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

Not Applicable

Completed

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

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.

Recruitment & Eligibility

Inclusion Criteria

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).

Primary Outcome Measures

Name	Time	Method
Equivalence of DCTclock-pen and DCTclock-tablet in Assessing Cognitive Impairment	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)	5 weeks	Equivalence of DCTclock-pen and DCTclock-tablet in assessing cognitive impairment, as measured by comparison of correlation with MMSE.

Secondary Outcome Measures

Name	Time	Method
Number of Participants With Device-Related and Non-Device Related Adverse Events	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.