Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00428

2 Trial Registration Date

2014-07-29

i Registration Status

Prospective

3 Secondary IDs

2014.098-T

4 Source(s) of Funding

Research Grant Council of Hong Kong (General Research Fund)

5 Primary Sponsor

Department of Psychiatry, The Chinese University of Hong Kong

6 Secondary Sponsor

N/A

Function

Please specify

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

i Name

Ms Alicia KW Chan 陳嘉媛

ii Address

Department of Psychiatry, G/F Multi-Centre, Tai Po Hospital, Tai Po. NT, Hong Kong

iii Phone

852-26076046

iv Email

aliciachan@cuhk.edu.hk

v Affiliation

Department of Psychiatry, The Chinese University of Hong Kong

vi Country

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

i Name

Linda CW Lam 林翠華

ii Address

Department of Psychiatry, G/F Multi-Centre, Tai Po Hospital, Tai Po. NT, Hong Kong

iii Phone

852-26076027

iv Email

cwlam@cuhk.edu.hk

v Affiliation

Department of Psychiatry, the Chinese University of Hong Kong

vi Country

9 Official Scientific Title of the Study

Would transcranial direct current stimulation (tDCS) enhance the effects of working memory training in older adults with mild neurocognitive disorder due to Alzheimer's disease (AD)?

10 Public Title

Would transcranial direct current stimulation (tDCS) enhance the effects of working memory training in older adults with mild neurocognitive disorder due to Alzheimer's disease (AD)?

i Public Title in Chinese 研究名稱

工作記憶訓練與腦部直流電剌激對輕度阿氏認知障礙症之治療成效研究

11 Short Title (Optional)

Transcranial direct current stimulation and working memory training for mild neurocognitive disorder

12 Countries of Recruitment

Hong Kong SAR, China

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-04-22

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Mild Neurocognitive Disorder due to Alzheimer's Disease (AD)

15 Intervention

i Types of intervention

Device

Please specify

ii Description/ name of Intervention/article

transcranial direct current stimulation and computer based working memory training

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

4 weeks intervention

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

4 week intervention of either tDCS-working memory (DCS-WM), tDCS-control cognitive training(DCS-CC), and sham tDCS-working memory (WM-CD) groups

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

1. Subjects from 60 to 90 years old,
2. DSM-5 diagnosis of Mild Neurocognitive Disorder due to Alzhemer's disease.

ii Exclusion Criteria

1. Previous diagnosis of other major neurocognitive
disorders,
2. Past history of bipolar affective disorder or psychosis,
3. Physically frail affecting attendance to training sessions,
4. Already attending regular cognitive training,
5. Taking a psychotropic or other medication known to affect cognition (e.g. benzodiazepines, anti-dementia medication, etc.),
6. History of major neurological deficit including history of stroke, transient ischemic attack or traumatic brain injury, and
7. Significant communicative impairments.

iii Age Minimum

60

iv Age Maximum

90

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Active

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

2014-11-01

21 Target Sample Size

192

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Assessments will be conducted at the baseline, 4th week, 8th week and 12th week.
1. Working memory test – the n-back task performance at baseline, 4th, 8th and 12th
weeks would be recorded as a direct measure of improvement in task performance.
2. Global Cognitive function would be measured by the Chinese version of the Alzheimer’s disease Assessment Scale – Cognitive Subscale (ADAS-Cog). It is a standard global cognitive assessment for clinical intervention of AD. The scale score ranges from 0 to 70, with increasing scores indicating higher severity of global cognitive impairment (31).

24 Secondary Outcome

Assessments will be conducted at the baseline, 4th week, 8th week and 12th week.
1. Memory and Language tests – Logical memory, 10 minutes list learning delay recall, category verbal fluency and trail making tests would also be evaluated to examine the effects of both tDCS and working memory training on other cognitive abilities (32).
2. The Chinese Neuropsychiatric Inventory (NPI)(33) would used to assess changes in neuropsychiatric symptoms across different 12 domains. In the current study, NPI would evaluate potential mood and behavioral change, especially mood and euphoria that may theoretically be affected by tDCS administration.
3. A checklist of potential adverse effects associated with computer based cognitive training and t-DCS administration would be generated from available literature reports. The checklist would be used to monitor tolerability and adverse events throughout intervention.

25 Study Information/Publication

i Study Information/Publication Available?

Yes

ii Link to Study Information/Publication

N/A

26 Last Update Date

2015-09-08

27 Primary Registry and Trial Identifying Number

ChiCTR-TRC-14005036

28 Date of Registration in Primary Registry

2014-07-31

* Legacy Fields

i Recruitment Information Available?

No

ii Link to Recruitment Information

None

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Trial History Detail on 2014-08-15