Trial Outcomes & Findings for Evaluation of DCTclock™ as a Cognitive Assessment Aid (NCT NCT03238001)
NCT ID: NCT03238001
Last Updated: 2018-04-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
450 participants
Primary outcome timeframe
Visit 1 (day 1)
Results posted on
2018-04-03
Participant Flow
Participants were enrolled at one site in the US.
450 participants were enrolled. 14 did not meet screening criteria.
Participant milestones
| Measure |
All Qualified Participants
Participants received the DCTclock test and a battery of other traditional, pen and paper, neuropsychological assessments.
|
|---|---|
|
Visit 1 (Primary Endpoint Cohort)
STARTED
|
436
|
|
Visit 1 (Primary Endpoint Cohort)
COMPLETED
|
432
|
|
Visit 1 (Primary Endpoint Cohort)
NOT COMPLETED
|
4
|
|
Visit 2 (Secondary Endpoint Cohort)
STARTED
|
432
|
|
Visit 2 (Secondary Endpoint Cohort)
COMPLETED
|
403
|
|
Visit 2 (Secondary Endpoint Cohort)
NOT COMPLETED
|
29
|
Reasons for withdrawal
| Measure |
All Qualified Participants
Participants received the DCTclock test and a battery of other traditional, pen and paper, neuropsychological assessments.
|
|---|---|
|
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)
Unanalyzable test result
|
2
|
|
Visit 2 (Secondary Endpoint Cohort)
Withdrawal by Subject
|
3
|
|
Visit 2 (Secondary Endpoint Cohort)
Met exclusion criteria at visit 2
|
3
|
|
Visit 2 (Secondary Endpoint Cohort)
Study completion
|
1
|
|
Visit 2 (Secondary Endpoint Cohort)
Protocol Violation
|
4
|
Baseline Characteristics
Evaluation of DCTclock™ as a Cognitive Assessment Aid
Baseline characteristics by cohort
| Measure |
All Participants
n=450 Participants
All participants enrolled in the study.
|
|---|---|
|
Age, Continuous
|
68.94 years
STANDARD_DEVIATION 8.78 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
114 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
333 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Unknown or Other
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
38 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
405 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
105 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
329 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
|
Handedness
Right handed
|
396 Participants
n=5 Participants
|
|
Handedness
Left handed
|
34 Participants
n=5 Participants
|
|
Handedness
Ambidextrous
|
13 Participants
n=5 Participants
|
|
Handedness
Other or unknown
|
7 Participants
n=5 Participants
|
|
Highest education level attained
College Degree +
|
148 Participants
n=5 Participants
|
|
Highest education level attained
High School and some college
|
141 Participants
n=5 Participants
|
|
Highest education level attained
High school
|
106 Participants
n=5 Participants
|
|
Highest education level attained
Less than high school
|
45 Participants
n=5 Participants
|
|
Highest education level attained
Unknown
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Visit 1 (day 1)Population: The Evaluable Population includes all qualified participants undergoing cognitive testing with DCTclock, MMSE, and MoCA who completed visit 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.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=432 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)
|
-0.035 Difference in Quadratic Weighted Kappas
Interval -0.12 to 0.05
|
—
|
SECONDARY outcome
Timeframe: Visit 1 (day 1)Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=432 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
n=432 Participants
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Quadratic Weighted Kappa on Primary Endpoints
|
0.40 Quadratic Weighted Kappa
Interval 0.32 to 0.49
|
0.44 Quadratic Weighted Kappa
Interval 0.36 to 0.52
|
SECONDARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=432 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
n=432 Participants
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Percent Agreement on Primary Endpoints
Positive - Version A
|
0.64 Percent Agreement
Interval 0.57 to 0.71
|
0.56 Percent Agreement
Interval 0.49 to 0.63
|
|
Percent Agreement on Primary Endpoints
Positive - Version B
|
0.78 Percent Agreement
Interval 0.71 to 0.84
|
0.69 Percent Agreement
Interval 0.62 to 0.76
|
|
Percent Agreement on Primary Endpoints
Negative - Version A
|
0.74 Percent Agreement
Interval 0.69 to 0.8
|
0.83 Percent Agreement
Interval 0.78 to 0.87
|
|
Percent Agreement on Primary Endpoints
Negative - Version B
|
0.73 Percent Agreement
Interval 0.64 to 0.81
|
0.88 Percent Agreement
Interval 0.81 to 0.93
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=432 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
n=432 Participants
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Regression Coefficients on Primary Endpoints
Linear - Intercept
|
19.35 Regression Coefficients
Interval 18.64 to 20.07
|
-5.03 Regression Coefficients
Interval -8.73 to -1.32
|
|
Regression Coefficients on Primary Endpoints
Linear - Slope
|
0.07 Regression Coefficients
Interval 0.06 to 0.08
|
1.03 Regression Coefficients
Interval 0.9 to 1.17
|
|
Regression Coefficients on Primary Endpoints
Rank-Linear - Intercept
|
107.75 Regression Coefficients
Interval 87.37 to 128.12
|
96.45 Regression Coefficients
Interval 76.43 to 116.48
|
|
Regression Coefficients on Primary Endpoints
Rank-Linear - Slope
|
0.50 Regression Coefficients
Interval 0.42 to 0.58
|
0.55 Regression Coefficients
Interval 0.47 to 0.63
|
SECONDARY outcome
Timeframe: Visit 1 (day 1)Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=432 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
n=432 Participants
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Correlation Coefficients on Primary Endpoints
Pearson
|
0.53 Correlation Coefficients
Interval 0.46 to 0.6
|
0.59 Correlation Coefficients
Interval 0.53 to 0.65
|
|
Correlation Coefficients on Primary Endpoints
Spearman
|
0.50 Correlation Coefficients
Interval 0.43 to 0.57
|
0.55 Correlation Coefficients
Interval 0.48 to 0.61
|
SECONDARY outcome
Timeframe: Visit 1 and visit 2, occurring 1-4 weeks apartQuadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2).
