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Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application

Primary Purpose

Mild Cognitive Impairment, Alzheimer's Disease

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Categorical Language Fluency Smartphone Application
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Mild cognitive impairment, Cognitive rehabilitation, Cognitive therapy, Alzheimer's disease, Memory enhancement, Categorical language fluency

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Aged above 55

  • Confirmed literacy

    • Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.
    • Diagnosed to possible or probable Alzheimer's dementia by NINCDS-ADRDA and Clinical Dementia Rating(CDR) of 1 or below.

Exclusion Criteria:

  • Evidence of delirium, confusion
  • Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
  • Evidence of severe cerebrovascular pathology
  • History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity
  • History of substance abuse or dependence such as alcohol
  • Presence of depressive symptoms that could influence cognitive function
  • Presence of medical comorbidities that could result in cognitive decline

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Categorical Language Fluency Smartphone Application

    Arm Description

    Smartphone game application specifically aimed at training categorical language fluency

    Outcomes

    Primary Outcome Measures

    Application usage log
    Log to assess compliance of participant(by describing frequency and duration of training by using application)

    Secondary Outcome Measures

    Subjective Memory Complaint Questionnaire
    to evaluate efficacy of application
    Geriatric Depression Scale
    to evaluate efficacy of application
    Korean version of MMSE for dementia screening
    to evaluate efficacy of application

    Full Information

    First Posted
    July 20, 2016
    Last Updated
    March 23, 2020
    Sponsor
    Seoul National University Bundang Hospital
    Collaborators
    Seoul National University, Ministry of Science, ICT and Future Planning
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02848404
    Brief Title
    Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application
    Official Title
    A Study of Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application in Mild Cognitive Impairment and Mild Alzheimer's Dementia (Baseline Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 2016 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    February 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Seoul National University Bundang Hospital
    Collaborators
    Seoul National University, Ministry of Science, ICT and Future Planning

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The purpose of this study is to examine therapeutic efficacy of categorical language fluency smartphone game application in mild cognitive impairment and mild Alzheimer's dementia.
    Detailed Description
    The Categorical Language Fluency Smartphone Game Application was developed based on the semantic distance training, which was effective in improving categorical language fluency of mild cognitive impairment and mild Alzheimer's dementia. 10 patients with mild cognitive impairment and another 10 patients with mild Alzheimer's dementia were recruited to examine therapeutic efficacy of the application.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Mild Cognitive Impairment, Alzheimer's Disease
    Keywords
    Mild cognitive impairment, Cognitive rehabilitation, Cognitive therapy, Alzheimer's disease, Memory enhancement, Categorical language fluency

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Categorical Language Fluency Smartphone Application
    Arm Type
    Experimental
    Arm Description
    Smartphone game application specifically aimed at training categorical language fluency
    Intervention Type
    Device
    Intervention Name(s)
    Categorical Language Fluency Smartphone Application
    Intervention Description
    4 weeks' training
    Primary Outcome Measure Information:
    Title
    Application usage log
    Description
    Log to assess compliance of participant(by describing frequency and duration of training by using application)
    Time Frame
    4-weeks treatment
    Secondary Outcome Measure Information:
    Title
    Subjective Memory Complaint Questionnaire
    Description
    to evaluate efficacy of application
    Time Frame
    after 4-weeks treatment
    Title
    Geriatric Depression Scale
    Description
    to evaluate efficacy of application
    Time Frame
    after 4-weeks treatment
    Title
    Korean version of MMSE for dementia screening
    Description
    to evaluate efficacy of application
    Time Frame
    after 4-weeks treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Aged above 55 Confirmed literacy Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5. Diagnosed to possible or probable Alzheimer's dementia by NINCDS-ADRDA and Clinical Dementia Rating(CDR) of 1 or below. Exclusion Criteria: Evidence of delirium, confusion Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus Evidence of severe cerebrovascular pathology History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity History of substance abuse or dependence such as alcohol Presence of depressive symptoms that could influence cognitive function Presence of medical comorbidities that could result in cognitive decline
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ki Woong Kim, M.D., Ph.D.
    Organizational Affiliation
    Seoul National University Bundang Hospital, Seong-nam, Korea
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

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    Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application

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