Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study

Mild Cognitive Impairment Clinical Trial

Official title:

Usability of Cognitive Improvement Software in Cognitively Impaired Patients: Pilot Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05634161
• Other study ID #: 20-2022-48
• Status: Active, not recruiting
• Start date: November 21, 2022
• Est. completion date: March 31, 2024

Study information

• Verified date: February 2024
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Usability study of software application that provide digitized cognitive intervention therapy for cognitively impaired patients.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: March 31, 2024
• Est. primary completion date: March 20, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Mild Cognitive Impairment

Intervention

Other:
• Cognitive improvement software
Cognitive improvement software

Locations

Country	Name	City	State
Korea, Republic of	Seoul Metropolitan Government Seoul National University Boramae Medical Center	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Seoul National University Boramae Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	MMSE		Single-point evaluation (baseline)
Primary	Usability: Based on scenarios		Single-point evaluation (baseline)
Secondary	Usability: Based on user survey		Single-point evaluation (baseline)
Secondary	Usability: Based on hemodynamic responses		Single-point evaluation (baseline)
Secondary	Changes in Adas-cog		After 12 weeks of system usage
Secondary	Changes in ADCS-ADL		After 12 weeks of system usage
Secondary	Changes in self-reported quality of life		After 12 weeks of system usage
Secondary	Changes in blood biomarker		After 12 weeks of system usage