- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07262658
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
Completed
Conditions
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
Observational
Enrollment (Actual)
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 Locations
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California
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La Jolla, California, United States, 92037
- UC San Diego
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North Carolina
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Durham, North Carolina, United States, 27710
- Duke University
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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
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 |
Intervention / Treatment |
|---|---|
|
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).
|
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).
|
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
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Language (Letter Fluency)
Time Frame: Day 1 (day of enrollment)
|
Day 1 (day of enrollment)
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|
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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)
|
|
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Speed of Information Processing
Time Frame: Day 1 (day of enrollment)
|
Trail Making Test A
|
Day 1 (day of enrollment)
|
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Speed of Information Processing
Time Frame: Day 1 (day of enrollment)
|
WAIS-III Digit Symbol
|
Day 1 (day of enrollment)
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|
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)
|
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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)
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WCST-64 (Wisconsin Card Sorting Test)
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Day 1 (day of enrollment)
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Verbal Learning and Memory
Time Frame: Day 1 (day of enrollment)
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Hopkins Verbal Learning Test-Revised
|
Day 1 (day of enrollment)
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Verbal Learning and Memory
Time Frame: Day 1 (day of enrollment)
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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)
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Visual-Spatial skills
Time Frame: Day 1 (day of enrollment)
|
Benson Figure Copy
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Day 1 (day of enrollment)
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Everyday Functioning
Time Frame: Day 1 (day of enrollment)
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Modified Lawton-Brody Instrumental Activities of Daily Living questionnaire
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Day 1 (day of enrollment)
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Diagnosis of MCI/dementia in PD
Time Frame: Day 1 (day of enrollment)
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Objective presence of MCI and dementia in PD will be determined via comprehensive diagnostic criteria
|
Day 1 (day of enrollment)
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diabetes mellitus
Time Frame: Day 1 (day of enrollment)
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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)
|
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current cigarette smoking
Time Frame: Day 1 (day of enrollment)
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Self-report
|
Day 1 (day of enrollment)
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obesity
Time Frame: Day 1 (day of enrollment)
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BMI of >30.0
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Day 1 (day of enrollment)
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Parkinson's disease severity
Time Frame: Day 1 (day of enrollment)
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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
Investigators
- 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
- Litvan I, Goldman JG, Troster AI, Schmand BA, Weintraub D, Petersen RC, Mollenhauer B, Adler CH, Marder K, Williams-Gray CH, Aarsland D, Kulisevsky J, Rodriguez-Oroz MC, Burn DJ, Barker RA, Emre M. Diagnostic criteria for mild cognitive impairment in Parkinson's disease: Movement Disorder Society Task Force guidelines. Mov Disord. 2012 Mar;27(3):349-56. doi: 10.1002/mds.24893. Epub 2012 Jan 24.
- Marquine MJ, Rivera Mindt M, Umlauf A, Suarez P, Kamalyan L, Morlett Paredes A, Yassai-Gonzalez D, Scott TM, Heaton A, Diaz-Santos M, Gooding A, Artiola I Fortuny L, Heaton RK, Cherner M. Introduction to the Neuropsychological Norms for the US-Mexico Border Region in Spanish (NP-NUMBRS) Project. Clin Neuropsychol. 2021 Feb;35(2):227-235. doi: 10.1080/13854046.2020.1751882. Epub 2020 May 20.
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)
September 30, 2022
Primary Completion (Actual)
December 31, 2025
Study Completion (Actual)
December 31, 2025
Study Registration Dates
First Submitted
August 8, 2023
First Submitted That Met QC Criteria
December 1, 2025
First Posted (Estimated)
December 4, 2025
Study Record Updates
Last Update Posted (Actual)
January 15, 2026
Last Update Submitted That Met QC Criteria
January 14, 2026
Last Verified
January 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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