Clinical trial NCT03238001: Evaluation of DCTclock™ as a Cognitive Assessment Aid
Official title: Evaluation of DCTclock™ as a Cognitive Assessment Aid
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Function
Keywords: Cognitive assessment
Cognition
Clock Test
Lead sponsor: Digital Cognition Technologies
Sponsor class: INDUSTRY
First posted: 2017-08-03
Enrollment: 450
Sex: ALL
Minimum age (years): 55
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: SCREENING

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)
timeFrame: Visit 1 (day 1)
Secondary outcomes:
measure: Quadratic Weighted Kappa on Primary Endpoints
timeFrame: Visit 1 (day 1)
measure: Percent Agreement on Primary Endpoints
timeFrame: Visit 1 (day 1)
measure: Regression Coefficients on Primary Endpoints
timeFrame: Visit 1 (day 1)
measure: Correlation Coefficients on Primary Endpoints
timeFrame: Visit 1 (day 1)
measure: Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)
timeFrame: Visit 1 and visit 2, occurring 1-4 weeks apart
measure: Percent Agreement on Secondary Endpoints (Test-retest Reliability)
timeFrame: Visit 1 and visit 2, occurring 1-4 weeks apart
measure: Regression Coefficients on Secondary Endpoints (Test-retest Reliability)
timeFrame: Visit 1 and visit 2, occurring 1-4 weeks apart
measure: Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)
timeFrame: Visit 1 and visit 2, occurring 1-4 weeks apart
Other outcomes:
measure: Construct Validity of DCTclock as Measured by the Comparison of DCTclock Results to the Results of a Battery of Neuropsychological Assessments
timeFrame: Visit 1 (day 1)
measure: Incidence of Serious Device-related Adverse Events [Safety]
timeFrame: Visit 1 and visit 2, occuring 1-4 weeks apart
Locations:
city: Maitland
country: United States
facility: Compass Research
state: Florida
Study officials:
affiliation: Digital Cognition Technologies, Inc.
name: Antonia H Holway, Ph.D.
role: STUDY_DIRECTOR
References:
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.
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. doi: 10.1007/s10994-015-5529-5. Epub 2015 Oct 20.
citation: 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.
citation: 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.