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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by University of Nebraska.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01220674
First Posted: October 14, 2010
Last Update Posted: October 14, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Massachusetts Institute of Technology
San Mateo Medical Center
VA Northern California Health Care System
Information provided by:
University of Nebraska
  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

Further study details as provided by University of Nebraska:

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

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Community-dwelling adults without significant cognitive impairment
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01220674


Contacts
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

Sponsors and Collaborators
University of Nebraska
Massachusetts Institute of Technology
San Mateo Medical Center
VA Northern California Health Care System
  More Information

Responsible Party: Annabelle Singer, Ph.D., Massachusetts Institute of Technology
ClinicalTrials.gov Identifier: NCT01220674     History of Changes
Other Study ID Numbers: 491-10-FB
First Submitted: October 12, 2010
First Posted: October 14, 2010
Last Update Posted: October 14, 2010
Last Verified: October 2010

Keywords provided by University of Nebraska:
neuropsychological assessment
cognitive impairment
computer-aided diagnostic tool

Additional relevant MeSH terms:
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders