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

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ClinicalTrials.gov Identifier: NCT03928613
Recruitment Status : Recruiting
First Posted : April 26, 2019
Last Update Posted : April 29, 2019
Sponsor:
Collaborator:
Institute of Information & Communications Technology Planning & Evaluation, Korea
Information provided by (Responsible Party):
Ji Won Han, 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

Condition or disease Intervention/treatment Phase
Mild Cognitive Impairment Behavioral: tablet based Cognitive Training based on location information Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment
Actual Study Start Date : April 17, 2019
Estimated Primary Completion Date : August 31, 2019
Estimated Study Completion Date : February 28, 2020

Arm Intervention/treatment
Experimental: Mild Cognitive Impairment
  • 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
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 Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03928613


Contacts
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Contact: Ji Won Han, M.D., Ph.D. +82-787-7438 jwhanmd@snu.ac.kr
Contact: Woori Moon, M.D. +82-787-6073 m.woori@gmail.com

Locations
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Korea, Republic of
Seoul National University Bundang Hospital, Recruiting
Seongnam-si, Gyeonggi, Korea, Republic of, 13620
Contact: Woori Moon, M.D.    82-031-787-6073    m.woori@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Institute of Information & Communications Technology Planning & Evaluation, Korea
Investigators
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Principal Investigator: Ji Won Han, M.D., Ph.D. Seoul National University Bundang Hospital

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Responsible Party: Ji Won Han, Associate Professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT03928613     History of Changes
Other Study ID Numbers: B-1903-526-301
First Posted: April 26, 2019    Key Record Dates
Last Update Posted: April 29, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ji Won Han, Seoul National University Bundang Hospital:
Cognitive training
Cognitive intervention
Cognitive rehabilitation

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders