Cognitive Disparities in Parkinson's Disease

January 14, 2026 updated by: Duke University

Disparities in Neurocognitive Impairment Among Hispanics/Latinos in the US With Parkinson's Disease: The Role of Cardiovascular Risk

This study will investigate disparities in neurocognitive impairment (NCI) among Hispanics/Latinos/as/x (henceforth Hispanics) living in the US-Mexico borderland of California or in North Carolina with Parkinson's Disease (PD) and determine mechanisms underlying these disparities. NCI is an important aspect of the clinical course of PD, particularly among Hispanics, who have increased prevalence of dementia. Among the many potential factors driving this disparity, the investigators chose to focus on a modifiable risk factor to which Hispanics are particularly vulnerable, and that has been linked to increased NCI, namely cardiovascular (CVD) risk (e.g., diabetes, hypertension, obesity).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The proposed study will use a cross-sectional design to determine the presence of NCI in 120 persons with PD (age 40+), living in the US-Mexico borderland of California or in North Carolina, including 60 Hispanics and 60 non-Hispanic Whites. All participants will complete comprehensive neuromedical and neuropsychological evaluations, a blood draw and assessments of socio-cultural factors (e.g., health literacy, access to care, acculturation, bilingualism, discrimination, socioeconomic status). Using these data we will examine the extent to which CVD risk (e.g., diabetes, hypertension, obesity), PD severity and social determinants of health drive NCI among Hispanics with PD. The present proposal will capitalize on the infrastructure and expertise available at Duke University and will follow a community-based participatory research approach to complete the proposed study aims.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • California
      • La Jolla, California, United States, 92037
        • UC San Diego
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The proposed study will use a cross-sectional design to determine the presence of NCI in 120 persons with PD (age 40+), including 60 Hispanics and 60 non-Hispanic Whites living in the US/Mexico borderland of California or in North Carolina.

Description

Inclusion Criteria:

  • 40 years old and older
  • non-Hispanic Whites
  • Hispanics
  • All genders
  • Ability to provide consent
  • Diagnosed with Parkinson's Disease

Exclusion Criteria:

  • Other neurological illness/diagnosis
  • Injury that would affect cognition (i.e. stroke, closed head injury with loss of consciousness for longer than 30 minutes)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Hispanics with Parkinson's Disease
All Hispanics with PD will complete comprehensive neuromedical and neuropsychological evaluations, a blood draw and assessments of socio-cultural factors (e.g., health literacy, access to care, acculturation, bilingualism, discrimination, socioeconomic status).
Other: Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites
All participants will complete comprehensive neuromedical and neuropsychological evaluations, a blood draw and assessments of socio-cultural factors (e.g., health literacy, access to care, acculturation, bilingualism, discrimination, socioeconomic status).
non-Hispanic Whites with Parkinson's Disease
All non-Hispanic Whites with PD will complete comprehensive neuromedical and neuropsychological evaluations, a blood draw and assessments of socio-cultural factors (e.g., health literacy, access to care, acculturation, bilingualism, discrimination, socioeconomic status).
Other: Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites
All participants will complete comprehensive neuromedical and neuropsychological evaluations, a blood draw and assessments of socio-cultural factors (e.g., health literacy, access to care, acculturation, bilingualism, discrimination, socioeconomic status).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Language (Letter Fluency)
Time Frame: Day 1 (day of enrollment)
Day 1 (day of enrollment)
Language (Animal Fluency)
Time Frame: Day 1 (day of enrollment)
Day 1 (day of enrollment)
Language (Vegetable Fluency)
Time Frame: Day 1 (day of enrollment)
Day 1 (day of enrollment)
Language (Multilingual Naming Test)
Time Frame: Day 1 (day of enrollment)
Day 1 (day of enrollment)
Speed of Information Processing
Time Frame: Day 1 (day of enrollment)
Trail Making Test A
Day 1 (day of enrollment)
Speed of Information Processing
Time Frame: Day 1 (day of enrollment)
WAIS-III Digit Symbol
Day 1 (day of enrollment)
Speed of Information Processing
Time Frame: Day 1 (day of enrollment)
WAIS-III Symbol Search (Wechsler Adult Intelligence Scale)
Day 1 (day of enrollment)
Attention/Working Memory
Time Frame: Day 1 (day of enrollment)
PASAT-50 (Paced Auditory Serial Addition Test)
Day 1 (day of enrollment)
Attention/Working Memory
Time Frame: Day 1 (day of enrollment)
Number Span
Day 1 (day of enrollment)
Executive Function
Time Frame: Day 1 (day of enrollment)
Trail Making Test B
Day 1 (day of enrollment)
Executive Function
Time Frame: Day 1 (day of enrollment)
WCST-64 (Wisconsin Card Sorting Test)
Day 1 (day of enrollment)
Verbal Learning and Memory
Time Frame: Day 1 (day of enrollment)
Hopkins Verbal Learning Test-Revised
Day 1 (day of enrollment)
Verbal Learning and Memory
Time Frame: Day 1 (day of enrollment)
Craft Story Learning & Recall
Day 1 (day of enrollment)
Visual Learning and Memory
Time Frame: Day 1 (day of enrollment)
Brief Visuospatial Memory Test - Revised, Benson Figure Delay
Day 1 (day of enrollment)
Visual-Spatial skills
Time Frame: Day 1 (day of enrollment)
Benson Figure Copy
Day 1 (day of enrollment)
Everyday Functioning
Time Frame: Day 1 (day of enrollment)
Modified Lawton-Brody Instrumental Activities of Daily Living questionnaire
Day 1 (day of enrollment)
Diagnosis of MCI/dementia in PD
Time Frame: Day 1 (day of enrollment)
Objective presence of MCI and dementia in PD will be determined via comprehensive diagnostic criteria
Day 1 (day of enrollment)
diabetes mellitus
Time Frame: Day 1 (day of enrollment)
fasting plasma glucose >126 mg/dL, an HbA1c >6.5%, or use of antihyperglycemic medications
Day 1 (day of enrollment)
hypercholesterolemia and dyslipidemia
Time Frame: Day 1 (day of enrollment)
total cholesterol >240 mg/dL, LDL cholesterol >160 mg/dL, or HDL cholesterol <40 mg/dL or on cholesterol-lowering medication
Day 1 (day of enrollment)
hypertension
Time Frame: Day 1 (day of enrollment)
systolic blood pressure >140 mm Hg, diastolic blood pressure >90 mm Hg, or on antihypertensive medication
Day 1 (day of enrollment)
current cigarette smoking
Time Frame: Day 1 (day of enrollment)
Self-report
Day 1 (day of enrollment)
obesity
Time Frame: Day 1 (day of enrollment)
BMI of >30.0
Day 1 (day of enrollment)
Parkinson's disease severity
Time Frame: Day 1 (day of enrollment)
Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Day 1 (day of enrollment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Duke University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Maria J Marquine, PhD, Duke University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 8, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2025

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 4, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Pro00115158 (Other Identifier: Duke University Health System)
  • 801968 (Other Identifier: UC San Diego)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Study is conducted only at these sites, hence there is no need to share information with other investigators.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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