CAMCI: Advancing the Use of Computerized Screening in Healthcare

NCT ID: NCT03512301

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 773 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-08
• Study Completion Date: 2023-05-31

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.

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.

Conditions

Cognitive Dysfunction; Cognitive Impairment; Cognitive Decline; Cognitive Change

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CAMCI

Intervention Type: 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.

MoCA

Intervention Type: 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

Clinical Adjudication

Intervention Type: 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.

Interventions

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.

Intervention Type: DEVICE

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

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Computer Assessment of Memory and Cognitive Impairment; Montreal Cognitive Assessment; Neuropsychological Tests

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute on Aging (NIA)

NIH

Sponsor Role: collaborator

Psychology Software Tools, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Amy Eschman

Grants Administration Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anthony Zuccolotto

Role: STUDY_DIRECTOR

Psychology Software Tools

Locations

Indiana University

Indianapolis, Indiana, United States

Psychology Software Tools

Sharpsburg, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

University of Virginia

Charlottesville, Virginia, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2SB1AG037357-04A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

13

Identifier Type: -

Identifier Source: org_study_id