Cognitive FunctionNCT04496752

Reliability and Equivalence of Alternate Forms of the Digital Clock Drawing Test

A study testing DCTclock in people with Cognitive Function, run by Linus Health, Inc. at 2 sites in United States.

Completed

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

Trial summary

Equivalence of DCTclock-pen and DCTclock-tablet will be tested in a randomized crossover trial. 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: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 200 participants
Where: 2 sitesUnited States
Study dates: 18 Dec 2020to 16 Nov 2021
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

55-95 years old

Who cannot join

Ineligible for written informed consent
Impairment of the writing hand that precludes ability to perform the study tasks
Impaired manual dexterity in the writing hand
Impaired vision in both eyes
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 (within the last 6 months) cognitive testing with a Clock Drawing Test.
Visit 2 Only- Self-reported change (addition or discontinuation) of the following medications between visit 1 and visit 2; Timolol (eye drop), Benadryl, beta blockers, steroids or over the counter medications for sleep (PM varieties).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Clinilabs
Eatontown, New Jersey, 07724
Clincloud Research
Maitland, Florida, 32751

Other trials in United States

About this study

Official title: A Randomized Crossover Study to Assess the Reliability and Equivalence of Alternate Forms of the Digital Clock Drawing Test

Equivalence of DCTclock-pen and DCTclock-tablet will be tested in a randomized crossover trial.

Read the detailed description

Randomized crossover trial consisting of two test visits separated by a washout period of 3 to 5 weeks. Subjects are randomized into two equal groups. Group 1 receives the digital pen (DCTclock-pen) version of the test at the first visit, with the tablet version (DCTclock-tablet) given at the second visit; Group 2 receives DCTclock-tablet at the first visit, followed by DCTclock-pen at the second visit. At Visit 1 (day 0), eligibility is assessed and a version of the DCTclock test is administered based on the group allocation. A battery of Linus Platform tests and reference standard tests are also administered. At visit 2 (day 21-35), eligibility is assessed and the alternate version of the DCTclock test is administered based on the group allocation. A battery of Linus Platform tests is also administered, together with reference standard tests. Equivalence of DCTclock-pen and DCTclock-tablet will be tested. Linus Platform test data will also be collected to develop novel measures of cognitive and motor function and assess their accuracy in detecting impairment, construct validity, and test-retest reliability.

Conditions: Cognitive Function
Being tested: DCTclock

What participants receive

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

DCTclockDevice
Cognitive Test

Study groups in NCT04496752
Study group	Role	What they receive
DCTclock-pen first	Experimental	DCTclock-pen followed by DCTclock-tablet Receives: Device: DCTclock
DCTclock-tablet first	Experimental	DCTclock-tablet followed by DCTclock-pen Receives: Device: DCTclock

What is being measured

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

Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment
Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of agreement with MMSE.
Measured: 5 weeks
Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation)
Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of correlation with MMSE.
Measured: 5 weeks

Secondary outcomes (1)

Number of Participants With Device-Related and Non-Device Related Adverse Events
Number of serious device-related adverse events. See adverse events section for full reporting of adverse events, including both device-related and non-device related.
Measured: 5 weeks

Timeline

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

18 Dec 202016 Nov 2021

First posted3 Aug 2020
Study start18 Dec 2020
Primary completion16 Nov 2021
Study completion16 Nov 2021

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.
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: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 200 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04496752
Sponsor's protocol ID: DCT216
Status last verified: Mar 2025
First submitted: 29 Jul 2020
Last updated: 7 Mar 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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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Study at a glance

From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized Crossover Study to Assess the Reliability and Equivalence of Alternate Forms of the Digital Clock Drawing Test
ClinicalTrials.gov ID: NCT04496752
Acronym / sponsor ID: DCT216
Conditions: Cognitive Function
Study type: Interventional
Recruitment status: Completed
Enrolment: 200 participants (actual)
Lead sponsor: Linus Health, Inc.Industry (pharma, biotech, devices)
Study start: 18 Dec 2020 (actual)
Primary completion: 16 Nov 2021 (actual)
Study completion: 16 Nov 2021 (actual)
First posted: 3 Aug 2020 (actual)
Results: Posted 7 Mar 2025

Clinical summary

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

Equivalence of DCTclock-pen and DCTclock-tablet will be tested in a randomized crossover trial.

