Evaluation of DCTclock™ as a Cognitive Assessment Aid

NCT03238001 | Completed Results FDA Device

• 1 other identifier: DCT032
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Function

Keywords

Cognitive assessment; Cognition; Clock Test

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Quadratic Weighted Kappa on Primary Endpoints

  Visit 1 (day 1)

• Percent Agreement on Primary Endpoints

  Visit 1 (day 1)

• Regression Coefficients on Primary Endpoints

  Visit 1 (day 1)

• Correlation Coefficients on Primary Endpoints

  Visit 1 (day 1)

• Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)

  Visit 1 and visit 2, occurring 1-4 weeks apart

Other Outcomes (2)

• 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)

• Incidence of Serious Device-related Adverse Events [Safety]

  Visit 1 and visit 2, occuring 1-4 weeks apart

Study Arms (1)

All qualified participants

EXPERIMENTAL

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

Interventions

DCTclock DEVICE

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).

All qualified participants

Eligibility Criteria

• Age: 55 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women 55 to 95 years old.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Digital Cognition Technologies: lead

Study Sites (1)

Compass Research

Maitland, Florida, 32751, United States

Location

Related Publications (4)

• 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.

  PMID: 27037044 BACKGROUND

• 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.

  PMID: 27057085 BACKGROUND

• 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.

  PMID: 25222513 BACKGROUND

• 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.

  PMID: 27066307 BACKGROUND

Results Point of Contact

• Title: SVP, Clinical Affairs
• Organization: Digital Cognition Technologies

aholway@digitalcogtech.com

6174331777

Study Officials

• Antonia H Holway, Ph.D.

  Digital Cognition Technologies, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 3, 2017
• Study Start: July 11, 2017
• Primary Completion: November 21, 2017
• Study Completion: November 21, 2017
• Last Updated: April 3, 2018
• Results First Posted: April 3, 2018

Record last verified: 2018-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)