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Status unknownNCT03199378Updated Jun 26, 2017

Neuropsychological Norms for Ethnically Diverse Florida Elders

An observational study in Healthy, sponsored by University of South Florida. Status unknown at 3 sites in United States. Open to participants aged 60 Years to 105 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-06-26.

Sponsored by University of South Florida · Observational

The sponsor has not verified this record recently (last verified Jun 2017), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Ecologic or community
Time perspective
Prospective
Enrollment
350
Ages
60 Years to 105 Years
Sex
All
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Study 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.

02

Conditions studied

  • Healthy
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In context

Lead sponsor

University of South Florida is the lead sponsor of 333 studies on the registry; 63 are open to participants now.

Of its 17 completed or terminated interventional studies of FDA-regulated products, 4 (24%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years to 105 Years
Sexes eligible
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.

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

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.
05

Study design

Observational model
Ecologic or community
Time perspective
Prospective
Enrollment
350 participants (estimated)
Patient registry
No

Groups and cohorts

  • Caucasian

    English speaking Caucasian individuals

    Other: Neuropsychological Testing

  • African American

    English speaking African American individuals

    Other: Neuropsychological Testing

  • Hispanic

    Spanish speaking Hispanic individuals

    Other: Neuropsychological Testing

Interventions

  • OtherNeuropsychological Testing

    Each group will be administered a battery of neuropsychological tests

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What researchers measure

Primary outcomes

  1. Neuropsychological norms

    Norm referenced scores from the sample population

    Time frame: 1 year

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Study locations

3 of 3 sites recruiting
  • Mayo Clinic Florida
    Jacksonville, Florida 32224, United States
    Recruiting
  • Mt. Sinai Medical Center
    Miami, Florida 33136, United States
    Recruiting
  • University of South Florida
    Tampa, Florida 33612, United States
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 26, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03199378
Lead sponsor
University of South Florida
Collaborators
Mayo Clinic, Mt. Sinai Medical Center, Miami, Florida Department of Health
Responsible party
Sponsor
First posted
Jun 26, 2017
Start date
Jun 3, 2016
Primary completion
Sep 1, 2017 (estimated)
Completion
Sep 1, 2017 (estimated)
Last update
Jun 26, 2017

Study contacts

John Lucas, Ph.D
Contact
lucas.john@mayo.edu
904-953-2000
John Lucas, Ph.D
principal investigator · Mayo Clinic

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2017. You cannot join it, but the record below documents what was studied.

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