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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/14/2021.

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

Clinicaltrials.gov identifier NCT03928613

Recruitment Status Completed

First Posted April 26, 2019

Last update posted March 18, 2020

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

  • Condition or Disease:Mild Cognitive Impairment
  • Intervention/Treatment: Behavioral: tablet based Cognitive Training based on location information
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Actual 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 2019
  • Actual Primary Completion Date: December 2019
  • Actual Study Completion Date: February 2020
Arms and interventions
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
Outcome Measures
  • 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
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Seoul National University Bundang Hospital

Institute of Information & Communications Technology Planning & Evaluation, Korea

Investigators

Principal Investigator: Ji Won Han, M.D., Ph.D. Seoul National University Bundang Hospital

More Information
  • Responsible Party: 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: March 18, 2020
  • Last Verified: March 2020
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Seoul National University Bundang Hospital: Cognitive training
    Cognitive intervention
    Cognitive rehabilitation
  • Additional relevant MeSH terms: Cognitive Dysfunction