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Trial History Detail on 2014-08-15

CUHK_CCT00428

2014-07-29

Prospective

2014.098-T

Research Grant Council of Hong Kong (General Research Fund)

Department of Psychiatry, The Chinese University of Hong Kong

N/A

Ms Alicia KW Chan 陳嘉媛

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

852-26076046

aliciachan@cuhk.edu.hk

Department of Psychiatry, The Chinese University of Hong Kong

Linda CW Lam 林翠華

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

852-26076027

cwlam@cuhk.edu.hk

Department of Psychiatry, the Chinese University of Hong Kong

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)?

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)?

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

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

Hong Kong SAR, China

Yes

2014-04-22

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

Device

transcranial direct current stimulation and computer based working memory training

4 weeks intervention

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

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

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.

60

90

Both Male and Female

Interventional

Randomized

Active

Double-blind

Parallel

2014-11-01

192

Not Yet Recruiting

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).

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.

Yes

2015-09-08

ChiCTR-TRC-14005036 

2014-07-31


No

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