Evaluation of DCTclock™ as a Cognitive Assessment Aid

Cognitive Function Clinical Trial

Official title:

Evaluation of DCTclock™ as a Cognitive Assessment Aid

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03238001
• Other study ID #: DCT032
• Status: Completed
• Phase: N/A
• First received: July 27, 2017
• Last updated: March 5, 2018
• Start date: July 11, 2017
• Est. completion date: November 21, 2017

Study information

• Verified date: March 2018
• Source: Digital Cognition Technologies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 450
• Est. completion date: November 21, 2017
• Est. primary completion date: November 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Function

Intervention

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).

Locations

Country	Name	City	State
United States	Compass Research	Maitland	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Digital Cognition Technologies

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. Epub 2015 Oct 20. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	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
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.	Visit 1 (day 1)
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.	Visit 1 (day 1)
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.	Visit 1 (day 1)
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.	Visit 1 (day 1)
Secondary	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)
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).	Visit 1 and visit 2, occurring 1-4 weeks apart
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.	Visit 1 and visit 2, occurring 1-4 weeks apart
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.	Visit 1 and visit 2, occurring 1-4 weeks apart
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.	Visit 1 and visit 2, occurring 1-4 weeks apart