Parkinson DiseaseNCT07262658
Cognitive Disparities in Parkinson's Disease
An observational study of Parkinson Disease, run by Duke University at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites
- How many people
- 40 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Sep 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 40 years old and older
- non-Hispanic Whites
- Hispanics
- All genders
- Ability to provide consent
- Diagnosed with Parkinson's Disease
Who cannot join
- Other neurological illness/diagnosis
- Injury that would affect cognition (i.e. stroke, closed head injury with loss of consciousness for longer than 30 minutes)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Duke University
Durham, North Carolina, 27710
UC San Diego
La Jolla, California, 92037
About this study
Official title: 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).
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics WhitesOther
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites | |
| 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). Receives: Other: Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites |
What is being measured
The primary outcome is the main question the study is designed to answer.
Language (Letter Fluency)
Measured: Day 1 (day of enrollment)
Language (Animal Fluency)
Measured: Day 1 (day of enrollment)
Language (Vegetable Fluency)
Measured: Day 1 (day of enrollment)
Language (Multilingual Naming Test)
Measured: Day 1 (day of enrollment)
Speed of Information Processing
Trail Making Test A
Measured: Day 1 (day of enrollment)
Speed of Information Processing
WAIS-III Digit Symbol
Measured: Day 1 (day of enrollment)
Speed of Information Processing
WAIS-III Symbol Search (Wechsler Adult Intelligence Scale)
Measured: Day 1 (day of enrollment)
Attention/Working Memory
PASAT-50 (Paced Auditory Serial Addition Test)
Measured: Day 1 (day of enrollment)
Attention/Working Memory
Number Span
Measured: Day 1 (day of enrollment)
Executive Function
Trail Making Test B
Measured: Day 1 (day of enrollment)
Executive Function
WCST-64 (Wisconsin Card Sorting Test)
Measured: Day 1 (day of enrollment)
Verbal Learning and Memory
Hopkins Verbal Learning Test-Revised
Measured: Day 1 (day of enrollment)
Verbal Learning and Memory
Craft Story Learning \& Recall
Measured: Day 1 (day of enrollment)
Visual Learning and Memory
Brief Visuospatial Memory Test - Revised, Benson Figure Delay
Measured: Day 1 (day of enrollment)
Visual-Spatial skills
Benson Figure Copy
Measured: Day 1 (day of enrollment)
Everyday Functioning
Modified Lawton-Brody Instrumental Activities of Daily Living questionnaire
Measured: Day 1 (day of enrollment)
Diagnosis of MCI/dementia in PD
Objective presence of MCI and dementia in PD will be determined via comprehensive diagnostic criteria
Measured: Day 1 (day of enrollment)
diabetes mellitus
fasting plasma glucose >126 mg/dL, an HbA1c >6.5%, or use of antihyperglycemic medications
Measured: Day 1 (day of enrollment)
hypercholesterolemia and dyslipidemia
total cholesterol >240 mg/dL, LDL cholesterol >160 mg/dL, or HDL cholesterol <40 mg/dL or on cholesterol-lowering medication
Measured: Day 1 (day of enrollment)
hypertension
systolic blood pressure >140 mm Hg, diastolic blood pressure >90 mm Hg, or on antihypertensive medication
Measured: Day 1 (day of enrollment)
current cigarette smoking
Self-report
Measured: Day 1 (day of enrollment)
obesity
BMI of >30.0
Measured: Day 1 (day of enrollment)
Parkinson's disease severity
Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)
Measured: Day 1 (day of enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start30 Sep 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maria J Marquine, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262658
- Sponsor's protocol ID
- Pro00115158
- Other IDs
- 801968, Pro00115158
- Status last verified
- Jan 2026
- First submitted
- 8 Aug 2023
- Last updated
- 15 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Study is conducted only at these sites, hence there is no need to share information with other investigators.
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.
PubMed 22275317Marquine 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.
PubMed 32431209
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disparities in Neurocognitive Impairment Among Hispanics/Latinos in the US With Parkinson's Disease: The Role of Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT07262658
- Acronym / sponsor ID
- Pro00115158
- Conditions
- Parkinson Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 30 Sep 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hispanics with Parkinson's Disease | – | Other: Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics WhitesAll 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). |
| non-Hispanic Whites with Parkinson's Disease | – | Other: Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics WhitesAll 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). |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 40 years old and older
- non-Hispanic Whites
- Hispanics
- All genders
- Ability to provide consent
Key exclusion criteria (2 listed)
- Other neurological illness/diagnosis
- Injury that would affect cognition (i.e. stroke, closed head injury with loss of consciousness for longer than 30 minutes)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics WhitesAll 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). | Other | Hispanics with Parkinson's Disease, non-Hispanic Whites with Parkinson's Disease |
Primary outcome
Language (Letter Fluency)
Time frame: Day 1 (day of enrollment)
Language (Animal Fluency)
Time frame: Day 1 (day of enrollment)
Language (Vegetable Fluency)
Time frame: Day 1 (day of enrollment)
Language (Multilingual Naming Test)
Time frame: Day 1 (day of enrollment)
Speed of Information Processing
Time frame: Day 1 (day of enrollment)
Trail Making Test A
Speed of Information Processing
Time frame: Day 1 (day of enrollment)
WAIS-III Digit Symbol
Speed of Information Processing
Time frame: Day 1 (day of enrollment)
WAIS-III Symbol Search (Wechsler Adult Intelligence Scale)
Attention/Working Memory
Time frame: Day 1 (day of enrollment)
PASAT-50 (Paced Auditory Serial Addition Test)
Attention/Working Memory
Time frame: Day 1 (day of enrollment)
Number Span
Executive Function
Time frame: Day 1 (day of enrollment)
Trail Making Test B
Executive Function
Time frame: Day 1 (day of enrollment)
WCST-64 (Wisconsin Card Sorting Test)
Verbal Learning and Memory
Time frame: Day 1 (day of enrollment)
Hopkins Verbal Learning Test-Revised
Verbal Learning and Memory
Time frame: Day 1 (day of enrollment)
Craft Story Learning \& Recall
Visual Learning and Memory
Time frame: Day 1 (day of enrollment)
Brief Visuospatial Memory Test - Revised, Benson Figure Delay
Visual-Spatial skills
Time frame: Day 1 (day of enrollment)
Benson Figure Copy
Everyday Functioning
Time frame: Day 1 (day of enrollment)
Modified Lawton-Brody Instrumental Activities of Daily Living questionnaire
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
diabetes mellitus
Time frame: Day 1 (day of enrollment)
fasting plasma glucose >126 mg/dL, an HbA1c >6.5%, or use of antihyperglycemic medications
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
hypertension
Time frame: Day 1 (day of enrollment)
systolic blood pressure >140 mm Hg, diastolic blood pressure >90 mm Hg, or on antihypertensive medication
current cigarette smoking
Time frame: Day 1 (day of enrollment)
Self-report
obesity
Time frame: Day 1 (day of enrollment)
BMI of >30.0
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jan 2026.
- Background: PubMed 22275317Litvan 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.
- Background: PubMed 32431209Marquine 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.
- recruitment flyer - SpanishLink provided by the sponsor.
- recruitment flyer - EnglishLink provided by the sponsor.
- Research Studies - Parkinson's DiseaseLink provided by the sponsor.
- Individual participant dataSharing planned: No. Study is conducted only at these sites, hence there is no need to share information with other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria J Marquine, PhD principal investigator
Duke University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Parkinson Disease, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Language (Letter Fluency) (time frame: Day 1 (day of enrollment)). The study lists 23 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07262658, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.