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=403 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
n=403 Participants
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)
|
0.53 Quadratic Weighted Cohen's Kappa
Interval 0.45 to 0.6
|
0.48 Quadratic Weighted Cohen's Kappa
Interval 0.39 to 0.56
|
SECONDARY outcome
Timeframe: Visit 1 and visit 2, occurring 1-4 weeks apartPopulation: 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.
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.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=403 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
n=403 Participants
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Percent Agreement on Secondary Endpoints (Test-retest Reliability)
Positive - Version A
|
0.73 Percent Agreement
Interval 0.66 to 0.8
|
0.74 Percent Agreement
Interval 0.65 to 0.82
|
|
Percent Agreement on Secondary Endpoints (Test-retest Reliability)
Positive - Version B
|
0.85 Percent Agreement
Interval 0.77 to 0.9
|
0.84 Percent Agreement
Interval 0.75 to 0.9
|
|
Percent Agreement on Secondary Endpoints (Test-retest Reliability)
Negative - Version A
|
0.76 Percent Agreement
Interval 0.7 to 0.81
|
0.80 Percent Agreement
Interval 0.75 to 0.84
|
|
Percent Agreement on Secondary Endpoints (Test-retest Reliability)
Negative - Version B
|
0.81 Percent Agreement
Interval 0.74 to 0.87
|
0.78 Percent Agreement
Interval 0.72 to 0.84
|
|
Percent Agreement on Secondary Endpoints (Test-retest Reliability)
Indeterminate
|
0.21 Percent Agreement
Interval 0.14 to 0.31
|
0.27 Percent Agreement
Interval 0.17 to 0.39
|
|
Percent Agreement on Secondary Endpoints (Test-retest Reliability)
Unimpaired
|
0.61 Percent Agreement
Interval 0.54 to 0.68
|
0.63 Percent Agreement
Interval 0.57 to 0.69
|
SECONDARY outcome
Timeframe: Visit 1 and visit 2, occurring 1-4 weeks apartDeming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=403 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
n=403 Participants
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Regression Coefficients on Secondary Endpoints (Test-retest Reliability)
Deming - Intercept
|
8.77 Regression Coefficients
Interval 3.07 to 14.46
|
2.96 Regression Coefficients
Interval -0.46 to 6.37
|
|
Regression Coefficients on Secondary Endpoints (Test-retest Reliability)
Deming - Slope
|
0.93 Regression Coefficients
Interval 0.85 to 1.0
|
0.91 Regression Coefficients
Interval 0.79 to 1.03
|
|
Regression Coefficients on Secondary Endpoints (Test-retest Reliability)
Linear - Intercept
|
25.03 Regression Coefficients
Interval 20.58 to 29.48
|
10.88 Regression Coefficients
Interval 8.96 to 12.8
|
|
Regression Coefficients on Secondary Endpoints (Test-retest Reliability)
Linear - Slope
|
0.66 Regression Coefficients
Interval 0.6 to 0.73
|
0.62 Regression Coefficients
Interval 0.55 to 0.69
|
|
Regression Coefficients on Secondary Endpoints (Test-retest Reliability)
Rank-Linear - Intercept
|
66.48 Regression Coefficients
Interval 49.51 to 83.46
|
91.16 Regression Coefficients
Interval 72.43 to 109.89
|
|
Regression Coefficients on Secondary Endpoints (Test-retest Reliability)
Rank-Linear - Slope
|
0.67 Regression Coefficients
Interval 0.6 to 0.74
|
0.55 Regression Coefficients
Interval 0.47 to 0.63
|
SECONDARY outcome
Timeframe: Visit 1 and visit 2, occurring 1-4 weeks apartPearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=403 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
n=403 Participants
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)
Pearson
|
0.70 Correlation Coefficients
Interval 0.64 to 0.75
|
0.67 Correlation Coefficients
Interval 0.61 to 0.72
|
|
Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)
Spearman
|
0.67 Correlation Coefficients
Interval 0.6 to 0.73
|
0.56 Correlation Coefficients
Interval 0.47 to 0.62
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 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).
