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

Linus Health, Inc.200 enrolled

Overview

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

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

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

NONE

Enrollment

200

Conditions

Cognitive Function

Interventions

DCTclockDEVICE

Cognitive Test

Eligibility

Sex: ALLMin age: 55 YearsMax age: 95 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (2)

Clincloud Research

Maitland, Florida, United States

Clinilabs

Eatontown, New Jersey, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 5 weeks

Secondary Outcomes

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.

Time frame: 5 weeks

Data from ClinicalTrials.gov

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