Neuropsychological Norms for Ethnically Diverse Florida Elders

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.

Study Overview

• Status: Unknown
• Conditions: Healthy
• Intervention / Treatment: Other: Neuropsychological Testing

• Study Type: Observational
• Enrollment (Anticipated): 350

Contacts and Locations

Study Locations

• United States
  • Florida
    • Jacksonville, Florida, United States, 32224
      • Recruiting
      • Mayo Clinic Florida
      • Contact: Johm Lucas, Ph.D; Phone Number: 904-953-2000; Email: Lucas.John@mayo.edu
    • Miami, Florida, United States, 33136
      • Recruiting
      • Mt. Sinai Medical Center
      • Contact: David Loewenstein, Ph.D; Phone Number: 305-355-9081; Email: DLoewenstein@med.miami.edu
    • Tampa, Florida, United States, 33612
      • Recruiting
      • University Of South Florida
      • Contact: Mike R Schoenberg, Ph.D; Phone Number: 813-974-8900; Email: mschoenb@health.usf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neuropsychological norms	Norm referenced scores from the sample population	1 year

Collaborators and Investigators

• Sponsor: University of South Florida
• Collaborators: Mayo Clinic; Florida Department of Health; Mt. Sinai Medical Center, Miami
• Investigators: Principal Investigator: John Lucas, Ph.D, Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): June 3, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Anticipated): September 1, 2017

Study Registration Dates

• First Submitted: June 22, 2017
• First Submitted That Met QC Criteria: June 22, 2017
• First Posted (Actual): June 26, 2017

Study Record Updates

• Last Update Posted (Actual): June 26, 2017
• Last Update Submitted That Met QC Criteria: June 22, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: FloridaElderNorms

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No