Study Stopped
This study was stopped due to time and budgetary constraints.
Efficacy of Computerized Cognitive Training in the Elderly With Mild Cognitive Impairment
1 other identifier
interventional
7
1 country
1
Brief Summary
Mild cognitive impairment (MCI) is the prodrome of the cognitive function declining before Alzheimer's disease or other dementia showed up, the impairments of language, visuospatial relationship, attention, and memory included and instrumental activities of daily living (IADL) influenced. MCI is considered as a transitional stage between normal aging and mild dementia, and the patients with MCI has differently fluctuated cognitive functions in a period of time, such as from normal cognition to MCI or developing to dementia. The annual conversion rate (ACR) of older adults with normal cognition developed to MCI is 30%, and 5% in clinical setting, and community, respectively. Not all of patients with MCI develop to Alzheimer's disease, the reversion of patients with MCI to normal cognition exists. However, MCI is a significant risk factor. The ACR of older adults with normal cognition or MCI developed to dementia is 1-2%, and 5-15%, respectively; moreover, about half of patients with MCI developed to dementia in 5 years. Cognitive training (CT) improves cognitive functions with repetitive practicing standardized cognitive tasks of specific cognitive functions, such as memory, attention, or problem solving. CT has widely defined including strategy training, in which contained cognitive exercise, strategy indicating and practicing to reducing cognitive impairments and improving performances. CT is more effective for MCI. Recently, computer-based CT (CCT) with many advantages gradually replaced the traditional paper-pencil form. Brief systematic review showed that the computer-based intervention had positive effects on behavioral symptoms, such as depression and anxiety, in patients with MCI and/or dementia. Previous studies demonstrated that computer-based intervention exhibited moderate treatment effects on overall cognitive functions in patients with MCI, and also had positive effects on learning, short-term memory, and behavioral symptoms. Older people with cognitive impairments is expected to increase by global aging. It is important for improving or maintaining cognitive functions of older adults with MCI. The efficacy of the CCT on cognitive functions, neuropsychiatric symptoms, daily functions, and brain activated imaging of the magnetoencephalography (MEG) of in older adults with MCI is worth to explore for busy clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2018
CompletedFirst Posted
Study publicly available on registry
July 5, 2018
CompletedStudy Start
First participant enrolled
July 13, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 13, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 11, 2019
CompletedFebruary 17, 2020
February 1, 2020
7 months
June 4, 2018
February 12, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
Change scores of Quick Mild Cognitive Impairment screen
The Quick Mild Cognitive Impairment (Qmci) screen , a performance test, contains 6 subtests: Orientation, Registration, Clock Drawing, Delayed Recall, Verbal Fluency, and Logical Memory. The Qmci can be administered and scored in less than 5 min. The Qmci was validated with sound reliability and validity. The Qmci screen scores ranged from 0 to 100, with a higher score indicating greater cognitive function.
Baseline, 1 month, 2 months
Change scores of Montreal Cognitive Assessment
The Montreal Cognitive Assessment (MoCA), a performance test, is a standardized and validated tool designed to measure cognitive functions in visuospatial/executive, naming, memory, attention, language, abstraction, delayed recall, and orientation. The MoCA adds 1 score for those whose educational level ≤ 12 and scores ranged from 0 to 30, with a higher score indicating greater cognitive function.
Baseline, 1 month, 2 months
Secondary Outcomes (9)
Change scores of Contextual Memory Test
Baseline, 1 month, 2 months
Change scores of Color Trail Test
Baseline, 1 month, 2 months
Change scores of Digits Span Tasks-forward and backward
Baseline, 1 month, 2 months
Change scores of Cancellation Test
Baseline, 1 month, 2 months
Change scores of Pattern Comparison
Baseline, 1 month, 2 months
- +4 more secondary outcomes
Other Outcomes (1)
Imaging change of the MEG
Baseline, 1 month, 2 months
Study Arms (2)
computerized cognitive training
EXPERIMENTALparticipants will be trained by the "Cookies for the brainy day", including memory, attention, calculation, executive functions, and language training.
occupational therapy
ACTIVE COMPARATORparticipants will receive craft activities of occupational therapy, such as weaving, origami etc.
Interventions
participants will be trained 30 minutes/day, 3 days/week for 4 consecutive weeks.
participants will receive craft activities of occupational therapy for 30 minutes/day, 3 days/week for 4 consecutive weeks.
Eligibility Criteria
You may qualify if:
- (1) were aged ≥65 years
- (2) amnestic type MCI was made using National Institute on Aging-Alzheimer's Association workgroups diagnostic guidelines for Alzheimer's disease with the clinical dementia rating scale (CDR) global scores of 0.5
- (3) could follow command, understand the content of the assessments, and cooperate with treatment interventions through verbal communication
You may not qualify if:
- (1) had the score of Geriatric Depression Scale-Short Form (GDS-SF) \> 7, indicating depression status
- (2) had the score of Barthel Index (BI)≠100, indicating dependent basic daily living of activities
- (3) were diagnosed with other MCI subtypes, including frontotemporal dementia or Lewy Body those present typically different MCI syndromes
- (4) had other neuropsychotic diseases
- (5) could not administrate with MEG
- (6) could not participate due to severe health problem
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Taipei Hospital, Ministry of Health and Welfare
New Taipei City, 24213, Taiwan
Related Publications (56)
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MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Wan-ying Chang, MS
Division of Occupational Therapy,Taipei Hospital, Ministry of Health and Welfare
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- occupational therapist
Study Record Dates
First Submitted
June 4, 2018
First Posted
July 5, 2018
Study Start
July 13, 2018
Primary Completion
February 13, 2019
Study Completion
March 11, 2019
Last Updated
February 17, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share
Data are available from the Institutional Review Board of the Taipei Hospital, Ministry of Health and Welfare for researchers who meet the criteria for access to confidential data.