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.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment; Cognitive Dysfunction; Cognitive Change; Cognitive Decline
• Intervention / Treatment: Device: CAMCI; Diagnostic test: MoCA; Diagnostic test: Clinical Adjudication

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 773
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University
  • Pennsylvania
    • Sharpsburg, Pennsylvania, United States, 15215
      • Psychology Software Tools
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
  • Virginia
    • Charlottesville, Virginia, United States, 22904
      • University of Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 56 years to 91 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CAMCI Validation; Completion of computerized tasks (Computer Assessment of Memory and Cognitive Impairment) and traditional neuropsychological tests administered via paper-pencil method by a trained administrator

Device: CAMCI; 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; Diagnostic test: MoCA; 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; Diagnostic test: Clinical Adjudication; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Agreement Analysis (Agreement to Reference Standard) - Test Group	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.	baseline
Agreement Analysis (Agreement to Non-Reference Standard) - Test Group	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.	baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Criterion validity correlation analysis	Analysis of correlations between CAMCI accuracy measures (i.e., accuracy of responses within individual tasks) and individual paper and pencil neuropsychological tests (i.e., scores achieved on individual tests) to assess both convergent (high correlations with related measures) and divergent (lower correlations with measures that should not be related) validity.	baseline
Test/retest reliability	Repeatability of CAMCI	2-3 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change Metric (Measure of Significant Change)	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.	baseline, 6 months, 12 months, 24 months post baseline

Collaborators and Investigators

• Sponsor: Psychology Software Tools, Inc.
• Collaborators: National Institute on Aging (NIA)
• Investigators: Study Director: Anthony Zuccolotto, Psychology Software Tools

Study record dates

Study Major Dates

• Study Start (Actual): August 8, 2019
• Primary Completion (Actual): May 31, 2023
• Study Completion (Actual): May 31, 2023

Study Registration Dates

• First Submitted: April 17, 2018
• First Submitted That Met QC Criteria: April 27, 2018
• First Posted (Actual): April 30, 2018

Study Record Updates

• Last Update Posted (Actual): June 26, 2025
• Last Update Submitted That Met QC Criteria: June 24, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 13; 2SB1AG037357-04A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

Quality-controlled raw data as well as processed data used in publications will be made available. Shared data will include computerized task scores, neuropsychological test scores, and full analytical codes used to process and analyze the data. Workflows will be described and documented to allow replication of results from the raw data.

Data and corresponding documentation will be made available through Open Science Framework, in addition to any potential requirements on software sharing by journals.

The PI or Co-Investigators will disseminate results from this research through presentations at public lectures, scientific institutions and meetings, and/or publication in major journals. The PI and Co-Investigators will adhere to the NIH Grants Policy on Sharing of Unique Research Resources including the Sharing of Biomedical Research Resources: Guidelines for Recipients of NIH Grants and Contracts on Obtaining and Disseminating Biomedical Research Resources.

IPD Sharing Time Frame

Data will be deposited into the repository indicated above as soon as possible, but no later than 4 years after the end of the award project period.

The Small Business Act provides authority for NIH to protect from disclosure and nongovernmental use all Small Business Innovative Research (SBIR) data developed from work performed under an SBIR funding agreement for a period of 4 years after the closeout of either a phase I or phase II grant unless NIH obtains permission from the awardee to disclose these data. The data rights protection period lapses only upon expiration of the protection period applicable to the SBIR award, or by agreement between the small business concern and NIH.

• IPD Sharing Access Criteria: PST will identify where the data will be available and how to access the data in any publications and presentations about these data, as well as acknowledge the repository and funding source in any publications and presentations. In addition, PST will abide by the policies and procedures required by the repository indicated above, fully consistent with NIH data sharing policies and applicable laws and regulations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No