NCT03199378

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2016

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 3, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 22, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 26, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 26, 2017

Status Verified

June 1, 2017

Enrollment Period

1.2 years

First QC Date

June 22, 2017

Last Update Submit

June 22, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Neuropsychological norms

    Norm referenced scores from the sample population

    1 year

Study Arms (3)

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

Neuropsychological TestingOTHER

Each group will be administered a battery of neuropsychological tests

African AmericanCaucasianHispanic

Eligibility Criteria

Age60 Years - 105 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

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

MeSH Terms

Interventions

Neuropsychological Tests

Intervention Hierarchy (Ancestors)

Psychological TestsBehavioral Disciplines and Activities

Study Officials

  • John Lucas, Ph.D

    Mayo Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

John Lucas, Ph.D

CONTACT

904-953-2000lucas.john@mayo.edu

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 22, 2017

First Posted

June 26, 2017

Study Start

June 3, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

June 26, 2017

Record last verified: 2017-06

Locations

US(3)