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Parkinson's Disease in African American and Caucasian Patients

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ClinicalTrials.gov Identifier: NCT03279445
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : September 12, 2017
Sponsor:
Information provided by (Responsible Party):
University of Chicago

Brief Summary:
More than 10 million people worldwide are living with Parkinson's disease (PD). While the actual number of African Americans with PD is unknown, it is clear that there are racial disparities in the access to health care, and diagnosis and treatment of PD. The lack of clear knowledge on the 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 large African American population. By analyzing the demographics, socioeconomics and clinical features of PD patients in our Center for Research Informatics in African Americans compared to the Caucasians of similar geographical area all accessible to the same health care facility, the Investigators aim to work toward a better understanding of the unique features of PD in American Americans, which might help improve the healthcare among the African Americans in Chicago and possibly nationwide. Blood will also be drawn during follow-up visits for future genetic studies, which might also help understand the genetic aspect of the disparity in PD.

Condition or disease Intervention/treatment
Parkinson Disease Genetic: Genetic testing

Detailed Description:

The first portion of study will be database search of patients with Parkinson's disease - which will not require seeing the patients or conducting assessments in the clinic space. The second portion will involve clinical assessment and blood drawl at routine clinic visit.

The investigators will focus on African American PD patients who have access to health insurance and are from a similar geographic location as white PD patients. Among these two populations, demographics and socioeconomic status will be compared. Disease features, such as the duration after the onset to have the first visit, severity of the disease at the first visit, compliance in follow-up, co-morbidity rates, and milestones of the disease progression (aspiration pneumonia, wheelchair bound, nursing home, death, etc.) will also be assessed. Socioeconomic status will also be factored into the analysis. The investigators will also compare information from the United Parkinson's Disease Rating Scale (UPDRS), Parkinson's Disease Questionnaire (PDQ-39), Montreal Cognitive Assessment (MoCA) and Schwab and England Activities of Daily Living (SEADL).

The genetic differences between blacks and whites with PD are poorly understood and studied. As such, the investigators will also be collecting blood samples at patients' follow-up visits for future genetic analysis, such as mutations in the LRRK2 and GBA genes and even GWAS study, to see if there are significant differences in the genetic profiles of African American and Caucasian PD patients that account for the low PD prevalence rate in the black population


Study Type : Observational
Estimated Enrollment : 600 participants
Observational Model: Ecologic or Community
Time Perspective: Other
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
Estimated Primary Completion Date : June 1, 2018
Estimated Study Completion Date : August 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
African American
Patient of African American race
Genetic: Genetic testing
Two tubes of blood samples for genetic testing.

Caucasian
Patient of Caucasian race
Genetic: Genetic testing
Two tubes of blood samples for genetic testing.




Primary Outcome Measures :
  1. Demographic information compared between African American and Caucasian population (year of diagnosis, symptom progression, healthcare details etc.) [ Time Frame: Through study completion - up to two years ]
    As above (through chart reviewing and additional visits as described)


Secondary Outcome Measures :
  1. The difference in genetic profiles in these two populations with PD [ Time Frame: Through study completion - up to two years ]
    As above (drawing blood samples and running genetic tests)


Biospecimen Retention:   Samples With DNA
Two tubes of blood of 8 ml each will be obtained from patients for genetic testing


Information from the National Library of Medicine

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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 Caucasian race.
Criteria

Inclusion Criteria:

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

Exclusion Criteria: Non-PD


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


Contacts
Contact: Tao Xie, MD, PhD 7737023038 txie@neurology.bsd.uchicago.edu
Contact: Breanna R Bertacchi, BA 7738341688 bbertacchi1@neurology.bsd.uchicago.edu

Locations
United States, Illinois
University of Chicago Medical Center Recruiting
Chicago, Illinois, United States, 60637
Contact: Tao Xie, MD, PhD    773-702-3081    txie@neurology.bsd.uchicago.edu   
Contact: Breanna R Bertacchi    773-834-1688    bbertacchi1@neurology.bsd.uchicago.edu   
Principal Investigator: Tao Xie, MD, PhD         
Sub-Investigator: Mahesh Padmanaban, MD         
Sponsors and Collaborators
University of Chicago
Investigators
Principal Investigator: Tao Xie, MD, PhD University of Chicago

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

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases