NCT02848404

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

July 28, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2017

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

6 months

First QC Date

July 20, 2016

Last Update Submit

March 23, 2020

Conditions

Mild Cognitive ImpairmentAlzheimer's Disease

Keywords

Mild cognitive impairmentCognitive rehabilitationCognitive therapyAlzheimer's diseaseMemory enhancementCategorical language fluency

Outcome Measures

Primary Outcomes (1)

  • Application usage log

    Log to assess compliance of participant(by describing frequency and duration of training by using application)

    4-weeks treatment

Secondary Outcomes (3)

  • Subjective Memory Complaint Questionnaire

    after 4-weeks treatment

  • Geriatric Depression Scale

    after 4-weeks treatment

  • Korean version of MMSE for dementia screening

    after 4-weeks treatment

Study Arms (1)

Categorical Language Fluency Smartphone Application

EXPERIMENTAL

Smartphone game application specifically aimed at training categorical language fluency

Device: Categorical Language Fluency Smartphone Application

Interventions

Categorical Language Fluency Smartphone ApplicationDEVICE

4 weeks' training

Categorical Language Fluency Smartphone Application

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Cognitive DysfunctionAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Officials

  • Ki Woong Kim, M.D., Ph.D.

    Seoul National University Bundang Hospital, Seong-nam, Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, department of neuropsychiatry

Study Record Dates

First Submitted

July 20, 2016

First Posted

July 28, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2016

Study Completion

February 1, 2017

Last Updated

March 25, 2020

Record last verified: 2020-03