Centre For Clinical Research And Biostatistics (CCRB)

Back History

1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00527

2 Trial Registration Date

2016-09-07

iRegistration Status

Prospective

3 Secondary IDs

2016.344

4 Source(s) of Funding

NA

5 Primary Sponsor

The Chinese University of Hong Kong

6 Secondary Sponsor

NA

Function

Not Applicable

Please specify

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

i Name

Ms. Maria Lai

ii Address

Room 501-2, JC School of Public Health and Primary Care,
The Chinese University of Hong Kong,
Prince of Wales Hospital,
Shatin, N.T.
Hong Kong

iii Phone

2252 8865

iv Email

marialai@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong, China SAR

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

i Name

Benny Zee

ii Address

Room 501-2, JC School of Public Health and Primary Care,
The Chinese University of Hong Kong,
Prince of Wales Hospital,
Shatin, N.T.
Hong Kong

iii Phone

2252-8865

iv Email

bzee@cuhk.edu.hk

v Affiliation

CUHK

vi Country

Hong Kong, China SAR

9 Official Scientific Title of the Study

A Pilot study for the development of an automatic retinal image analysis (ARIA) method for screening individuals with Alzheimer’s Disease (AD) and Dementia

10 Public Title

A Pilot study for the development of an automatic retinal image analysis (ARIA) method for screening individuals with Alzheimer’s Disease (AD) and Dementia

i Public Title in Chinese 研究名稱

以自動視網膜圖像分析系統(ARIAS)的方法篩查認知障礙症的初步研究

11 Short Title (Optional)

12 Countries of Recruitment

Hong Kong, China

13Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2016-07-18

iii Full Name of IRB/IEC

Joint CUHK-NTEC Clinical Research Ethics Committee

Please specify

iv IRB/IEC approval reference number

2016.344

14 Medical Condition Being Studied

Alzheimer’s Disease (AD) and Dementia

15Intervention

i Types of intervention

Other

Please specify

NA

ii Description/ name of Intervention/article

NA

iii Dosage form of the intervention

NA

iv Dosage of the intervention

NA

v Duration of the intervention

NA

vi Frequency of the intervention

NA

16Comparative Treatments

i Description/ name of comparative treatments

NA

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17Key Inclusion and Exclusion Criteria

i Inclusion Criteria

one with clinical diagnosis of definite or “Probable Alzheimer’s disease” as defined by National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer’s Disease and Related Disorders Association (NINCDS-ADRDA)

Healthy subjects selected in the community with a similar gender and age range

ii Exclusion Criteria

Poor retinal images quality that cannot be used in the analysis

Subjects with other eye diseases which are not suitable for retinal imaging, such as severe cataract, glaucoma, atretopsia, corneal plague

Written consents are not granted by subjects' parents or subject

iii Age Minimum

18

iv Age Maximum

99

v Gender

Both Male and Female

18 Study Type

Observational

19Study Design

i Randomization

Not Applicable

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Not Applicable

If Single-blind, who will be masked?

iv Group Assignment

Not Applicable

v Study Phase

Other

Please specify

NA

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-09-16

21 Target Sample Size

200

22 Recruitment Status

Recruiting

23Primary Outcome

iThe Name of the outcome

Association between AD and retinal characteristics

iiThe metric or method of measurement used

Retinal images

iiiThe timepoint(s) of primary interest

Once

24Secondary Outcome

iThe Name of the outcome

NA

iiThe metric or method of measurement used

NA

iiiThe timepoint(s) of primary interest

NA

25Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26Last Update Date

2017-02-02

27 Primary Registry and Trial Identifying Number

ChiCTR-SPC-16009190

28 Date of Registration in Primary Registry

2016-09-07

Back History

Trial Detail