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Clinical Trials/NCT03199378
NCT03199378
Unknown
Not Applicable

Neuropsychological Norms for Ethnically Diverse Florida Elders

University of South Florida3 sites in 1 country350 target enrollmentJune 3, 2016
ConditionsHealthy

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Healthy
Sponsor
University of South Florida
Enrollment
350
Locations
3
Primary Endpoint
Neuropsychological norms
Last Updated
8 years ago

Overview

Brief Summary

The goal of this proposal is to collect normative data from a sample of ethnically diverse Florida elders on a brief, standardized neuropsychological test battery . The norms collected in this multi-cultural dataset will provide appropriate corrections for demographic and sociocultural variables that contribute to performance variance on neuropsychological tests. By accounting for these variables, the normative corrections will improve specificity and eliminate disparities in diagnostic validity and clinical utility of neuropsychological tests when administered to Florida's ethnic minority elders.

Registry
clinicaltrials.gov
Start Date
June 3, 2016
End Date
September 1, 2017
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Age 60 or above.
  • Any gender.
  • Primary language of English or Spanish.
  • Self-identifies as Hispanic, non-Hispanic Black/African American, or non-Hispanic Caucasian.
  • Global Clinical Dementia Rating (CDR) score = 0.

Exclusion Criteria

  • Memory decline reported by participant, informant (if available), or study clinician.
  • Currently uncontrolled health condition that could affect cognition.
  • Abnormal findings on current neurologic examination.
  • History of chronic neurological diseases (stroke, active seizure disorder, parkisonism, TBI with subsequent cognitive change.
  • Current substance abuse or history of substance dependence.
  • History of chronic psychiatric disease (Bipolar disorder, schizophrenia).
  • Currently active mood disorder. History of depression or anxiety is acceptable if symptoms are controlled (Score \<6 on the Geriatric Depression Scale). If taking psychoactive mood medication dosage must be stable for at least one month prior to testing.
  • Use of cognitive enhancing medications (i.e. cholinesterase inhibitors, memantine).
  • Need for assistance in activities of daily living due to cognitive reasons.
  • Sensorimotor deficits that would interfere with ability to perform neuropsychological tests.

Outcomes

Primary Outcomes

Neuropsychological norms

Time Frame: 1 year

Norm referenced scores from the sample population

Study Sites (3)

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