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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01220674
Other study ID # 0491-10-FB
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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, 

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