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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Device: DCTclock

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • Compass Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 51 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: All qualified participants; 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; 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).

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Digital Cognition Technologies
• Investigators: Study Director: Antonia H Holway, Ph.D., Digital Cognition Technologies, Inc.

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Davis R, Libon DJ, Au R, Pitman D, Penney DL. THink: Inferring Cognitive Status from Subtle Behaviors. Proc Conf AAAI Artif Intell. 2014 Jul;2014:2898-2905.

Study record dates

Study Major Dates

• Study Start (Actual): July 11, 2017
• Primary Completion (Actual): November 21, 2017
• Study Completion (Actual): November 21, 2017

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: July 31, 2017
• First Posted (Actual): August 3, 2017

Study Record Updates

• Last Update Posted (Actual): April 3, 2018
• Last Update Submitted That Met QC Criteria: March 5, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Cognition; Cognitive assessment; Clock Test
• Other Study ID Numbers: DCT032

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not plan to share IPD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No