N/A
N=773
CAMCI: Advancing the Use of Computerized Screening in Healthcare
Cognitive Dysfunction · Cognitive Impairment · Cognitive Decline · Cognitive Change
Bottom Line
View on ClinicalTrials.gov: NCT03512301 ↗Enrolled (actual)
773
Serious AEs
0.8%
Results posted
Jun 2025
Primary outcome: Primary: Agreement Analysis (Agreement to Reference Standard) - Test Group — 76; 18; 2; 8 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- CAMCI (Device); MoCA (Diagnostic_test); Clinical Adjudication (Diagnostic_test)
- Age
- Adult, Older Adult · 60+ yrs
- Sex
- All
- Sponsor
- Psychology Software Tools, Inc.
- Primary completion
- May 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Agreement Analysis (Agreement to Reference Standard) - Test Group |
76; 18; 2; 8; 4; 1 | — |
| PRIMARY Agreement Analysis (Agreement to Non-Reference Standard) - Test Group |
54; 40; 2; 1; 12; 0 | — |
Summary
Cognitive impairment is a significant health problem in the United States, resulting in costs over $100 billion a year. We will provide an efficient, effective, and financially intelligent solution to Primary Care Physician's to identify cognitive impairment in the earliest stages, delay progression through appropriate treatment, and to afford patients the opportunity to make future plans at a time when symptoms are mild and patients are able to make informed decisions concerning financial and life activities. This has the potential to delay devastating effects of cognitive impairment, and to lessen the financial burden on the health care system in the United States.
Eligibility Criteria
Inclusion Criteria
- Signed informed consent
- Adequate visual and auditory acuity to allow neuropsychological testing
- Able to read, write and understand study and test requirements
- Within the age range of 60+
Exclusion Criteria
- Significant neurologic disease, such as multi-infarct dementia, Parkinson's disease, epilepsy, stroke, multiple sclerosis or head trauma
- History of major depression or other major psychiatric disorder, such as, schizophrenia and bipolar disorder
- History of consuming 5 or more alcoholic drinks per day on a regular basis
- Montreal Cognitive Assessment (MoCA) score <10
Data sourced from ClinicalTrials.gov (NCT03512301). 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.