Clinical trial NCT01220674: Pilot Testing a New Computer-based Screening Tool to Detect Cognitive Impairment
Official title: Pilot Testing a New Computer-based Screening Tool to Detect Cognitive Impairment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cognitive Impairment
Keywords: neuropsychological assessment
cognitive impairment
computer-aided diagnostic tool
Lead sponsor: University of Nebraska
Sponsor class: OTHER
Collaborators: name: Massachusetts Institute of Technology
name: San Mateo Medical Center
name: VA Northern California Health Care System
First posted: 2010-10-14
Enrollment: 152
Sex: ALL
Minimum age (years): 55
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Community-dwelling adults without significant cognitive impairment

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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Unversity of Nebraska Medical Center
state: Nebraska
Study officials:
affiliation: University of Nebraska
name: Stephen J Bonasera, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: