Pilot Testing a New Computer-based Screening Tool to Detect Cognitive Impairment
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Cognitive Impairment |
Other: cognitive testing |
| Study Type: | Observational |
| Study Design: | Observational Model: Ecologic or Community |
| Official Title: | Pilot Testing a New Computer-based Screening Tool to Detect Cognitive Impairment |
| Estimated Enrollment: | 300 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts | Assigned Interventions |
|---|---|
|
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
|
Eligibility| Ages Eligible for Study: | 55 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
Community-dwelling adults without significant cognitive impairment
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.
Contacts and Locations| Contact: Stephen J. Bonasera, M.D., Ph.D. | 402-559-8409 | sbonasera@unmc.edu |
| Contact: Jackie Whittington, R.N. | 402-559-6117 | jwhittington@unmc.edu |
More Information
No publications provided
| Responsible Party: | Annabelle Singer, Ph.D., Massachusetts Institute of Technology |
| ClinicalTrials.gov Identifier: | NCT01220674 History of Changes |
| Other Study ID Numbers: | 491-10-FB |
| Study First Received: | October 12, 2010 |
| Last Updated: | October 13, 2010 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by University of Nebraska:
|
neuropsychological assessment cognitive impairment computer-aided diagnostic tool |
Additional relevant MeSH terms:
|
Cognition Disorders Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013