Neuropsychological Norms for Ethnically Diverse Florida Elders

• Sponsor: University of South Florida (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT03199378
• Collaborator: Mayo Clinic (Other), Mt. Sinai Medical Center, Miami (Other), Florida Department of Health (Other)
• Enrollment: 350
• Locations: 3
• Anticipated Duration (Months): 14.9
• Patients Per Site: 116.7
• Patients Per Site Per Month: 7.8

Study Details

Study Description

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	Phase
Healthy	Other: Neuropsychological Testing

Study Design

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

Arms and Interventions

Arm	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

Outcome Measures

Primary Outcome Measures

1. Neuropsychological norms [1 year]

   Norm referenced scores from the sample population

Eligibility Criteria

Criteria

• Ages Eligible for Study: 60 Years to 105 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic Florida	Jacksonville	Florida	United States	32224
2	Mt. Sinai Medical Center	Miami	Florida	United States	33136
3	University of South Florida	Tampa	Florida	United States	33612

Sponsors and Collaborators

• University of South Florida
• Mayo Clinic
• Mt. Sinai Medical Center, Miami
• Florida Department of Health

Investigators

• Principal Investigator: John Lucas, Ph.D, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of South Florida
• ClinicalTrials.gov Identifier: NCT03199378
• Other Study ID Numbers: FloridaElderNorms
• First Posted: Jun 26, 2017
• Last Update Posted: Jun 26, 2017
• Last Verified: Jun 1, 2017

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

Study Results

No Results Posted as of Jun 26, 2017