CAMCI: Advancing the Use of Computerized Screening in Healthcare

NCT03512301 | Completed Results DMC FDA Device

• 2 other identifiers: 132SB1AG037357-04A1
• Study Type: interventional
• Target: 773
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Cognitive Dysfunction; Cognitive Impairment; Cognitive Decline; Cognitive Change

Outcome Measures

Primary Outcomes (2)

• 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

Other Outcomes (1)

• Change Metric (Measure of Significant Change)

  baseline, 6 months, 12 months, 24 months post baseline

Study Arms (1)

CAMCI Validation

EXPERIMENTAL

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; Diagnostic Test: MoCA; Diagnostic Test: Clinical Adjudication

Interventions

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.

Also known as: Computer Assessment of Memory and Cognitive Impairment

CAMCI Validation

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

Also known as: Montreal Cognitive Assessment

CAMCI Validation

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.

Also known as: Neuropsychological Tests

CAMCI Validation

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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+

You may not qualify if:

• 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

Sponsors & Collaborators

• Psychology Software Tools, Inc.: lead
• National Institute on Aging (NIA): collaborator

Study Sites (4)

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Psychology Software Tools

Sharpsburg, Pennsylvania, 15215, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Virginia

Charlottesville, Virginia, 22904, United States

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Limitations and Caveats

Baseline and Follow-Up assessment targets were not reached due to suspension of the trial during the COVID-19 pandemic. Sites prohibited in-person testing for a period of 6 months, resulting in withdrawal of subjects and loss of follow-up data according to the planned timeline. Additionally, after restart, the year 3 award restricted activities during the last 6 months of the project to analysis only, limiting testing duration. By design, the trial required 36 months to complete all follow-ups.

Results Point of Contact

• Title: Anthony Zuccolotto
• Organization: Psychology Software Tools, Inc.

anthony.zuccolotto@pstnet.com

412-449-0078

Study Officials

• Anthony Zuccolotto

  Psychology Software Tools

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Grants Administration Manager

Study Record Dates

• First Submitted: April 17, 2018
• First Posted: April 30, 2018
• Study Start: August 8, 2019
• Primary Completion: May 31, 2023
• Study Completion: May 31, 2023
• Last Updated: June 26, 2025
• Results First Posted: June 26, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ANALYTIC CODE
• 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.
• 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.

Locations

US (4)