Clinical trial NCT03199378: Neuropsychological Norms for Ethnically Diverse Florida Elders
Official title: Neuropsychological Norms for Ethnically Diverse Florida Elders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
name: Mt. Sinai Medical Center, Miami
name: Florida Department of Health
First posted: 2017-06-26
Enrollment: 350
Sex: ALL
Minimum age (years): 60
Maximum age (years): 105
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
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.

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.


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.

Primary outcomes:
measure: Neuropsychological norms
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Miami
country: United States
facility: Mt. Sinai Medical Center
state: Florida
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: John Lucas, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: