Cognitive Disparities in Parkinson's Disease

NCT ID: NCT07262658

Last Updated: 2026-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-09-30

Study Completion Date

2025-12-31

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Parkinson Disease

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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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).

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

Intervention Type 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).

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).

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

Intervention Type 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).

Interventions

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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).

Intervention Type OTHER

Eligibility Criteria

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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)
Minimum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maria J Marquine, PhD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

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UC San Diego

La Jolla, California, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 22275317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32431209 (View on PubMed)

Other Identifiers

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801968

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00115158

Identifier Type: OTHER

Identifier Source: secondary_id

Pro00115158

Identifier Type: -

Identifier Source: org_study_id

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