CAMCI: Advancing the Use of Computerized Screening in Healthcare

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

Interventions

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.

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

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.

Sponsors & Collaborators

• National Institute on Aging (NIA)

  collaborator NIH

• Psychology Software Tools, Inc.

  lead INDUSTRY

Principal Investigators

• Anthony Zuccolotto · Psychology Software Tools

Study Design

Allocation

NA

Purpose

SCREENING

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

60 Years

Max Age

95 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-08-08

Primary Completion

2023-05-31

Completion

2023-05-31

FDA Device

Yes

Countries

• United States

Study Locations