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.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=432 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
n=432 Participants
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
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
Interval 0.42 to 0.57
|
NA Correlation Coefficient
Row = Column (correlation of MMSE to MMSE)
|
|
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
Interval 0.46 to 0.6
|
0.59 Correlation Coefficient
Interval 0.53 to 0.65
|
|
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
Interval 0.21 to 0.46
|
0.36 Correlation Coefficient
Interval 0.23 to 0.48
|
|
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
Interval 0.23 to 0.48
|
0.34 Correlation Coefficient
Interval 0.21 to 0.46
|
|
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
Interval 0.27 to 0.5
|
0.37 Correlation Coefficient
Interval 0.24 to 0.49
|
|
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
Interval 0.16 to 0.42
|
0.38 Correlation Coefficient
Interval 0.25 to 0.49
|
|
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
Interval 0.13 to 0.39
|
0.36 Correlation Coefficient
Interval 0.24 to 0.48
|
|
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
Interval 0.31 to 0.55
|
0.43 Correlation Coefficient
Interval 0.31 to 0.55
|
|
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
Interval 0.31 to 0.54
|
0.31 Correlation Coefficient
Interval 0.17 to 0.43
|
|
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
Interval 0.26 to 0.5
|
0.28 Correlation Coefficient
Interval 0.14 to 0.4
|
|
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
Interval 0.08 to 0.35
|
0.08 Correlation Coefficient
Interval -0.06 to 0.22
|
|
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
Interval -0.2 to 0.09
|
0.03 Correlation Coefficient
Interval -0.11 to 0.17
|
|
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
Interval 0.16 to 0.42
|
0.25 Correlation Coefficient
Interval 0.11 to 0.38
|
|
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
Interval 0.23 to 0.4
|
0.48 Correlation Coefficient
Interval 0.4 to 0.55
|
|
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
Interval 0.27 to 0.51
|
0.42 Correlation Coefficient
Interval 0.29 to 0.53
|
|
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
Interval 0.4 to 0.55
|
0.45 Correlation Coefficient
Interval 0.38 to 0.53
|
|
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
Interval 0.41 to 0.56
|
0.51 Correlation Coefficient
Interval 0.44 to 0.58
|
|
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
Interval -0.24 to 0.03
|
-0.04 Correlation Coefficient
Interval -0.18 to 0.1
|
|
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
Interval 0.39 to 0.6
|
0.49 Correlation Coefficient
Interval 0.37 to 0.59
|
|
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
Interval 0.03 to 0.22
|
0.10 Correlation Coefficient
Interval 0.01 to 0.19
|
|
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
Interval 0.0 to 0.18
|
0.17 Correlation Coefficient
Interval 0.08 to 0.26
|
|
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
Interval 0.14 to 0.32
|
0.21 Correlation Coefficient
Interval 0.11 to 0.29
|
|
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
Interval 0.24 to 0.41
|
0.16 Correlation Coefficient
Interval 0.07 to 0.25
|
|
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
Interval 0.27 to 0.43
|
0.22 Correlation Coefficient
Interval 0.12 to 0.3
|
|
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
Interval 0.28 to 0.44
|
0.25 Correlation Coefficient
Interval 0.16 to 0.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Visit 1 and visit 2, occuring 1-4 weeks apartPopulation: All qualified participants who completed at least one DCTclock test.
Incidence of serious device-related adverse events.
Outcome measures
| Measure |
Primary Endpoint (Evaluable) Population
n=432 Participants
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional pen and paper neuropsychological assessments.
|
MMSE
Participants received MMSE and MoCA on their first visit.
|
|---|---|---|
|
Incidence of Serious Device-related Adverse Events [Safety]
|
0 Participants
|
—
|
Adverse Events
All Participants
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
All Participants
n=436 participants at risk
Participants received DCTclock, MMSE, MoCA, and a battery of other traditional, pen and paper neuropsychological assessments.
|
|---|---|
|
Injury, poisoning and procedural complications
Bone fracture
|
0.23%
1/436 • Number of events 1 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER