Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment

Conditions
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Mild Cognitive Impairment

Intervention / Treatment
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* Behavioral: tablet based Cognitive Training based on location information


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild Cognitive Impairment<br>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 | Behavioral: tablet based Cognitive Training based on location information<br>* Participants perform Tablet based Cognitive training using interactive voice services and tags three times (minimum 30 minutes per time) a week for 6 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | baseline and 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MMSE score | Mini-Mental State Examination (MMSE), ranged 0-30, the higher score represents the better cognitive function | baseline and 6 weeks | 
| 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 | baseline and 6 weeks | 
| Change in GDS score | Geriatric depression scale (GDS), ranged 0-30, the higher score represents the more severe depressive symptoms | baseline and 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive training, Cognitive intervention, Cognitive rehabilitation