N/A
N=436
Evaluation of DCTclock™ as a Cognitive Assessment Aid
Cognitive Function
Bottom Line
View on ClinicalTrials.gov: NCT03238001 ↗Enrolled (actual)
436
Serious AEs
0.2%
Results posted
Apr 2018
Primary outcome: Primary: Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE) — -0.035 Difference in Quadratic Weighted Kappas
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- DCTclock (Device)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- Digital Cognition Technologies
- Primary completion
- Nov 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-Inferiority of DCTclock Compared to Mini-Mental State Examination (MMSE) |
-0.035 | — |
| SECONDARY Quadratic Weighted Kappa on Primary Endpoints |
0.40; 0.44 | — |
| SECONDARY Percent Agreement on Primary Endpoints |
0.64; 0.56; 0.78; 0.69; 0.74; 0.83 | — |
| SECONDARY Regression Coefficients on Primary Endpoints |
19.35; -5.03; 0.07; 1.03; 107.75; 96.45 | — |
| SECONDARY Correlation Coefficients on Primary Endpoints |
0.53; 0.59; 0.50; 0.55 | — |
| SECONDARY Quadratic Weighted Kappa on Secondary Endpoints (Test-Retest Reliability) |
0.53; 0.48 | — |
| SECONDARY Percent Agreement on Secondary Endpoints (Test-retest Reliability) |
0.73; 0.74; 0.85; 0.84; 0.76; 0.80 | — |
| SECONDARY Regression Coefficients on Secondary Endpoints (Test-retest Reliability) |
8.77; 2.96; 0.93; 0.91; 25.03; 10.88 | — |
| SECONDARY Correlation Coefficients on Secondary Endpoints (Test-retest Reliability) |
0.70; 0.67; 0.67; 0.56 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Men and women 55 to 95 years old.
Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT03238001). 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.