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Completed

NCT Number: NCT07262658

Cognitive Disparities in Parkinson's Disease

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).

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Key information

Conditions

Parkinson Disease Basal Ganglia Diseases Brain Diseases Central Nervous System Diseases Movement Disorders Nervous System Diseases Neurodegenerative Diseases Parkinsonian Disorders Synucleinopathies

Age range

40 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

UC San Diego, La Jolla, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites

Other

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).

Primary outcomes

  1. Language (Letter Fluency)

    Time frame: Day 1 (day of enrollment)

  2. Language (Animal Fluency)

    Time frame: Day 1 (day of enrollment)

  3. Language (Vegetable Fluency)

    Time frame: Day 1 (day of enrollment)

  4. Language (Multilingual Naming Test)

    Time frame: Day 1 (day of enrollment)

  5. Speed of Information Processing

    Time frame: Day 1 (day of enrollment)

    Trail Making Test A

  6. Speed of Information Processing

    Time frame: Day 1 (day of enrollment)

    WAIS-III Digit Symbol

  7. Speed of Information Processing

    Time frame: Day 1 (day of enrollment)

    WAIS-III Symbol Search (Wechsler Adult Intelligence Scale)

  8. Attention/Working Memory

    Time frame: Day 1 (day of enrollment)

    PASAT-50 (Paced Auditory Serial Addition Test)

  9. Attention/Working Memory

    Time frame: Day 1 (day of enrollment)

    Number Span

  10. Executive Function

    Time frame: Day 1 (day of enrollment)

    Trail Making Test B

  11. Executive Function

    Time frame: Day 1 (day of enrollment)

    WCST-64 (Wisconsin Card Sorting Test)

  12. Verbal Learning and Memory

    Time frame: Day 1 (day of enrollment)

    Hopkins Verbal Learning Test-Revised

  13. Verbal Learning and Memory

    Time frame: Day 1 (day of enrollment)

    Craft Story Learning & Recall

  14. Visual Learning and Memory

    Time frame: Day 1 (day of enrollment)

    Brief Visuospatial Memory Test - Revised, Benson Figure Delay

  15. Visual-Spatial skills

    Time frame: Day 1 (day of enrollment)

    Benson Figure Copy

  16. Everyday Functioning

    Time frame: Day 1 (day of enrollment)

    Modified Lawton-Brody Instrumental Activities of Daily Living questionnaire

  17. 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

  18. diabetes mellitus

    Time frame: Day 1 (day of enrollment)

    fasting plasma glucose >126 mg/dL, an HbA1c >6.5%, or use of antihyperglycemic medications

  19. 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

  20. hypertension

    Time frame: Day 1 (day of enrollment)

    systolic blood pressure >140 mm Hg, diastolic blood pressure >90 mm Hg, or on antihypertensive medication

  21. current cigarette smoking

    Time frame: Day 1 (day of enrollment)

    Self-report

  22. obesity

    Time frame: Day 1 (day of enrollment)

    BMI of >30.0

  23. 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)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 4, 2025
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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