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

Not Applicable

Completed

• Conditions: Mild Cognitive Impairment

• Registration Number: NCT03928613
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2019-04-17
• Study First Submitted: 2019-04-24
• Study First Submitted QC: 2019-04-25
• Study First Posted: 2019-04-26
• Primary Completion: 2019-12-31
• Study Completion: 2020-02-28
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-16
• Last Update Posted: 2020-03-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 43

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in CERAD-TS1 score	baseline and 6 weeks	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

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital,; 🇰🇷 Seongnam-si, Gyeonggi, Korea, Republic of