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

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.

Study Overview

• Status: Completed
• Conditions: Cognitive Function
• Intervention / Treatment: Device: DCTclock

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.

• Study Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Maitland, Florida, United States, 32751
      • ClinCloud Research
  • New Jersey
    • Eatontown, New Jersey, United States, 07724
      • Clinilabs

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DCTclock-pen first; DCTclock-pen followed by DCTclock-tablet	Device: DCTclock; Cognitive Test
Experimental: DCTclock-tablet first; DCTclock-tablet followed by DCTclock-pen	Device: DCTclock; Cognitive Test

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	5 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 weeks

Collaborators and Investigators

• Sponsor: Linus Health, Inc.
• Investigators: Study Chair: Alvaro Pascual-Leone, MD, Linus Health

Study record dates

Study Major Dates

• Study Start (Actual): December 18, 2020
• Primary Completion (Actual): November 16, 2021
• Study Completion (Actual): November 16, 2021

Study Registration Dates

• First Submitted: July 29, 2020
• First Submitted That Met QC Criteria: July 29, 2020
• First Posted (Actual): August 3, 2020

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: DCT216

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No