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

Mild Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03928613
• Other study ID #: B-1903-526-301
• Status: Completed
• Phase: N/A
• Start date: April 17, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: March 2020
• Source: Seoul National University Bundang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: February 28, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital,	Seongnam-si	Gyeonggi

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Institute of Information & Communications Technology Planning & Evaluation, Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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