Parkinson's Disease in African American and Caucasian Patients

Sponsor

University of Chicago (Other)

Overall Status

Recruiting

CT.gov ID

NCT03279445

Collaborator

(none)

600

Enrollment

Location

40.7

Anticipated Duration (Months)

14.7

Patients Per Site Per Month

Study Details

Study Description

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	Phase
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 Design

Study Type:

Observational

Anticipated 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 :

Aug 9, 2017

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	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.

Arm

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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

The difference in genetic profiles in these two populations with PD [Through study completion - up to two years]
As above (drawing blood samples and running genetic tests)

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 100 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria: Non-PD

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Chicago Medical Center	Chicago	Illinois	United States	60637

Sponsors and Collaborators

University of Chicago

Investigators

Principal Investigator: Tao Xie, MD, PhD, University of Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of Chicago

ClinicalTrials.gov Identifier:

NCT03279445

Other Study ID Numbers:

IRB 17-0998

First Posted:

Sep 12, 2017

Last Update Posted:

Oct 8, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Parkinson Disease

Study Results

No Results Posted as of Oct 8, 2020