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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05634161

Enrollment

Registered

2022-12-02

Start date

2022-11-21

Completion date

2024-03-31

Last updated

2024-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Brief summary

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

Interventions

OTHERCognitive improvement software

Cognitive improvement software

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

55 Years to 85 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Usability: Based on scenarios	Single-point evaluation (baseline)

Secondary

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

Other

Measure	Time frame
MMSE	Single-point evaluation (baseline)

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026