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Neuropsychological Norms for Ethnically Diverse Florida Elders

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.
 
ClinicalTrials.gov Identifier: NCT03199378
Recruitment Status : Unknown
Verified June 2017 by University of South Florida.
Recruitment status was:  Recruiting
First Posted : June 26, 2017
Last Update Posted : June 26, 2017
Sponsor:
Collaborators:
Mayo Clinic
Mt. Sinai Medical Center, Miami
Florida Department of Health
Information provided by (Responsible Party):
University of South Florida

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.

Condition or disease Intervention/treatment
Healthy Other: Neuropsychological Testing

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Study Type : Observational
Estimated Enrollment : 350 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Neuropsychological Norms for Ethnically Diverse Florida Elders
Actual Study Start Date : June 3, 2016
Estimated Primary Completion Date : September 1, 2017
Estimated Study Completion Date : September 1, 2017

Group/Cohort Intervention/treatment
Caucasian
English speaking Caucasian individuals
Other: Neuropsychological Testing
Each group will be administered a battery of neuropsychological tests

African American
English speaking African American individuals
Other: Neuropsychological Testing
Each group will be administered a battery of neuropsychological tests

Hispanic
Spanish speaking Hispanic individuals
Other: Neuropsychological Testing
Each group will be administered a battery of neuropsychological tests




Primary Outcome Measures :
  1. Neuropsychological norms [ Time Frame: 1 year ]
    Norm referenced scores from the sample population



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years to 105 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy individuals in the state of Florida who are over the age of 60 and self-identify as Hispanic, non-Hispanic Black/African American, or non-Hispanic Caucasian.
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.

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): NCT03199378


Contacts
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Contact: John Lucas, Ph.D 904-953-2000 lucas.john@mayo.edu

Locations
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United States, Florida
Mayo Clinic Florida Recruiting
Jacksonville, Florida, United States, 32224
Contact: Johm Lucas, Ph.D    904-953-2000    Lucas.John@mayo.edu   
Mt. Sinai Medical Center Recruiting
Miami, Florida, United States, 33136
Contact: David Loewenstein, Ph.D    305-355-9081    DLoewenstein@med.miami.edu   
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Mike R Schoenberg, Ph.D    813-974-8900    mschoenb@health.usf.edu   
Sponsors and Collaborators
University of South Florida
Mayo Clinic
Mt. Sinai Medical Center, Miami
Florida Department of Health
Investigators
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Principal Investigator: John Lucas, Ph.D Mayo Clinic

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Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT03199378     History of Changes
Other Study ID Numbers: FloridaElderNorms
First Posted: June 26, 2017    Key Record Dates
Last Update Posted: June 26, 2017
Last Verified: June 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No