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

Completed

• Conditions: Cognitive Impairment
• Interventions: Other: cognitive testing

• Registration Number: NCT01220674
• Lead Sponsor: University of Nebraska

Brief Summary

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.

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 Timeline

• Study First Submitted: 2010-10-12
• Study First Submitted QC: 2010-10-13
• Study First Posted: 2010-10-14
• Study Start: 2010-12-15
• Primary Completion: 2012-10-31
• Study Completion: 2012-10-31
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-12
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 152

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
community dwelling older adults, normal controls	cognitive testing	men and women 55 years of age or older who are cognitively intact.
community dwelling older adults, mild cognitive impairment	cognitive testing	men and women 55 years of age or older who have minimal cognitive decline (MMSE 20-24).

Trial Locations

Locations (1)

Unversity of Nebraska Medical Center; 🇺🇸 Omaha, Nebraska, United States