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Completed

NCT Number: NCT03928613

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

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

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Bundang Hospital,

Seongnam-si, Gyeonggi-do, 13620, South Korea

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

tablet based Cognitive Training based on location information

Behavioral

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 outcomes

  1. Change in CERAD-TS1 score

    Time frame: 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 outcomes

  1. Change in MMSE score

    Time frame: baseline and 6 weeks

    Mini-Mental State Examination (MMSE), ranged 0-30, the higher score represents the better cognitive function

  2. Change in SMCQ score

    Time frame: 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

  3. Change in GDS score

    Time frame: baseline and 6 weeks

    Geriatric depression scale (GDS), ranged 0-30, the higher score represents the more severe depressive symptoms

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Institute of Information & Communications Technology Planning & Evaluation, Korea

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Apr 26, 2019
Registry last updated
Mar 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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