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
1 other identifier
interventional
200
1 country
2
Brief Summary
Equivalence of DCTclock-pen and DCTclock-tablet will be tested in a randomized crossover trial.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2020
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 29, 2020
CompletedFirst Posted
Study publicly available on registry
August 3, 2020
CompletedStudy Start
First participant enrolled
December 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 16, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
November 16, 2021
CompletedResults Posted
Study results publicly available
March 7, 2025
CompletedMarch 7, 2025
March 1, 2025
11 months
July 29, 2020
December 12, 2023
March 4, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Number of Participants With Device-Related and Non-Device Related Adverse Events
5 weeks
Study Arms (2)
DCTclock-pen first
EXPERIMENTALDCTclock-pen followed by DCTclock-tablet
DCTclock-tablet first
EXPERIMENTALDCTclock-tablet followed by DCTclock-pen
Interventions
Eligibility Criteria
You may qualify if:
- years old
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Clincloud Research
Maitland, Florida, 32751, United States
Clinilabs
Eatontown, New Jersey, 07724, United States
Results Point of Contact
- Title
- Dr. Sean Tobyne
- Organization
- Linus Health
Study Officials
- STUDY CHAIR
Alvaro Pascual-Leone, MD
Linus Health
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 29, 2020
First Posted
August 3, 2020
Study Start
December 18, 2020
Primary Completion
November 16, 2021
Study Completion
November 16, 2021
Last Updated
March 7, 2025
Results First Posted
March 7, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share