Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00445

2 Trial Registration Date

2015-02-03

i Registration Status

Prospective

3 Secondary IDs

2014.566

4 Source(s) of Funding

Health and Medical 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 Harriet W Y Tang 鄧穎瑜

ii Address

Room 3A, Block E, Staff Quarters, Prince of Wales Hospital, 46 Ngan Shing Street, Shatin

iii Phone

852-28314305

iv Email

harriet@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

Prof. 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

A randomized controlled trial of combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer’s disease

10 Public Title

A randomized controlled trial of combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer’s disease

i Public Title in Chinese 研究名稱

運動訓練與工作記憶訓練對減慢輕度阿氏痴呆症長者認知能力下降之隨機對比研究

11 Short Title (Optional)

A randomized controlled trial of combined physical exercise-working memory training on slowing down cognitive decline in elders with mild clinical Alzheimer’s disease

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?

2014-12-18

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Mild clinical Alzheimer’s disease

15 Intervention

i Types of intervention

Behavior

Please specify

ii Description/ name of Intervention/article

Physical exercise and Working memory training

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

6 weeks intervention

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

6 week intervention of either physical exercise (PE) training, working memory (WM) training, combined PE-WM training, or caregiver education (control)

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 Major Neurocognitive Disorder due to AD (22), which would satisfy the criteria for significant cognitive decline in at least one of six areas of cognition (memory, perceptual-motor, complex attention, language, executive function and social cognition) and functional disturbance, with clinical or biological features indicative of AD;
3. CDR of 1 indicating mild dementia; and
4. Ambulatory with low risk of fall as assessed by the physiotherapist (co-A)

ii Exclusion Criteria

1. Past history of bipolar affective disorder or psychosis;
2 Physical frailty affecting attendance to training sessions;
3. Already attending regular cognitive training;
4. History of major neurological deficit including history of stroke, or traumatic brain injury; and
5. 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

Single-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

2015-02-14

21 Target Sample Size

376

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

Global cognitive function would be measured by the Chinese version of the
Alzheimer’s Disease Assessment Scale – Cognitive Subscale (ADAS-Cog) (25). Itis a standard global cognitive assessment for clinical intervention of AD.CMMSE scores would also be recorded as a measure of global cognition. Assesment and records of adverse events will be conducted at baseline, 6th week and 12th weeks.

24 Secondary Outcome

Clinical Dementia Rating (CDR) is a semi-structured clinical interview for the severity of cognitive impairment rated along six dimensions of cognition and function (memory, orientation, judgment & problem solving, community affairs,home, hobbies and personal care. Scores in each dimension are combined to forma global rating ranging from 0 (not demented), 0.5 (very mild), 1 (mild), 2(moderate) to 3 (severe dementia). (20).

Working memory test – the n-back task performance at baseline, 6th and 12th weeks would be recorded as a direct measure of improvement in task
performance.

Memory and language tests – logical memory, 10 minutes list learning delay recall,
category verbal fluency and trail making tests would be evaluated to examine the effects of both PE and WM training on other cognitive abilities.

The Chinese Neuropsychiatric Inventory (NPI) would be used to assess changes in neuropsychiatric symptoms across 12 different domains. In the current proposal, NPI would evaluate potential mood and behavioral changes.

The Disability Assessment for Dementia (DAD) assesses functional abilities in
both basic and instrumental activities of daily living.

Revised Borg Scale to measure subjective sense of exertion.

Quality of Life –AD. It is a 13 item instrument adopted as a generic measure for the quality of life in patients with Alzheimer’s disease.

Leisure activity participation – in order to measure behavioral change after participation of the study..

Assesment and records of adverse events will be conducted at baseline, 6th week and 12th weeks.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-03-04

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

N/A

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Trial History Detail on 2015-02-03