NCT03577717

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

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

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

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
8 days until next milestone

Study Start

First participant enrolled

July 13, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2019

Completed
26 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 11, 2019

Completed
Last Updated

February 17, 2020

Status Verified

February 1, 2020

Enrollment Period

7 months

First QC Date

June 4, 2018

Last Update Submit

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

EXPERIMENTAL

participants will be trained by the "Cookies for the brainy day", including memory, attention, calculation, executive functions, and language training.

Other: computerized cognitive training

occupational therapy

ACTIVE COMPARATOR

participants will receive craft activities of occupational therapy, such as weaving, origami etc.

Other: occupational therapy

Interventions

participants will be trained 30 minutes/day, 3 days/week for 4 consecutive weeks.

computerized cognitive training

participants will receive craft activities of occupational therapy for 30 minutes/day, 3 days/week for 4 consecutive weeks.

occupational therapy

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

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

Location

Related Publications (56)

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MeSH Terms

Conditions

Cognitive Dysfunction

Interventions

Occupational Therapy

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeutics

Study Officials

  • Wan-ying Chang, MS

    Division of Occupational Therapy,Taipei Hospital, Ministry of Health and Welfare

    PRINCIPAL INVESTIGATOR

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.

Locations