Evaluation of DCTclock™ as a Cognitive Assessment Aid

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of DCTclock™ as a Cognitive Assessment Aid

Conditions
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Cognitive Function

Intervention / Treatment
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* Device: DCTclock


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Intervention Model: Single Group Assignment
Interventional Model Description: This study uses a paired design in which each subject undergoes blinded testing by separate testers administering DCTclock and a battery of reference standard tests to determine cognitive state.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All qualified participants<br>Participants received DCTclock, Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and a battery of other traditional pen and paper neuropsychological assessments. | Device: DCTclock<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE) | 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. | Visit 1 (day 1) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quadratic Weighted Kappa on Primary Endpoints | Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA. | Visit 1 (day 1) | 
| Percent Agreement on Primary Endpoints | 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. | Visit 1 (day 1) | 
| Regression Coefficients on Primary Endpoints | 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. | Visit 1 (day 1) | 
| Correlation Coefficients on Primary Endpoints | Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA. | Visit 1 (day 1) | 
| Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability) | Quadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2). | Visit 1 and visit 2, occurring 1-4 weeks apart | 
| Percent Agreement on Secondary Endpoints (Test-retest Reliability) | 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. | Visit 1 and visit 2, occurring 1-4 weeks apart | 
| Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Deming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE. | Visit 1 and visit 2, occurring 1-4 weeks apart | 
| Correlation Coefficients on Secondary Endpoints (Test-retest Reliability) | Pearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI. | Visit 1 and visit 2, occurring 1-4 weeks apart | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cognitive assessment, Cognition, Clock Test