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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All qualified participants | Experimental | Participants received DCTclock, Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and a battery of other traditional pen and paper neuropsychological assessments. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| 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) |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Antonia H Holway, Ph.D. | Digital Cognition Technologies, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Compass Research | Maitland | Florida | 32751 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27037044 | Background | Lamar M, Ajilore O, Leow A, Charlton R, Cohen J, GadElkarim J, Yang S, Zhang A, Davis R, Penney D, Libon DJ, Kumar A. Cognitive and connectome properties detectable through individual differences in graphomotor organization. Neuropsychologia. 2016 May;85:301-9. doi: 10.1016/j.neuropsychologia.2016.03.034. Epub 2016 Mar 30. | |
| 27057085 |
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We do not plan to share IPD
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450 participants were enrolled. 14 did not meet screening criteria.
Participants were enrolled at one site in the US.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Qualified Participants | Participants received the DCTclock test and a battery of other traditional, pen and paper, neuropsychological assessments. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Visit 1 (Primary Endpoint Cohort) |
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| Visit 2 (Secondary Endpoint Cohort) |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants enrolled in the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The Evaluable Population includes all qualified participants undergoing cognitive testing with DCTclock, MMSE, and MoCA who completed visit 1. | Posted | Number | 90% Confidence Interval | Difference in Quadratic Weighted Kappas | Visit 1 (day 1) |
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Adverse event data was collected at each study visit. The second (final) study visit occurred one to four weeks after the first visit, therefore, adverse event data was collected for a period of one to four weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Participants | Participants received DCTclock, MMSE, MoCA, and a battery of other traditional, pen and paper neuropsychological assessments. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bone fracture | Injury, poisoning and procedural complications | Non-systematic Assessment | Accidental fall resulting in bone fracture. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| SVP, Clinical Affairs | Digital Cognition Technologies | 6174331777 | aholway@digitalcogtech.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 19, 2017 | Jan 24, 2018 | SAP_000.pdf |
| Prot | Yes | No | No | Study Protocol | Jan 3, 2018 | Jan 24, 2018 | Prot_001.pdf |
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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.
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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 |
| Visit 1 (day 1) |
| Incidence of Serious Device-related Adverse Events [Safety] | Incidence of serious device-related adverse events. | Visit 1 and visit 2, occuring 1-4 weeks apart |
| Souillard-Mandar W, Davis R, Rudin C, Au R, Libon DJ, Swenson R, Price CC, Lamar M, Penney DL. Learning Classification Models of Cognitive Conditions from Subtle Behaviors in the Digital Clock Drawing Test. Mach Learn. 2016 Mar;102(3):393-441. doi: 10.1007/s10994-015-5529-5. Epub 2015 Oct 20. |
| 25222513 | Background | Cohen J, Penney DL, Davis R, Libon DJ, Swenson RA, Ajilore O, Kumar A, Lamar M. Digital Clock Drawing: differentiating "thinking" versus "doing" in younger and older adults with depression. J Int Neuropsychol Soc. 2014 Oct;20(9):920-8. doi: 10.1017/S1355617714000757. Epub 2014 Sep 15. |
| 27066307 | Background | Davis R, Libon DJ, Au R, Pitman D, Penney DL. THink: Inferring Cognitive Status from Subtle Behaviors. Proc AAAI Conf Artif Intell. 2014 Jul;2014:2898-2905. |
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| years |
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| Sex/Gender, Customized | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Handedness | Count of Participants | Participants |
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| Highest education level attained | Count of Participants | Participants |
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| Units | Counts |
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| Participants |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | Quadratic Weighted Kappa | Visit 1 (day 1) |
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| Secondary | 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. | Version A treats the "Indeterminate" group as "Unimpaired", while version B removes the "Indeterminate" group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population. | Posted | Number | 95% Confidence Interval | Percent Agreement | Visit 1 (day 1) |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | Regression Coefficients | Visit 1 (day 1) |
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| Secondary | Correlation Coefficients on Primary Endpoints | Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA. | Posted | Number | 95% Confidence Interval | Correlation Coefficients | Visit 1 (day 1) |
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| Secondary | 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). | Posted | Number | 95% Confidence Interval | Quadratic Weighted Cohen's Kappa | Visit 1 and visit 2, occurring 1-4 weeks apart |
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| Secondary | 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. | Version A treats the "Indeterminate" group as "Unimpaired", while version B removes the "Indeterminate" group from the analysis. Thus, the analysis population for version B is smaller than the overall analysis population. | Posted | Number | 95% Confidence Interval | Percent Agreement | Visit 1 and visit 2, occurring 1-4 weeks apart |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | Regression Coefficients | Visit 1 and visit 2, occurring 1-4 weeks apart |
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| Secondary | 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. | Posted | Number | 95% Confidence Interval | Correlation Coefficients | Visit 1 and visit 2, occurring 1-4 weeks apart |
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| Other Pre-specified | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | 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. | Includes all qualified participants who completed testing at visit 1 and had evaluable data for each test analyzed. Roughly half of the population was administered the full neuropsychological battery. The remainder completed a partial battery (see protocol for details). | Posted | Number | 95% Confidence Interval | Correlation Coefficient | Visit 1 (day 1) |
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| Other Pre-specified | Incidence of Serious Device-related Adverse Events [Safety] | Incidence of serious device-related adverse events. | All qualified participants who completed at least one DCTclock test. | Posted | Count of Participants | Participants | Visit 1 and visit 2, occuring 1-4 weeks apart |
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| 0 |
| 436 |
| 1 |
| 436 |
| 0 |
| 436 |
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| Positive - Version B |
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| Negative - Version A |
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| Negative - Version B |
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| Rank-Linear - Intercept |
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| Rank-Linear - Slope |
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| Positive - Version B |
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| Negative - Version A |
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| Negative - Version B |
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| Indeterminate |
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| Unimpaired |
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| Linear - Intercept |
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| Linear - Slope |
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| Rank-Linear - Intercept |
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| Rank-Linear - Slope |
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| MoCA |
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| Benton Judgment of Line Orientation |
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| Delis-Kaplan Executive Function- Letter Fluency |
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| Delis-Kaplan Executive Function-Category Fluency |
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| Delis-Kaplan Executive Function-Category Switching |
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| Delis-Kaplan Executive Function- Switch Accuracy |
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| Rey-Osterrieth Complex Figure- Copy |
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| Rey-Osterrieth Complex Figure- Immediate |
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| Rey-Osterrieth Complex Figure- Delayed |
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| Rey-Osterrieth Complex Figure- Immediate Retention |
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| Rey-Osterrieth Complex Figure- Delayed Retention |
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| Rey-Osterrieth Complex Figure- Organization |
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| WAIS-IV Digit Span |
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| WAIS-IV Block Design |
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| Trail Making Part A |
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| Trail Making Part B |
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| Geriatric Depression Scale |
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| Symbol Digit Modalities |
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| Hamilton-Veale Contrast Sensitivity - Left |
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| Hamilton-Veale Contrast Sensitivity- Right |
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| Hamilton-Veale Contrast Sensitivity- Binocular |
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| Purdue Peg Board- Left hand |
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| Purdue Peg Board- Right hand |
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| Purdue Peg Board- Bimanual |
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