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

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ClinicalTrials.gov Identifier: NCT01220674
Recruitment Status : Completed
First Posted : October 14, 2010
Last Update Posted : January 31, 2018
Sponsor:
Collaborators:
Massachusetts Institute of Technology
San Mateo Medical Center
VA Northern California Health Care System
Information provided by (Responsible Party):
Stephen Bonasera, University of Nebraska

Brief Summary:
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 or disease Intervention/treatment
Cognitive Impairment Other: cognitive testing

Study Type : Observational
Actual Enrollment : 152 participants
Observational Model: Ecologic or Community
Time Perspective: Other
Official Title: Pilot Testing a New Computer-based Screening Tool to Detect Cognitive Impairment
Actual Study Start Date : November 1, 2010
Primary Completion Date : October 31, 2012
Study Completion Date : October 31, 2012

Group/Cohort Intervention/treatment
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




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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.

Responsible Party: Stephen Bonasera, Principal Investigator, University of Nebraska
ClinicalTrials.gov Identifier: NCT01220674     History of Changes
Other Study ID Numbers: 491-10-FB
First Posted: October 14, 2010    Key Record Dates
Last Update Posted: January 31, 2018
Last Verified: January 2018

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

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