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Completed

NCT Number: NCT03238001

Evaluation of DCTclock™ as a Cognitive Assessment Aid

The overall objective of this study is to demonstrate the safety and effectiveness of DCTclock as an adjunctive tool for use by clinicians to evaluate cognitive function in adults aged 55-95.

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Key information

Conditions

Cognitive Function

Age range

55 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Compass Research

Maitland, Florida, 32751, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Men and women 55 to 95 years old.

Exclusion criteria

  • Ineligible for written informed consent.
  • Physical impairment of the writing hand.
  • Impaired manual dexterity.
  • Impaired vision.
  • Under the influence of recreational drugs or alcohol at the time of the visit.
  • Current or recent participation in a clinical trial that includes the use of a drug or intervention to alter cognitive function.
  • Recent cognitive testing.

Treatment and study plan

DCTclock

Device

DCTclock is a quick and non-invasive test that measures cognitive function based on a computerized algorithmic analysis of the entire drawing process and output of a well-established cognitive assessment called The Clock Drawing Test (CDT).

Primary outcomes

  1. Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)

    Time frame: Visit 1 (day 1)

    The primary analysis will assess agreement between DCTclock and the Montreal Cognitive Assessment (MoCA) and compare it to the agreement between the MMSE and MoCA at visit 1.

Secondary outcomes

  1. Quadratic Weighted Kappa on Primary Endpoints

    Time frame: Visit 1 (day 1)

    Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA.

  2. Percent Agreement on Primary Endpoints

    Time frame: Visit 1 (day 1)

    Positive percent agreement, version A (treating the "Indeterminate" group as "Unimpaired") and version B (removing the "Indeterminate" group from the analysis), and negative percent agreement version A and version B. These were calculated for the DCTclock/MoCA classification table as well as the MMSE/MoCA classification table. 95% CI were also calculated and compared between the two classification tables' calculations.

  3. Regression Coefficients on Primary Endpoints

    Time frame: Visit 1 (day 1)

    Linear and rank-linear regression coefficients (slope, intercept) and 95% CI for DCTclock regressed on MoCA as well as for the MMSE regressed on MoCA.

  4. Correlation Coefficients on Primary Endpoints

    Time frame: Visit 1 (day 1)

    Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.

  5. Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)

    Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart

    Quadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2).

  6. Percent Agreement on Secondary Endpoints (Test-retest Reliability)

    Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart

    Positive percent agreement version A (treating the "Indeterminate" group as "Unimpaired") and version B (removing the "Indeterminate" group from the analysis), negative percent agreement version A and version B, indeterminate percent agreement, and unimpaired percent agreement.

  7. Regression Coefficients on Secondary Endpoints (Test-retest Reliability)

    Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart

    Deming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE.

  8. Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)

    Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart

    Pearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI.

Other outcomes

  1. Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments

    Time frame: Visit 1 (day 1)

    The goal of this analysis is to assess the construct validity of DCTclock. Specifically, the goal is to compare scores from the administration of DCTclock to the visit 1 administration of a battery of neuropsychological tests, to characterize the psychometric properties of DCTclock, and to compare those properties to the properties of MMSE.

  2. Incidence of Serious Device-related Adverse Events [Safety]

    Time frame: Visit 1 and visit 2, occuring 1-4 weeks apart

    Incidence of serious device-related adverse events.

Sponsors and collaborators

Lead sponsor

Digital Cognition Technologies

Industry

Registry information

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Aug 3, 2017
Registry last updated
Apr 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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