Pilot Testing a New Computer-based Screening Tool to Detect Cognitive Impairment

A computer-based neuropsychological assessment tool is being developed to help primary care physicians detect neurological and psychiatric disorders. The first version will be tested against current tests to confirm the tool's effectiveness. Data will be collected on how well the tool detects disease, how well patients understand the instructions and enjoy performing the tasks, and if particular trials or stimuli are too difficult or too easy for all subjects. Adjustments can then be made to the assessment tool, if needed. The initial participants will be age fifty-five to seventy-five with early dementias or mild cognitive impairment to reduce variability.

Study Overview

• Status: Completed
• Conditions: Cognitive Impairment
• Intervention / Treatment: Other: cognitive testing

Detailed Description

The investigators are developing a computer-based neuropsychological assessment tool to help primary care physicians detect neurological and psychiatric disorders. To confirm the tool's efficacy, the investigators will first test the prototype against established tests. The investigators propose to collect preliminary data on a limited group of subjects and age-matched controls. Collecting data on a limited group of subjects provides early insight into how well the tool detects disease, how well patients understand the instructions and enjoy performing the tasks, and if particular trials or stimuli are too difficult or too easy for all subjects. With this information, the investigators can make adjustments to the tool if needed and collect additional data on revised versions of the tool. The data will be used to establish the validity, reliability and sensitivity of the tool to generate consistent and accurate scores. The investigators will initially focus on a limited age range (age fifty-five to seventy-five) and limited set of diseases (early dementias or mild cognitive impairment) to reduce variability within the patient and control groups and to gain more statistical power with a smaller group of subjects.

• Study Type: Observational
• Enrollment (Actual): 152

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Unversity of Nebraska Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Community-dwelling adults without significant cognitive impairment

Description

Inclusion Criteria:

• Any subject with mild impairment from who has already undergone or will soon undergo a full neuropsychological evaluation.
• Subjects with Clinical Dementia Rating Scale CDR of 0.5-1.0 and Mini-Mental Score 20-26 (or MOCA equivalent, borderline/mild dementia) will be eligible for this group.
• Normal controls without exclusion criteria.

Exclusion Criteria:

• Subjects whose impairment is severe enough to limit their ability to perform the computer-based tasks and/or to provide consent.
• Subjects with history of learning disabilities or mental illness including major depression, bipolar disorder, anxiety disorders, and addiction are excluded because these problems can affect cognitive performance.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
community dwelling older adults, normal controls; men and women 55 years of age or older who are cognitively intact.	Other: cognitive testing; computer-based cognitive assessment
community dwelling older adults, mild cognitive impairment; men and women 55 years of age or older who have minimal cognitive decline (MMSE 20-24).	Other: cognitive testing; computer-based cognitive assessment

Collaborators and Investigators

• Sponsor: University of Nebraska
• Collaborators: Massachusetts Institute of Technology; VA Northern California Health Care System; San Mateo Medical Center
• Investigators: Principal Investigator: Stephen J Bonasera, MD, PhD, University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): December 15, 2010
• Primary Completion (Actual): October 31, 2012
• Study Completion (Actual): October 31, 2012

Study Registration Dates

• First Submitted: October 12, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimated): October 14, 2010

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 12, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: cognitive impairment; neuropsychological assessment; computer-aided diagnostic tool
• Additional Relevant MeSH Terms: Mental Disorders; Neurocognitive Disorders; Cognition Disorders; Cognitive Dysfunction
• Other Study ID Numbers: 0491-10-FB