Cognitive Function
Conditions
Keywords
Cognitive assessment, Cognition, Clock Test
Brief summary
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.
Interventions
DEVICEDCTclock
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).
Sponsors
Digital Cognition Technologies
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
55 Years to 95 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Quadratic Weighted Kappa on Primary Endpoints | Visit 1 (day 1) | Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA. |
| Percent Agreement on Primary Endpoints | 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. |
| Regression Coefficients on Primary Endpoints | 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. |
| Correlation Coefficients on Primary Endpoints | Visit 1 (day 1) | Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA. |
| Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | 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. |
| Correlation Coefficients on Secondary Endpoints (Test-retest Reliability) | 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. |
| Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability) | 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). |
| Percent Agreement on Secondary Endpoints (Test-retest Reliability) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | 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. |
| Incidence of Serious Device-related Adverse Events [Safety] | Visit 1 and visit 2, occuring 1-4 weeks apart | Incidence of serious device-related adverse events. |
Countries
United States
Participant flow
Recruitment details
Participants were enrolled at one site in the US.
Pre-assignment details
450 participants were enrolled. 14 did not meet screening criteria.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants enrolled in the study. | 450 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Visit 1 (Primary Endpoint Cohort) | Protocol Violation | 2 |
| Visit 1 (Primary Endpoint Cohort) | Unanalyzable test result | 2 |
| Visit 2 (Secondary Endpoint Cohort) | Lost to Follow-up | 16 |
| Visit 2 (Secondary Endpoint Cohort) | Met exclusion criteria at visit 2 | 3 |
| Visit 2 (Secondary Endpoint Cohort) | Protocol Violation | 4 |
| Visit 2 (Secondary Endpoint Cohort) | Study completion | 1 |
| Visit 2 (Secondary Endpoint Cohort) | Unanalyzable test result | 2 |
| Visit 2 (Secondary Endpoint Cohort) | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | All Participants |
|---|---|
| Age, Continuous | 68.94 years STANDARD_DEVIATION 8.78 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 38 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 405 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 7 Participants |
| Handedness Ambidextrous | 13 Participants |
| Handedness Left handed | 34 Participants |
| Handedness Other or unknown | 7 Participants |
| Handedness Right handed | 396 Participants |
| Highest education level attained College Degree + | 148 Participants |
| Highest education level attained High school | 106 Participants |
| Highest education level attained High School and some college | 141 Participants |
| Highest education level attained Less than high school | 45 Participants |
| Highest education level attained Unknown | 10 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 105 Participants |
| Race (NIH/OMB) More than one race | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) White | 329 Participants |
| Sex/Gender, Customized Female | 333 Participants |
| Sex/Gender, Customized Male | 114 Participants |
| Sex/Gender, Customized Unknown or Other | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 436 |
| other Total, other adverse events | 0 / 436 |
| serious Total, serious adverse events | 1 / 436 |
Outcome results
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.
Time frame: Visit 1 (day 1)
Population: The Evaluable Population includes all qualified participants undergoing cognitive testing with DCTclock, MMSE, and MoCA who completed visit 1.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Endpoint (Evaluable) Population | Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE) | -0.035 Difference in Quadratic Weighted Kappas |
Comparison: A two-one-sided tests approach was taken, where, prior to analysis, it was determined that a delta (equivalence margin) of 0.20 would be considered a significant difference between the DCTclock/MoCA kappa and the MMSE/MoCA kappa. The reasoning behind this determination can be found in the study's statistical analysis plan.90% CI: [-0.12, 0.05]
Secondary
Correlation Coefficients on Primary Endpoints
Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.
Time frame: Visit 1 (day 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Endpoint (Evaluable) Population | Correlation Coefficients on Primary Endpoints | Pearson | 0.53 Correlation Coefficients |
| Primary Endpoint (Evaluable) Population | Correlation Coefficients on Primary Endpoints | Spearman | 0.50 Correlation Coefficients |
| MMSE | Correlation Coefficients on Primary Endpoints | Pearson | 0.59 Correlation Coefficients |
| MMSE | Correlation Coefficients on Primary Endpoints | Spearman | 0.55 Correlation Coefficients |
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.
Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Endpoint (Evaluable) Population | Correlation Coefficients on Secondary Endpoints (Test-retest Reliability) | Pearson | 0.70 Correlation Coefficients |
| Primary Endpoint (Evaluable) Population | Correlation Coefficients on Secondary Endpoints (Test-retest Reliability) | Spearman | 0.67 Correlation Coefficients |
| MMSE | Correlation Coefficients on Secondary Endpoints (Test-retest Reliability) | Pearson | 0.67 Correlation Coefficients |
| MMSE | Correlation Coefficients on Secondary Endpoints (Test-retest Reliability) | Spearman | 0.56 Correlation Coefficients |
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.
Time frame: Visit 1 (day 1)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Endpoint (Evaluable) Population | Percent Agreement on Primary Endpoints | Positive - Version A | 0.64 Percent Agreement |
| Primary Endpoint (Evaluable) Population | Percent Agreement on Primary Endpoints | Positive - Version B | 0.78 Percent Agreement |
| Primary Endpoint (Evaluable) Population | Percent Agreement on Primary Endpoints | Negative - Version A | 0.74 Percent Agreement |
| Primary Endpoint (Evaluable) Population | Percent Agreement on Primary Endpoints | Negative - Version B | 0.73 Percent Agreement |
| MMSE | Percent Agreement on Primary Endpoints | Negative - Version B | 0.88 Percent Agreement |
| MMSE | Percent Agreement on Primary Endpoints | Positive - Version A | 0.56 Percent Agreement |
| MMSE | Percent Agreement on Primary Endpoints | Negative - Version A | 0.83 Percent Agreement |
| MMSE | Percent Agreement on Primary Endpoints | Positive - Version B | 0.69 Percent Agreement |
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.
Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Endpoint (Evaluable) Population | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Positive - Version A | 0.73 Percent Agreement |
| Primary Endpoint (Evaluable) Population | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Positive - Version B | 0.85 Percent Agreement |
| Primary Endpoint (Evaluable) Population | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Negative - Version A | 0.76 Percent Agreement |
| Primary Endpoint (Evaluable) Population | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Negative - Version B | 0.81 Percent Agreement |
| Primary Endpoint (Evaluable) Population | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Indeterminate | 0.21 Percent Agreement |
| Primary Endpoint (Evaluable) Population | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Unimpaired | 0.61 Percent Agreement |
| MMSE | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Indeterminate | 0.27 Percent Agreement |
| MMSE | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Positive - Version A | 0.74 Percent Agreement |
| MMSE | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Negative - Version B | 0.78 Percent Agreement |
| MMSE | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Positive - Version B | 0.84 Percent Agreement |
| MMSE | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Unimpaired | 0.63 Percent Agreement |
| MMSE | Percent Agreement on Secondary Endpoints (Test-retest Reliability) | Negative - Version A | 0.80 Percent Agreement |
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.
Time frame: Visit 1 (day 1)
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Endpoint (Evaluable) Population | Quadratic Weighted Kappa on Primary Endpoints | 0.40 Quadratic Weighted Kappa |
| MMSE | Quadratic Weighted Kappa on Primary Endpoints | 0.44 Quadratic Weighted Kappa |
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).
Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Primary Endpoint (Evaluable) Population | Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability) | 0.53 Quadratic Weighted Cohen's Kappa |
| MMSE | Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability) | 0.48 Quadratic Weighted Cohen's Kappa |
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.
Time frame: Visit 1 (day 1)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Primary Endpoints | Linear - Intercept | 19.35 Regression Coefficients |
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Primary Endpoints | Linear - Slope | 0.07 Regression Coefficients |
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Primary Endpoints | Rank-Linear - Intercept | 107.75 Regression Coefficients |
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Primary Endpoints | Rank-Linear - Slope | 0.50 Regression Coefficients |
| MMSE | Regression Coefficients on Primary Endpoints | Rank-Linear - Slope | 0.55 Regression Coefficients |
| MMSE | Regression Coefficients on Primary Endpoints | Linear - Intercept | -5.03 Regression Coefficients |
| MMSE | Regression Coefficients on Primary Endpoints | Rank-Linear - Intercept | 96.45 Regression Coefficients |
| MMSE | Regression Coefficients on Primary Endpoints | Linear - Slope | 1.03 Regression Coefficients |
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.
Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Deming - Intercept | 8.77 Regression Coefficients |
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Deming - Slope | 0.93 Regression Coefficients |
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Linear - Intercept | 25.03 Regression Coefficients |
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Linear - Slope | 0.66 Regression Coefficients |
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Rank-Linear - Intercept | 66.48 Regression Coefficients |
| Primary Endpoint (Evaluable) Population | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Rank-Linear - Slope | 0.67 Regression Coefficients |
| MMSE | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Rank-Linear - Intercept | 91.16 Regression Coefficients |
| MMSE | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Deming - Intercept | 2.96 Regression Coefficients |
| MMSE | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Linear - Slope | 0.62 Regression Coefficients |
| MMSE | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Deming - Slope | 0.91 Regression Coefficients |
| MMSE | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Rank-Linear - Slope | 0.55 Regression Coefficients |
| MMSE | Regression Coefficients on Secondary Endpoints (Test-retest Reliability) | Linear - Intercept | 10.88 Regression Coefficients |
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.
Time frame: Visit 1 (day 1)
Population: 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).
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Benton Judgment of Line Orientation | 0.34 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | WAIS-IV Digit Span | 0.32 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Copy | 0.44 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | WAIS-IV Block Design | 0.39 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Delis-Kaplan Executive Function-Category Fluency | 0.39 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Trail Making Part A | 0.48 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Immediate | 0.43 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Trail Making Part B | 0.49 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | MoCA | 0.53 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Geriatric Depression Scale | -0.11 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Delayed | 0.39 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Symbol Digit Modalities | 0.51 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Delis-Kaplan Executive Function-Category Switching | 0.30 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Hamilton-Veale Contrast Sensitivity - Left | 0.12 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Immediate Retention | 0.22 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Hamilton-Veale Contrast Sensitivity- Right | 0.09 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Delis-Kaplan Executive Function- Letter Fluency | 0.36 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Hamilton-Veale Contrast Sensitivity- Binocular | 0.24 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Delayed Retention | -0.06 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Purdue Peg Board- Left hand | 0.32 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Delis-Kaplan Executive Function- Switch Accuracy | 0.26 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Purdue Peg Board- Right hand | 0.35 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Organization | 0.29 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Purdue Peg Board- Bimanual | 0.36 Correlation Coefficient |
| Primary Endpoint (Evaluable) Population | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | MMSE | 0.50 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Purdue Peg Board- Bimanual | 0.25 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | MMSE | NA Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | MoCA | 0.59 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Benton Judgment of Line Orientation | 0.36 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Delis-Kaplan Executive Function- Letter Fluency | 0.34 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Delis-Kaplan Executive Function-Category Fluency | 0.37 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Delis-Kaplan Executive Function-Category Switching | 0.38 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Delis-Kaplan Executive Function- Switch Accuracy | 0.36 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Copy | 0.43 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Immediate | 0.31 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Delayed | 0.28 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Immediate Retention | 0.08 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Delayed Retention | 0.03 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Rey-Osterrieth Complex Figure- Organization | 0.25 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | WAIS-IV Digit Span | 0.48 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | WAIS-IV Block Design | 0.42 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Trail Making Part A | 0.45 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Trail Making Part B | 0.51 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Geriatric Depression Scale | -0.04 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Symbol Digit Modalities | 0.49 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Hamilton-Veale Contrast Sensitivity - Left | 0.10 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Hamilton-Veale Contrast Sensitivity- Right | 0.17 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Hamilton-Veale Contrast Sensitivity- Binocular | 0.21 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Purdue Peg Board- Left hand | 0.16 Correlation Coefficient |
| MMSE | Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments | Purdue Peg Board- Right hand | 0.22 Correlation Coefficient |
Other Pre-specified
Incidence of Serious Device-related Adverse Events [Safety]
Incidence of serious device-related adverse events.
Time frame: Visit 1 and visit 2, occuring 1-4 weeks apart
Population: All qualified participants who completed at least one DCTclock test.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Primary Endpoint (Evaluable) Population | Incidence of Serious Device-related Adverse Events [Safety] | 0 Participants |