none

v Gender

Both Male and Female

18 Study Type

Interventional

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

Complete

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

ChiCTR-TRC-09000626

28 Date of Registration in Primary Registry

2010-05-04

Back History

Trial Detail