Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2025-12-25 @ 10:09 PM
Study NCT ID:
NCT07262658
Status:
RECRUITING
Last Update Posted:
2025-12-04
First Post:
2023-08-08
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Cognitive Disparities in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-01', 'studyFirstSubmitDate': '2023-08-08', 'studyFirstSubmitQcDate': '2025-12-01', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Language (Letter Fluency)', 'timeFrame': 'Day 1 (day of enrollment)'}, {'measure': 'Language (Animal Fluency)', 'timeFrame': 'Day 1 (day of enrollment)'}, {'measure': 'Language (Vegetable Fluency)', 'timeFrame': 'Day 1 (day of enrollment)'}, {'measure': 'Language (Multilingual Naming Test)', 'timeFrame': 'Day 1 (day of enrollment)'}, {'measure': 'Speed of Information Processing', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Trail Making Test A'}, {'measure': 'Speed of Information Processing', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'WAIS-III Digit Symbol'}, {'measure': 'Speed of Information Processing', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'WAIS-III Symbol Search (Wechsler Adult Intelligence Scale)'}, {'measure': 'Attention/Working Memory', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'PASAT-50 (Paced Auditory Serial Addition Test)'}, {'measure': 'Attention/Working Memory', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Number Span'}, {'measure': 'Executive Function', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Trail Making Test B'}, {'measure': 'Executive Function', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'WCST-64 (Wisconsin Card Sorting Test)'}, {'measure': 'Verbal Learning and Memory', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Hopkins Verbal Learning Test-Revised'}, {'measure': 'Verbal Learning and Memory', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Craft Story Learning \\& Recall'}, {'measure': 'Visual Learning and Memory', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Brief Visuospatial Memory Test - Revised, Benson Figure Delay'}, {'measure': 'Visual-Spatial skills', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Benson Figure Copy'}, {'measure': 'Everyday Functioning', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Modified Lawton-Brody Instrumental Activities of Daily Living questionnaire'}, {'measure': 'Diagnosis of MCI/dementia in PD', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Objective presence of MCI and dementia in PD will be determined via comprehensive diagnostic criteria'}, {'measure': 'diabetes mellitus', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'fasting plasma glucose \\>126 mg/dL, an HbA1c \\>6.5%, or use of antihyperglycemic medications'}, {'measure': 'hypercholesterolemia and dyslipidemia', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'total cholesterol \\>240 mg/dL, LDL cholesterol \\>160 mg/dL, or HDL cholesterol \\<40 mg/dL or on cholesterol-lowering medication'}, {'measure': 'hypertension', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'systolic blood pressure \\>140 mm Hg, diastolic blood pressure \\>90 mm Hg, or on antihypertensive medication'}, {'measure': 'current cigarette smoking', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'Self-report'}, {'measure': 'obesity', 'timeFrame': 'Day 1 (day of enrollment)', 'description': 'BMI of \\>30.0'}, {'measure': "Parkinson's disease severity", 'timeFrame': 'Day 1 (day of enrollment)', 'description': "Movement Disorders Society-Sponsored Revision of the Unified Parkinson's Disease Rating Scale (MDS-UPDRS)"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Parkinson Disease']}, 'referencesModule': {'references': [{'pmid': '22275317', 'type': 'BACKGROUND', 'citation': "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."}, {'pmid': '32431209', 'type': 'BACKGROUND', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'https://neurosciences.ucsd.edu/centers-programs/movement-disorders/research/801968-Neurocog-Flyer-SPANISH-06-Jun-2023-UCSD-IRB-Approved.pdf', 'label': 'recruitment flyer - Spanish'}, {'url': 'https://neurosciences.ucsd.edu/centers-programs/movement-disorders/research/801968-Neurocog-Flyer-ENGLISH.pdf', 'label': 'recruitment flyer - English'}, {'url': 'https://neurosciences.ucsd.edu/centers-programs/movement-disorders/research/pd-studies.html', 'label': "Research Studies - Parkinson's Disease"}]}, 'descriptionModule': {'briefSummary': "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).", 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 40 years old and older\n* non-Hispanic Whites\n* Hispanics\n* All genders\n* Ability to provide consent\n* Diagnosed with Parkinson's Disease\n\nExclusion Criteria:\n\n* Other neurological illness/diagnosis\n* Injury that would affect cognition (i.e. stroke, closed head injury with loss of consciousness for longer than 30 minutes)"}, 'identificationModule': {'nctId': 'NCT07262658', 'briefTitle': "Cognitive Disparities in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': "Disparities in Neurocognitive Impairment Among Hispanics/Latinos in the US With Parkinson's Disease: The Role of Cardiovascular Risk", 'orgStudyIdInfo': {'id': 'Pro00115158'}, 'secondaryIdInfos': [{'id': '801968', 'type': 'OTHER', 'domain': 'UC San Diego'}, {'id': 'Pro00115158', 'type': 'OTHER', 'domain': 'Duke University Health System'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Hispanics with Parkinson's Disease", 'description': '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).', 'interventionNames': ['Other: Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites']}, {'label': "non-Hispanic Whites with Parkinson's Disease", 'description': '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).', 'interventionNames': ['Other: Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites']}], 'interventions': [{'name': 'Will examine how Cardiovascular Disease risk, PD severity and social determinants impact neurocognitive impairment in Hispanics vs non-Hispanics Whites', 'type': 'OTHER', 'description': '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).', 'armGroupLabels': ["Hispanics with Parkinson's Disease", "non-Hispanic Whites with Parkinson's Disease"]}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'COMPLETED', 'country': 'United States', 'facility': 'UC San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Lizbeth Vera Murillo, MS', 'role': 'CONTACT', 'email': 'lizbeth.veramurillo@duke.edu', 'phone': '919-681-3957'}, {'name': 'Maria J Marquine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Lizbeth C Vera Murillo, MS', 'role': 'CONTACT', 'email': 'lizbeth.veramurillo@duke.edu', 'phone': '919-681-3957'}], 'overallOfficials': [{'name': 'Maria J Marquine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Study is conducted only at these sites, hence there is no need to share information with other investigators.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}