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Completed

NCT Number: NCT03512301

CAMCI: Advancing the Use of Computerized Screening in Healthcare

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.

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Key information

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Indiana University, Indianapolis, Indiana, United States

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About this study

Cognitive dysfunction in the elderly population, ranging from simple forgetfulness to a diagnosis of Alzheimer's disease, can impact one's quality of life and ability to function in daily activities. It is crucial that decline be detected as early as possible in order to evaluate whether the cause is treatable, and to employ appropriate treatment, if applicable. The majority of older patients rely on their primary care physician for the bulk of their healthcare needs, but there is a lack of sensitive tools available, and there is a lack of physician's time to use the tools, leading to a failure to provide therapeutic intervention at the earliest stages of loss to potentially slow the progression of disease. Psychology Software Tools, Inc. (PST) has developed the Computer Assessment of Memory and Cognitive Impairment (CAMCI), a computerized screening tool for detection of early signs of cognitive decline, which has been shown to be more effective in the identification of patients with subtle cognitive loss than the tools most frequently used within the primary care physician (PCP) office. CAMCI would provide an option for PCPs and clinicians to provide therapeutic intervention prior to a diagnosis of dementia. Recent additions to Current Procedural Terminology (CPT) codes permit insurance reimbursement for neuropsychological testing by a computer, including time for the physician's or clinical psychologist's interpretation and reporting. The introduction of this new revenue stream for PCPs and clinicians, coupled with the characteristics of being brief and self-administered make CAMCI an attractive option for improving early intervention, providing an intelligent business solution for healthcare professionals, and a useful and effective tool that allows physicians to better evaluate and serve their patients. The specific aims included in the current project focus on activities required to successfully move CAMCI to commercialization by extending support for late stage research and product development, including regulatory strategy and intellectual property development, data collection to replicate key studies, product extension through increasing minority representation, and development of a measure of meaningful change. The ultimate goal is to streamline commercialization of CAMCI, and to provide a useful and effective tool in the detection of cognitive dysfunction to physicians, the providers of the majority of healthcare to the elderly population, to improve efficiency and effectiveness of clinical practice.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CAMCI

Device

CAMCI is a computerized screening tool for the assessment of cognitive status. CAMCI accurately assesses cognitive performance using standard neuropsychological tests of memory, attention, and executive ability modified for computer administration, and an innovative Virtual Environment task, testing domains such as incidental memory, not easily assessed using paper-pencil tests. Computer-administered tasks ensure standard administration and scoring, avoiding inter-site and inter-examiner variability. The CAMCI battery consists of tasks testing multiple aspects of cognitive function, and a series of self-report questions administered via tablet computer. Using touchscreen technology for response input, CAMCI takes approximately 15-20 minutes to complete.

Other names: Computer Assessment of Memory and Cognitive Impairment

MoCA

Diagnostic Test

The Montreal Cognitive Assessment (MoCA) is a rapid screening tool used to detect mild cognitive impairment (MCI), assessing cognitive domains (visuospatial skills, executive function, memory, attention, language, and orientation). Individual test scores are summed into a total score from 0 (worst) to 30 (best). Individuals may achieve any score within that range. Individual test scores are not reported.

Scores:

26-30 considered Normal; 19-25 may suggest Mild Cognitive Impairment (MCI); 10-18 can suggest moderate impairment; < 10 may indicate severe impairment

Other names: Montreal Cognitive Assessment

Clinical Adjudication

Diagnostic Test

Cognitive status assessed by traditional neuropsychological tests measuring visuospatial skills, executive function, memory, attention, language, orientation. Results compared to age-adjusted norms, reviewed by expert neuropsychologists for consensus classification, per Univ of Pittsburgh Alzheimers Disease Research Ctr and Ntl Alzheimers Coordinating Ctr, and Alzheimer's Assoc criteria. Final classification adjusted per clinical judgment.

Impaired: ≥3 scores ≥2SD below norms Indeterminate: ≤2 scores >1SD below norms Normal: Neither criteria met. Total and domain scores not reported.

Other names: Neuropsychological Tests

Primary outcomes

  1. Agreement Analysis (Agreement to Reference Standard) - Test Group

    Time frame: baseline

    Comparison (positive and negative percent agreement, confidence interval estimates, and quadratic weighted kappa) between CAMCI and clinical adjudication classifications for the Test group. Power calculations for agreement were assessed for Cohen Kappa's assuming at least 75% Normals with 80% power and .05 significance level, finding that we were sufficiently powered with at least 120 individuals in the test set, for a Kappa of at least 0.3.

  2. Agreement Analysis (Agreement to Non-Reference Standard) - Test Group

    Time frame: baseline

    Linear regression agreement analysis (linear regression equation and confidence intervals, and Pearson correlation) between CAMCI and Montreal Cognitive Assessment (MoCA) for the Test group. Comparison (positive and negative percent agreement, confidence interval estimates, and quadratic weighted kappa) between CAMCI and Montreal Cognitive Assessment (MoCA) for the Test group.

    CAMCI Scores ranged from 0-50, higher scores mean better outcome. MoCA scores ranged from 0-30, higher scores mean better outcome.

    Power calculations for agreement were assessed for Cohen Kappa's assuming at least 75% Normals with 80% power and .05 significance level, finding that we were sufficiently powered with at least 120 individuals in the test set, for a Kappa of at least 0.3.

Other outcomes

  1. Change Metric (Measure of Significant Change)

    Time frame: baseline, 6 months, 12 months, 24 months post baseline

    To derive a measure of reliable change that addressed unbalanced repeated measures and unequal timing of repeat measures, we built a two-stage hierarchical model for longitudinal data using Bayesian methods. Additionally, the standard deviation (SD) was allowed to change over time, which allowed for computation of an intraclass correlation coefficient (ICC), a measure of reliability. With an SD and ICC that can change over time, reliable change was computed for follow-up months from 3 to 24, in groups of 3. Reliable change was then adjusted for practice effects according to Duff, K. (2012).

    Computer Assessment of Memory and Cognitive Impairment (CAMCI) scores were calculated as the weighted sum of individual task scores converted to a total score from 0-worst to 50-best. As the intended use of CAMCI is to provide a single score of overall cognitive status, individual task scores were not reported.

Sponsors and collaborators

Lead sponsor

Psychology Software Tools, Inc.

Industry

Collaborators

  • National Institute on Aging (NIA)

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 30, 2018
Registry last updated
Jun 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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