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Parkinson's Disease in African American and Caucasian Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03279445
Recruitment Status : Completed
First Posted : September 12, 2017
Last Update Posted : May 8, 2023
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Study Description
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Brief Summary:
More than 10 million people worldwide are living with Parkinson's disease (PD). While the actual number of African American (or Black) patients with PD is unknown, it is clear that there are racial disparities in the access to health care, diagnosis, treatment and survival of PD. The lack of clear knowledge on the possibly lower PD prevalence among African Americans compared to Caucasians further calls for more research in this field. The University of Chicago Medicine is an ideal facility to study this topic, due to its location on the South Side of Chicago with a large African American (or Black) population. By analyzing the demographics, socioeconomics and clinical features of PD patients in our Center for Research Informatics in African American (or Black) patients compared to the Caucasians of similar geographical area, the investigators aim to work toward a better understanding of the unique features of PD in American American (or Black) population, which might help improve the healthcare among this population in the Chicago and possibly nationwide as well.

Condition or disease
Parkinson Disease

Detailed Description:

The first portion of the study will be a large medical electronic data based search and analysis of patients with PD on demographics, socioeconomic status and clinical features of PD patients. Specifically, we will retrospectively identify PD patients on both races from the electronic medical database spanned from 1/1/2006 to 10/31/2017 and compared demographics, socioeconomic status (educations, incomes and insurances), co-morbidities (all categories, including mood, cognition and psychosis), treatment (medications for parkinsonism and major non-motor symptoms, and frequency and locations of healthcare) and survival, and identified factors associated with medication usage and survival.

The second portion was designed to collect more detailed clinical assessments for information not available in the database and blood draws for genetic or candidate gene mutation analysis. Unfortunately, this part of the study could not be carried out due to the COVID-19 pandemic, which began shortly after completion of the first portion of the study. These assessments and analyses would have helped determine if there are significant differences in the clinical and genetic profiles between the African American (or Black) and Caucasian PD patients that account for their differences in clinical features and PD prevalence in these two populations.

Study Design
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Study Type : Observational
Actual Enrollment : 2033 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Characteristics of African American People With Parkinson's Disease: A Hospital Based Study at the University of Chicago of the African American Community in Chicago's South Side
Actual Study Start Date : August 9, 2017
Actual Primary Completion Date : April 10, 2020
Actual Study Completion Date : April 10, 2021

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
African American
Patient of African American race
Caucasian
Patient of Caucasian race


Outcome Measures
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Primary Outcome Measures :
  1. Disparities in diagnosis, treatment and survival between Black and White Parkinson patients [ Time Frame: Through study completion, an average of one year ]
    We will compare Black/AA and White PD patients on demographics, socioeconomic status (education, income, and insurance), co-morbidities, treatment (medications for parkinsonism and major non-motor symptoms, and frequency and locations of healthcare) and survival, and identify factors associated with medication usage and survival.


Biospecimen Retention:   None Retained
As described in the Study Description above for details on study design. Two tubes of blood of 8 ml each will be obtained from patients for future genetic testing

Eligibility Criteria
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Ages Eligible for Study:   15 Years to 100 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Parkinson's patients of either African American (or Black) or Caucasian race.
Criteria

Inclusion Criteria:

  • 15 years and older, confirmed diagnosis of PD, African American (or Black) or Caucasian race

Exclusion Criteria: Non-PD

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Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279445


Locations
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United States, Illinois
University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Sponsors and Collaborators
University of Chicago
Investigators
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Principal Investigator: Tao Xie, MD, PhD University of Chicago
More Information
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Publications:

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Responsible Party: University of Chicago
ClinicalTrials.gov Identifier: NCT03279445    
Other Study ID Numbers: IRB 17-0998
First Posted: September 12, 2017    Key Record Dates
Last Update Posted: May 8, 2023
Last Verified: May 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases