Mild Cognitive ImpairmentNCT05634161
Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study
An observational study of Mild Cognitive Impairment, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients. Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Cognitive improvement software
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- 21 Nov 2022to 31 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cognitively Impaired patients aged 55 to 85, based in South Korea.
Who may be able to join
- 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
Show all 9Show fewer
- Korean speaker
- Have an identified trial partner
- All subjects signed written consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul Metropolitan Government Seoul National University Boramae Medical Center
Seoul, 156-707
About this study
Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Cognitive improvement software
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive improvement softwareOther
Cognitive improvement software
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Improvement software | Usability assessment of cognitive improvement software Receives: Other: Cognitive improvement software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Usability: Based on scenarios
Measured: Single-point evaluation (baseline)
Secondary outcomes (6)
Usability: Based on user survey
Measured: Single-point evaluation (baseline)
Usability: Based on hemodynamic responses
Measured: Single-point evaluation (baseline)
Changes in Adas-cog
Measured: After 12 weeks of system usage
Changes in ADCS-ADL
Measured: After 12 weeks of system usage
Changes in self-reported quality of life
Measured: After 12 weeks of system usage
Changes in blood biomarker
Measured: After 12 weeks of system usage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start21 Nov 2022
- Primary completion20 Mar 2023
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Boramae Hospital
- Responsible party
- Principal investigator, Jun Young Lee, Seoul National University Boramae Hospital
- Investigators
- Jun-Young Lee, M.D., Ph.D., Principal investigator, Department of Psychiatry, Seoul National University College of Medicine, Department of Psychiatry, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05634161
- Sponsor's protocol ID
- 20-2022-48
- Status last verified
- Feb 2024
- First submitted
- 21 Nov 2022
- Last updated
- 9 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study
- ClinicalTrials.gov ID
- NCT05634161
- Acronym / sponsor ID
- 20-2022-48
- Conditions
- Mild Cognitive Impairment
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Boramae Hospital
- Study start
- 21 Nov 2022 (actual)
- Primary completion
- 20 Mar 2023 (actual)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cognitive Improvement software | – | Other: Cognitive improvement softwareUsability assessment of cognitive improvement software |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cognitively Impaired patients aged 55 to 85, based in South Korea.
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive improvement softwareCognitive improvement software | Other | Cognitive Improvement software |
Primary outcome
Usability: Based on scenarios
Time frame: Single-point evaluation (baseline)
6 secondary outcomes
Usability: Based on user survey
Time frame: Single-point evaluation (baseline)
Usability: Based on hemodynamic responses
Time frame: Single-point evaluation (baseline)
Changes in Adas-cog
Time frame: After 12 weeks of system usage
Changes in ADCS-ADL
Time frame: After 12 weeks of system usage
Changes in self-reported quality of life
Time frame: After 12 weeks of system usage
Changes in blood biomarker
Time frame: After 12 weeks of system usage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jun-Young Lee, M.D., Ph.D. principal investigator
Department of Psychiatry, Seoul National University College of Medicine, Department of Psychiatry, SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mild Cognitive Impairment, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Usability: Based on scenarios (time frame: Single-point evaluation (baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2024.