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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02848404
Other study ID # 2010-0028631
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 2016
Est. completion date February 2017

Study information

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

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date February 2017
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender All
Age group 55 Years and older
Eligibility 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 Design


Intervention

Device:
Categorical Language Fluency Smartphone Application
4 weeks' training

Locations

Country Name City State
n/a

Sponsors (3)

Lead Sponsor Collaborator
Seoul National University Bundang Hospital Ministry of Science, ICT and Future Planning, Seoul National University

Outcome

Type Measure Description Time frame Safety issue
Primary Application usage log Log to assess compliance of participant(by describing frequency and duration of training by using application) 4-weeks treatment
Secondary Subjective Memory Complaint Questionnaire to evaluate efficacy of application after 4-weeks treatment
Secondary Geriatric Depression Scale to evaluate efficacy of application after 4-weeks treatment
Secondary Korean version of MMSE for dementia screening to evaluate efficacy of application after 4-weeks treatment
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