Clinical trial NCT06719583: Black and African Americans Connections to Parkinson's Disease (BLAAC PD)
Official title: Black and African Americans Connections to Parkinson's Disease (BLAAC PD) a Project of the Global Parkinson's Genetics Program (GP2)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Parkinson Disease
Keywords: genetics
racial health disparities
Lead sponsor: Michael J. Fox Foundation for Parkinson's Research
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: University of Chicago
name: University of Alabama at Birmingham
name: Rush University
name: Washington University School of Medicine
name: Medical University of South Carolina
name: University Hospitals Cleveland Medical Center
name: Louisiana State University Health Sciences Center Shreveport
name: University of Florida
name: University of Maryland
name: The University of Texas Health Science Center, Houston
name: Ochsner Health System
First posted: 2024-12-06
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Black Americans and African Americans with Parkinson's Disease or without a history of Parkinson's (control volunteers).

Brief summary: BLAAC PD is a research study to understand what Parkinson's disease looks like for Black and African American communities.

BLAAC PD is happening at research centers around the United States. The study is part of the Global Parkinson's Genetics Program (GP2). GP2 is a research project working to transform understanding of the genetics of Parkinson's disease and make that knowledge globally relevant.

Detailed description: Research studies have found connections between genes and Parkinson's disease (PD). But those results have mostly come from studies with non-Black or African American volunteers. BLAAC PD aims to learn more about gene changes that may cause Parkinson's in Black and African American people. Study volunteers at sites across the United States will attend one visit and will give either a blood or saliva sample, complete a smell test, and may be asked to complete a physical exam. This new data could lead to future Parkinson's tests and treatments for Black and African American people and it may help better understand disease in other groups, too.

This pioneering initiative will fill a gap of knowledge about PD in Black and African American people.

Eligibility criteria: Inclusion Criteria for Control Participants:

* Ability to provide informed consent
* Age 18 years or older
* Self-identify as Black or African American

Exclusion Criteria for Control Participants:

* Diagnosis of Parkinson's Disease and/or neurological condition
* Familial history of PD and/or neurodegenerative or psychiatric conditions
* Unknown family history of PD and/or neurodegenerative or psychiatric conditions
* Any conditions that, in the investigator's opinion, preclude the individual's ability to carry out study activities
* If submitting a saliva sample, nothing by mouth (food, drink, gum, tobacco, or smoking) for 30 minutes prior to sample collection

Inclusion Criteria for Participants with a Diagnosis of PD:

* Ability to provide informed consent
* Age 18 years or older
* Self-identify as Black or African American
* Meet the Movement Disorder Society's clinical diagnostic criteria for Parkinson's disease

Exclusion Criteria for Participants with a Diagnosis of PD:

- If submitting a saliva sample, nothing by mouth (food, drink, gum, tobacco, or smoking) for 30 minutes prior to sample collection

Primary outcomes:
measure: Explore novel risk factors and characterization
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Chicago
country: United States
facility: Rush University
state: Illinois
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland
state: Maryland
city: Rockville
country: United States
facility: Kaiser Permanente Midatlantic States
state: Maryland
city: Saint Louis
country: United States
facility: Washington University in St. Louis
state: Missouri
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Houston
country: United States
facility: University of Texas Health Science Center, Houston
state: Texas
Study officials:
affiliation: National Institutes of Health (NIH)
name: Andrew Singleton, PhD
role: PRINCIPAL_INVESTIGATOR
References: