- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02848404
Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application
March 23, 2020 updated by: Ki Woong Kim, Seoul National University Bundang Hospital
A Study of Therapeutic Efficacy of Categorical Language Fluency Smartphone Game Application in Mild Cognitive Impairment and Mild Alzheimer's Dementia (Baseline Study)
The purpose of this study is to examine therapeutic efficacy of categorical language fluency smartphone game application in mild cognitive impairment and mild Alzheimer's dementia.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The Categorical Language Fluency Smartphone Game Application was developed based on the semantic distance training, which was effective in improving categorical language fluency of mild cognitive impairment and mild Alzheimer's dementia.
10 patients with mild cognitive impairment and another 10 patients with mild Alzheimer's dementia were recruited to examine therapeutic efficacy of the application.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
55 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged above 55
Confirmed literacy
- Diagnosed to mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.
- Diagnosed to possible or probable Alzheimer's dementia by NINCDS-ADRDA and Clinical Dementia Rating(CDR) of 1 or below.
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
- History of loss-of-consciousness over 1 hour due to head trauma or repetitive head trauma of mild severity
- History of substance abuse or dependence such as alcohol
- Presence of depressive symptoms that could influence cognitive function
- Presence of medical comorbidities that could result in cognitive decline
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Categorical Language Fluency Smartphone Application
Smartphone game application specifically aimed at training categorical language fluency
|
4 weeks' training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Application usage log
Time Frame: 4-weeks treatment
|
Log to assess compliance of participant(by describing frequency and duration of training by using application)
|
4-weeks treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Subjective Memory Complaint Questionnaire
Time Frame: after 4-weeks treatment
|
to evaluate efficacy of application
|
after 4-weeks treatment
|
Geriatric Depression Scale
Time Frame: after 4-weeks treatment
|
to evaluate efficacy of application
|
after 4-weeks treatment
|
Korean version of MMSE for dementia screening
Time Frame: after 4-weeks treatment
|
to evaluate efficacy of application
|
after 4-weeks treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2016
Primary Completion (Actual)
December 1, 2016
Study Completion (Actual)
February 1, 2017
Study Registration Dates
First Submitted
July 20, 2016
First Submitted That Met QC Criteria
July 27, 2016
First Posted (Estimate)
July 28, 2016
Study Record Updates
Last Update Posted (Actual)
March 25, 2020
Last Update Submitted That Met QC Criteria
March 23, 2020
Last Verified
March 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2010-0028631
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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