Evaluation of DCTclock™ as a Cognitive Assessment Aid
- Conditions
- Cognitive Function
- Interventions
- Device: DCTclock
- Registration Number
- NCT03238001
- Lead Sponsor
- Digital Cognition Technologies
- Brief Summary
The overall objective of this study is to demonstrate the safety and effectiveness of DCTclock as an adjunctive tool for use by clinicians to evaluate cognitive function in adults aged 55-95.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 450
- Men and women 55 to 95 years old.
- Ineligible for written informed consent.
- Physical impairment of the writing hand.
- Impaired manual dexterity.
- Impaired vision.
- 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 cognitive testing.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description All qualified participants DCTclock Participants received DCTclock, Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA), and a battery of other traditional pen and paper neuropsychological assessments.
- Primary Outcome Measures
Name Time Method Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE) Visit 1 (day 1) The primary analysis will assess agreement between DCTclock and the Montreal Cognitive Assessment (MoCA) and compare it to the agreement between the MMSE and MoCA at visit 1.
- Secondary Outcome Measures
Name Time Method Regression Coefficients on Primary Endpoints Visit 1 (day 1) Linear and rank-linear regression coefficients (slope, intercept) and 95% CI for DCTclock regressed on MoCA as well as for the MMSE regressed on MoCA.
Percent Agreement on Secondary Endpoints (Test-retest Reliability) Visit 1 and visit 2, occurring 1-4 weeks apart Positive percent agreement version A (treating the "Indeterminate" group as "Unimpaired") and version B (removing the "Indeterminate" group from the analysis), negative percent agreement version A and version B, indeterminate percent agreement, and unimpaired percent agreement.
Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability) Visit 1 and visit 2, occurring 1-4 weeks apart Quadratic weighted Cohen's Kappa statistics were calculated for both DCTclock and MMSE test-retest data (visit 1 vs visit 2).
Correlation Coefficients on Primary Endpoints Visit 1 (day 1) Pearson and Spearman correlation coefficients between DCTclock and MoCA as well as between MMSE and MoCA.
Quadratic Weighted Kappa on Primary Endpoints Visit 1 (day 1) Quadratic weighted Cohen's kappa with 95% CI between DCTclock and MoCA, as well as between MMSE and MoCA.
Percent Agreement on Primary Endpoints Visit 1 (day 1) Positive percent agreement, version A (treating the "Indeterminate" group as "Unimpaired") and version B (removing the "Indeterminate" group from the analysis), and negative percent agreement version A and version B. These were calculated for the DCTclock/MoCA classification table as well as the MMSE/MoCA classification table. 95% CI were also calculated and compared between the two classification tables' calculations.
Regression Coefficients on Secondary Endpoints (Test-retest Reliability) Visit 1 and visit 2, occurring 1-4 weeks apart Deming, linear, and rank-linear correlation coefficients (intercept, slope) were calculated for visit 1 regressed on visit 2 for both DCTclock and MMSE.
Correlation Coefficients on Secondary Endpoints (Test-retest Reliability) Visit 1 and visit 2, occurring 1-4 weeks apart Pearson and Spearman correlation coefficients were calculated between visit 1 and visit 2 for DCTclock and MMSE, along with 95% CI.
Trial Locations
- Locations (1)
Compass Research
🇺🇸Maitland, Florida, United States