N/A
Completed N=195
Reliability and Equivalence of Alternate Forms of the Digital Clock Drawing Test
Cognitive Function
Source: ClinicalTrials.gov NCT04496752 ↗
Enrolled (actual)
195
Serious AEs
0.5%
Results posted
Mar 2025
Primary outcomePrimary: Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment — 0.16; 0.23 Cohen's Kappa Coefficient
Summary
Equivalence of DCTclock-pen and DCTclock-tablet will be tested in a randomized crossover trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment |
0.16; 0.23 | — |
| PRIMARY Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment (Correlation) |
0.31; 0.37; 0.29; 0.36 | — |
| SECONDARY Number of Participants With Device-Related and Non-Device Related Adverse Events |
0; 0; 0; 0; 97; 98 | — |
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT04496752). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.