Evaluation of DCTclock™ as a Cognitive Assessment Aid

NCT ID: NCT03238001

Last Updated: 2018-04-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-11

Study Completion Date

2017-11-21

Brief Summary

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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.

Detailed Description

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Conditions

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Cognitive Function

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

DCTclock

Intervention Type 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).

Interventions

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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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Maximum Eligible Age

95 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Digital Cognition Technologies

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Antonia H Holway, Ph.D.

Role: STUDY_DIRECTOR

Digital Cognition Technologies, Inc.

Locations

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Compass Research

Maitland, Florida, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 27037044 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27057085 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25222513 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27066307 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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DCT032

Identifier Type: -

Identifier Source: org_study_id

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