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Study to evaluate the accuracy and usefulness of the digital cognitive test 'CQ test' in older Adults

Validation of the clinical utility and psychometric properties of the digital cognitive assessment tool 'CQ test' in older Adults - CQ-VAL Study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCTs042260003
Enrollment
100
Registered
2026-04-09
Start date
2026-04-09
Completion date
Unknown
Last updated
2026-06-29

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

Conditions

Mild cognitive impairment and dementia due to neurodegenerative diseases Mild cognitive impairmant, dementia

Interventions

Use of unauthorized programmed medical device
D012986

Sponsors

Hirohisa Watanabe
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Participants who meet all of the following criteria will be eligible for inclusion in this study. 1. Written informed consent has been obtained from the participant after providing sufficient explanation and ensuring adequate understanding, based on the participant's own free will. 2. Individuals aged 60 years or older (regardless of gender) at the time of obtaining consent. 3. Research subjects must meet one of the following conditions at the time of enrollment: - Individuals who have visited (initial or follow-up) the dementia outpatient clinic (Neurology or Dementia/Geriatrics) at Fujita Health University Hospital and have been diagnosed with, or are suspected of having, mild cognitive impairment (MCI) or dementia. - Healthy elderly people living in the community who have no subjective cognitive decline that interferes with daily life and no history of neurodegenerative disease. 4. Regardless of the use of corrective devices such as glasses or hearing aids, participants must be able to operate digital devices such as tablet terminals required for the CQ test and must have sufficient visual, auditory, and upper limb motor function to recognize and respond to test stimuli. 5. No significant change in health status within 4 weeks prior to enrollment, and judged to be medically stable. 6. If receiving cognitive-enhancing drugs such as cholinesterase inhibitors or psychotropic medications, the dosage and regimen must have been stable for at least 3 months prior to enrollment. otropic medications, the dosage and regimen must have been stable for at least 3 months prior to enrollment.

Exclusion criteria

Exclusion criteria: Participants who meet any of the following criteria will be excluded from the study: 1. Individuals with severe visual, auditory, or upper limb motor impairment that makes it difficult to operate digital devices or to understand the study procedures. 2. Individuals with a history of central nervous system disorders other than the target disease that may significantly affect cognitive function (e.g., brain tumors, traumatic brain injury, acute stroke). 3. Individuals with poorly controlled major psychiatric disorders that may affect cognitive assessment. 4. Individuals with a history of alcohol or illicit drug abuse within the past 6 months, or those using medications that may significantly affect cognitive function or level of consciousness. 5. Individuals currently participating in other interventional studies or cognitive research that may influence cognitive function or study outcomes. 6. Individuals deemed inappropriate for participation by the principal investigator or sub-investigators for any other reason.

Design outcomes

Primary

MeasureTime frame
Correlation between the total CQ test score and the MMSE total score.

Secondary

MeasureTime frame
1. Correlation between total CQ test score and total scores of MMSE, MoCA-J, and ACE-R. 2. Sensitivity and specificity of CQ test for detecting MCI and early dementia compared with MMSE, MoCA-J, and ACE-R. 3. Assessment time and performance metrics of CQ test. 4. Examiner usability evaluation of CQ test. 5. Participant questionnaire on burden and usability. 6. Correlation between CQ test domain subscores and MMSE domain subscores. 7. Correlation between CQ test and MMSE scores stratified by MMSE severity categories.

Contacts

Public ContactHirohisa Watanabe

Fujita Health University Hospital

hirohisa.watanabe@fujita-hu.ac.jp+81-562-93-9295

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026