- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05634161
Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study
February 7, 2024 updated by: Jun Young Lee, Seoul National University Hospital
Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.
Study Overview
Status
Active, not recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jun-Young Lee, M.D., Ph.D.
- Phone Number: +82 10 5704 6745
- Email: benji@snu.ac.kr
Study Locations
-
-
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Seoul, Korea, Republic of, 156-707
- Seoul Metropolitan Government Seoul National University Boramae Medical Center
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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 to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Cognitively Impaired patients aged 55 to 85, based in South Korea.
Description
Inclusion Criteria:
- Male and Female patients, 55~85 years
- Adequate vision, hearing and speaking for neuropsychological testing
- No difficulty in using mobile application using smartphone
- Patients with subjective memory complaints, confirmed by informants
- Cognitive impairment of SD 1 or greater from the age-adjusted normal range in Memory domain in CERAD-NP battery
- Global CDR 0.5 ~ 1
- Korean speaker
- Have an identified trial partner
- All subjects signed written consent
Exclusion Criteria:
- Those unable to provide consent
- History of transient ischemic attack, stroke, brain tumor
- History of diagnosis of major depression
- Symptoms that may interfere with the subject's testing procedure
- Cerebral hemorrhage
- Central nervous system infections
- Prohibited concomitant medication
- Known or suspected history of drug or alcohol abuse
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
- Observational Models: Other
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Cognitive Improvement software
Usability assessment of cognitive improvement software
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Cognitive improvement software
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Usability: Based on scenarios
Time Frame: Single-point evaluation (baseline)
|
Single-point evaluation (baseline)
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Usability: Based on user survey
Time Frame: Single-point evaluation (baseline)
|
Single-point evaluation (baseline)
|
Usability: Based on hemodynamic responses
Time Frame: Single-point evaluation (baseline)
|
Single-point evaluation (baseline)
|
Changes in Adas-cog
Time Frame: After 12 weeks of system usage
|
After 12 weeks of system usage
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Changes in ADCS-ADL
Time Frame: After 12 weeks of system usage
|
After 12 weeks of system usage
|
Changes in self-reported quality of life
Time Frame: After 12 weeks of system usage
|
After 12 weeks of system usage
|
Changes in blood biomarker
Time Frame: After 12 weeks of system usage
|
After 12 weeks of system usage
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
MMSE
Time Frame: Single-point evaluation (baseline)
|
Single-point evaluation (baseline)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Jun-Young Lee, M.D., Ph.D., Department of Psychiatry, Seoul National University College of Medicine, Department of Psychiatry, SMG-SNU Boramae Medical Center
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 (Actual)
November 21, 2022
Primary Completion (Actual)
March 20, 2023
Study Completion (Estimated)
March 31, 2024
Study Registration Dates
First Submitted
November 21, 2022
First Submitted That Met QC Criteria
November 21, 2022
First Posted (Actual)
December 2, 2022
Study Record Updates
Last Update Posted (Estimated)
February 9, 2024
Last Update Submitted That Met QC Criteria
February 7, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 20-2022-48
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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