Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment
Primary Purpose
Mild Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
tablet based Cognitive Training based on location information
Sponsored by

About this trial
This is an interventional treatment trial for Mild Cognitive Impairment focused on measuring Cognitive training, Cognitive intervention, Cognitive rehabilitation
Eligibility Criteria
Inclusion Criteria:
- Aged above 60
- Confirmed literacy o Diagnosed with mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.
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
- Presence of depressive symptoms that could influence cognitive function
- Presence of medical comorbidities that could result in any difficulties in study participation
Sites / Locations
- Seoul National University Bundang Hospital,
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Mild Cognitive Impairment
Arm Description
Clinical dementia rating 0 or 0.5 Diagnosed by physicians as mild cognitive impairment according to the criteria of International Working Group on Mild Cognitive Impairment
Outcomes
Primary Outcome Measures
Change in CERAD-TS1 score
Total Score of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Assessment Battery (CERAD-TS1) . CERAD-TS1 is generated by simply summing the scores of six tests including the 1) Verbal fluency (range 0-24), 2) Boston naming test (0-15), 3) Word List Memory (0-30), 4) Word List Recall (0-10), 5) Word list recognition (0-10), 6) Constructional Praxis (0-11). The range of CERAD-TS1 score is 0 to 100 points), and the higher score represents the better cognitive function.
Secondary Outcome Measures
Change in MMSE score
Mini-Mental State Examination (MMSE), ranged 0-30, the higher score represents the better cognitive function
Change in SMCQ score
Subjective Memory Complaint Questionnaire (SMCQ), ranged 0-14, the higher score represents the more difficulties in memory function for everyday life
Change in GDS score
Geriatric depression scale (GDS), ranged 0-30, the higher score represents the more severe depressive symptoms
Full Information
NCT ID
NCT03928613
First Posted
April 24, 2019
Last Updated
March 16, 2020
Sponsor
Seoul National University Bundang Hospital
Collaborators
Institute of Information & Communications Technology Planning & Evaluation, Korea
1. Study Identification
Unique Protocol Identification Number
NCT03928613
Brief Title
Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment
Official Title
Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
April 17, 2019 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
February 28, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Institute of Information & Communications Technology Planning & Evaluation, Korea
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 cognitive Training based on location information and activity in people with mild cognitive impairment
Detailed Description
A single arm, open-label study.
Cognitive Training based on location information and activity is consists of both cognitive training and exercise(walking) using objects in the participant's home. The researchers visit the participant's home and find objects that were mainly used in the real life and easy to access (table, computer, television, etc.) and attach the recognition Bluetooth Low Energy(BLE) Tag (sticker integrated). The stickers printed on the tags consist of word categories (eg animals) belonging to a particular category, so as to assist strategic recall in the stepped recall task. The participants follow the instruction from the tablet-based program to perform the task. During performing the cognitive training program, the participants are guided to walk between the tagged objects in their home.
The participants are aged over 60 years old and diagnosed with mild cognitive impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Cognitive Impairment
Keywords
Cognitive training, Cognitive intervention, Cognitive rehabilitation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
43 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mild Cognitive Impairment
Arm Type
Experimental
Arm Description
Clinical dementia rating 0 or 0.5
Diagnosed by physicians as mild cognitive impairment according to the criteria of International Working Group on Mild Cognitive Impairment
Intervention Type
Behavioral
Intervention Name(s)
tablet based Cognitive Training based on location information
Intervention Description
Participants perform Tablet based Cognitive training using interactive voice services and tags three times (minimum 30 minutes per time) a week for 6 weeks
Primary Outcome Measure Information:
Title
Change in CERAD-TS1 score
Description
Total Score of the Consortium to Establish a Registry for Alzheimer's Disease (CERAD) Neuropsychological Assessment Battery (CERAD-TS1) . CERAD-TS1 is generated by simply summing the scores of six tests including the 1) Verbal fluency (range 0-24), 2) Boston naming test (0-15), 3) Word List Memory (0-30), 4) Word List Recall (0-10), 5) Word list recognition (0-10), 6) Constructional Praxis (0-11). The range of CERAD-TS1 score is 0 to 100 points), and the higher score represents the better cognitive function.
Time Frame
baseline and 6 weeks
Secondary Outcome Measure Information:
Title
Change in MMSE score
Description
Mini-Mental State Examination (MMSE), ranged 0-30, the higher score represents the better cognitive function
Time Frame
baseline and 6 weeks
Title
Change in SMCQ score
Description
Subjective Memory Complaint Questionnaire (SMCQ), ranged 0-14, the higher score represents the more difficulties in memory function for everyday life
Time Frame
baseline and 6 weeks
Title
Change in GDS score
Description
Geriatric depression scale (GDS), ranged 0-30, the higher score represents the more severe depressive symptoms
Time Frame
baseline and 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged above 60
Confirmed literacy o Diagnosed with mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.
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
Presence of depressive symptoms that could influence cognitive function
Presence of medical comorbidities that could result in any difficulties in study participation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ji Won Han, M.D., Ph.D.
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital,
City
Seongnam-si
State/Province
Gyeonggi
ZIP/Postal Code
13620
Country
Korea, Republic of
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment
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