Cognitive FunctionNCT03238001

Evaluation of DCTclock™ as a Cognitive Assessment Aid

A study testing DCTclock in people with Cognitive Function, run by Digital Cognition Technologies at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 55 to 95 yearsHealthy volunteers can take part
Conditions the study is for: Cognitive Function
What is being tested?: DCTclock
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 450 participants
Where: 1 siteUnited States
Study dates: 11 Jul 2017to 21 Nov 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 55 to 95 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Men and women 55 to 95 years old.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Compass Research
Maitland, Florida, 32751

Other trials in United States

About this study

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
Being tested: DCTclock
Keywords: Cognitive assessment, Cognition, Clock Test

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DCTclockDevice
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).

Study groups in NCT03238001
Study group	Role	What they receive
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. Receives: Device: DCTclock

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Visit 1 (day 1)

Secondary outcomes (8)

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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Visit 1 and visit 2, occurring 1-4 weeks apart

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

11 Jul 201721 Nov 2017

First posted3 Aug 2017
Study start11 Jul 2017
Primary completion21 Nov 2017
Study completion21 Nov 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for Cognitive FunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
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.
Masking: None (open label)
Enrolment: 450 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03238001
Sponsor's protocol ID: DCT032
Status last verified: Mar 2018
First submitted: 27 Jul 2017
Last updated: 3 Apr 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No: We do not plan to share IPD

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.
PubMed 27037044
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.
PubMed 27057085
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.
PubMed 25222513
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.
PubMed 27066307

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cognitive Function trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of DCTclock™ as a Cognitive Assessment Aid
ClinicalTrials.gov ID: NCT03238001
Acronym / sponsor ID: DCT032
Conditions: Cognitive Function
Keywords: Cognitive assessment, Cognition, Clock Test
Study type: Interventional
Recruitment status: Completed
Enrolment: 450 participants (actual)
Lead sponsor: Digital Cognition TechnologiesIndustry (pharma, biotech, devices)
Study start: 11 Jul 2017 (actual)
Primary completion: 21 Nov 2017 (actual)
Study completion: 21 Nov 2017 (actual)
First posted: 3 Aug 2017 (actual)
Results: Posted 3 Apr 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
All qualified participants	Experimental	Device: DCTclockParticipants received DCTclock, Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and a battery of other traditional pen and paper neuropsychological assessments.

Who may qualify

Ages: 55 to 95 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Men and women 55 to 95 years old.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
DCTclockDCTclock 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).	Device	All qualified participants

Primary outcome

Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)
Time frame: Visit 1 (day 1)
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.

8 secondary outcomes

Quadratic Weighted Kappa on Primary Endpoints
Time frame: Visit 1 (day 1)
Percent Agreement on Primary Endpoints
Time frame: Visit 1 (day 1)
Regression Coefficients on Primary Endpoints
Time frame: Visit 1 (day 1)
Correlation Coefficients on Primary Endpoints
Time frame: Visit 1 (day 1)
Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability)
Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
Percent Agreement on Secondary Endpoints (Test-retest Reliability)
Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
Regression Coefficients on Secondary Endpoints (Test-retest Reliability)
Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart
Correlation Coefficients on Secondary Endpoints (Test-retest Reliability)
Time frame: Visit 1 and visit 2, occurring 1-4 weeks apart

Results and safety

Results posted to the registry on 3 Apr 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
All Qualified Participants	436	432

Primary outcome: Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE)

Time frame: Visit 1 (day 1). Number (90% Confidence Interval). Unit: Difference in Quadratic Weighted Kappas

Measure	Primary Endpoint (Evaluable) Population n = 432
Value	-0.035 (-0.12 to 0.05)

Primary Endpoint (Evaluable) Population: Lower 90% CL for difference in Kappas: -0.12 (90% CI -0.12 to 0.05)

Population analysed: The Evaluable Population includes all qualified participants undergoing cognitive testing with DCTclock, MMSE, and MoCA who completed visit 1.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data was collected at each study visit. The second (final) study visit occurred one to four weeks after the first visit, therefore, adverse event data was collected for a period of one to four weeks.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Participants	1 of 436 (0.2%)	0 of 436 (0%)	0 of 436

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 27037044Lamar 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.
Background: PubMed 27057085Souillard-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.
Background: PubMed 25222513Cohen 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.
Background: PubMed 27066307Davis 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.
Individual participant dataSharing planned: No. We do not plan to share IPD

Related trials for Cognitive Function

Enrolling by invitationPhase 2
Tau PET Outcomes With Anti-amyloid Immunotherapies
Cognitive Impairment, Mild, Dementia, Mild
Active, not recruiting
Primary Care Detection of Cognitive Impairment Leveraging Health & Consumer Technologies in Underserved Communities: The MyCog Trial
Dementia, Cognitive Impairment
Not yet recruitingObservational study
Ecological Momentary Assessment of State-Dependent Decision-Making and Metacognition Across a Psychopathology Continuum
Depression, Anxiety
Not yet recruitingObservational study
Correlation Between Forward Head Posture and Executive Functions in Cervical Radiculopathy
Cervical Radiculopathy, Forward Head Posture
RecruitingPhase 1
PET Imaging of Phosphodiesterase-4 (PDE4) in Volunteers With Alzheimer Disease (AD) or Mild Cognitive Impairment (MCI)
Alzheimer s Disease, Mild Cognitive Impairment

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Antonia H Holway, Ph.D. study director

Digital Cognition Technologies, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing DCTclock in people with Cognitive Function, run by Digital Cognition Technologies at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Apr 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE) (time frame: Visit 1 (day 1)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03238001, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.