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Completed

NCT Number: NCT04496752

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.

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Key information

Conditions

Age range

55 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clincloud Research, Maitland, Florida, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 55-95 years old

Exclusion criteria

  • 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).

Treatment and study plan

DCTclock

Device

Cognitive Test

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Number of Participants With Device-Related and Non-Device Related Adverse Events

    Time frame: 5 weeks

    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.

Sponsors and collaborators

Lead sponsor

Linus Health, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Aug 3, 2020
Registry last updated
Mar 7, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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