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

Cognitive Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220674
• Other study ID #: 0491-10-FB
• Status: Completed
• Start date: December 15, 2010
• Est. completion date: October 31, 2012

Study information

• Verified date: September 2023
• Source: University of Nebraska
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 152
• Est. completion date: October 31, 2012
• Est. primary completion date: October 31, 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment

Intervention

Other:
• cognitive testing
computer-based cognitive assessment

Locations

Country	Name	City	State
United States	Unversity of Nebraska Medical Center	Omaha	Nebraska

Sponsors (4)

Lead Sponsor	Collaborator
University of Nebraska	Massachusetts Institute of Technology, San Mateo Medical Center, VA Northern California Health Care System

Country where clinical trial is conducted

United States,