Detailed description

Study design

Primary purpose: Screening
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
DCTclock-pen first	Experimental	Device: DCTclockDCTclock-pen followed by DCTclock-tablet
DCTclock-tablet first	Experimental	Device: DCTclockDCTclock-tablet followed by DCTclock-pen

Who may qualify

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

Key inclusion criteria (1 listed)

55-95 years old

Key exclusion criteria (8 listed)

Ineligible for written informed consent
Impairment of the writing hand that precludes ability to perform the study tasks
Impaired manual dexterity in the writing hand
Impaired vision in both eyes
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
DCTclockCognitive Test	Device	DCTclock-pen first, DCTclock-tablet first

Primary outcome

Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment
Time frame: 5 weeks
Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of agreement with MMSE.
Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation)
Time frame: 5 weeks
Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of correlation with MMSE.

1 secondary outcome

Number of Participants With Device-Related and Non-Device Related Adverse Events
Time frame: 5 weeks

Results and safety

Results posted to the registry on 7 Mar 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
DCTclock-pen First	97	97
DCTclock-tablet First	98	98

Primary outcome: Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment

Time frame: 5 weeks. Number (90% Confidence Interval). Unit: Cohen's Kappa Coefficient

Measure	DCTClock-pen n = 170	DCTClock-tablet n = 170
Value	0.16 (0.05 to 0.27)	0.23 (0.12 to 0.33)

DCTClock-pen vs DCTClock-tablet: Difference in Cohen's Kappa: 0.07 (90% CI -0.05 to 0.19)

Population analysed: Analysis includes only assessments from participants who: (1) completed both assessment sessions; and (2) produced clocks from both assessments which could be analyzed to give a valid score. Of participants who completed both sessions, 170 of 187 produced two analyzable clocks and were included in analysis (84 of 92 in the pen-first group, and 86 of 95 in the tablet-first group).

Primary outcome: Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation)

Time frame: 5 weeks. Number (90% Confidence Interval). Unit: correlation coefficient

Measure	DCTClock-pen n = 170	DCTClock-tablet n = 170
Pearson Correlation	0.31 (0.17 to 0.43)	0.37 (0.25 to 0.49)
Spearman Correlation	0.29 (0.17 to 0.41)	0.36 (0.24 to 0.46)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected from the start of the first study visit to the end of the second and last visit (3-5 weeks subsequent).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
DCTclock-pen First, DCTclock-pen Visit	0 of 97 (0%)	0 of 97 (0%)	0 of 97
DCTclock-tablet First, DCTclock-tablet Visit	0 of 98 (0%)	0 of 98 (0%)	0 of 98
DCTclock-pen First, DCTclock-tablet Visit	0 of 97 (0%)	0 of 97 (0%)	0 of 97
DCTclock-tablet First, DCTclock-pen Visit	0 of 98 (0%)	1 of 98 (1%)	0 of 98
DCTclock-pen First, Between Visits	3 of 97 (3.1%)	4 of 97 (4.1%)	1 of 97
DCTclock-tablet First, Between Visits	0 of 98 (0%)	1 of 98 (1%)	0 of 98

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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.

Alvaro Pascual-Leone, MD study chair

Linus Health

2 sites 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 Linus Health, Inc. at 2 sites 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 8 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 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 7 Mar 2025). 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?

Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (time frame: 5 weeks). The study lists 2 primary outcomes in all. 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 NCT04496752.

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 7 Mar 2025.