BLAAC PD - Black and African Americans Connections to PD (NCT06719583)

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BLAAC PD - Black and African Americans Connections to Parkinson's Disease (NCT06719583)

Status: Recruiting Type: Observational Sponsor: Michael J. Fox Foundation Enrollment: 500 participants Study Start: January 2024 Estimated Completion: December 2027

Overview

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BLAAC PD (Black and African Americans Connections to Parkinson's Disease) is an observational study led by the Michael J. Fox Foundation addressing critical health disparities in Parkinson's disease research.[@health2024] This study focuses on understanding how Parkinson's disease affects Black and African American communities, with the goal of improving representation in PD research and addressing healthcare inequities.[@michael]

Background

...

BLAAC PD - Black and African Americans Connections to Parkinson's Disease (NCT06719583)

Status: Recruiting Type: Observational Sponsor: Michael J. Fox Foundation Enrollment: 500 participants Study Start: January 2024 Estimated Completion: December 2027

Overview

Mermaid diagram (expand to render)

Background

Health Disparities in Parkinson's Disease

Historical underrepresentation of minority populations in PD research has created significant knowledge gaps:[@diverse2023]

Limited data: Most PD studies are conducted in predominantly white cohorts
Genetic diversity: Lack of representation limits understanding of genetic factors
Clinical presentation: Possible differences in symptom presentation
Treatment access: Disparities in diagnosis and treatment

The Need for BLAAC PD

This study addresses:

Representation: Ensuring Black and African American participation in PD research

Data collection: Gathering comprehensive clinical data from underrepresented populations

Genetic characterization: Understanding genetic contributors in diverse populations

Access barriers: Identifying and addressing barriers to research participation

Study Design

| Parameter | Value |
|-----------|-------|
| Design | Cross-sectional and longitudinal observational |
| Focus | Health disparities in Black/African American PD patients |
| Arms | PD patients vs. healthy controls |
| Duration | 3-year enrollment and follow-up |

Inclusion Criteria

Race/Ethnicity: Self-identified Black or African American

Age: 40 years and older

Diagnosis: Parkinson's disease (research criteria) or healthy control

Ability to participate: Can complete study assessments

Exclusion Criteria

Secondary Parkinsonism: Parkinson-plus syndromes

Medical conditions: Significant comorbidities affecting participation

Cognitive impairment: Severe dementia preventing consent

Study Objectives

Primary Objectives

Recruitment: Enroll 500 Black/African American participants

Characterization: Detailed clinical characterization of PD in this population

Genetics: Genetic analysis to identify population-specific variants

Biomarkers: Collection of biosamples for biomarker development

Secondary Objectives

Compare phenotypes: Compare PD presentation to white cohorts

Barriers assessment: Identify barriers to research participation

Care access: Assess diagnostic delay and treatment access

Education: Develop culturally appropriate educational materials

Data Collection

Clinical Assessments

Motor function: MDS-UPDRS motor examination
Non-motor symptoms: Cognition, mood, sleep, autonomic function
Quality of life: PDQ-39, other patient-reported outcomes
Medical history: Detailed symptom and treatment history

Biosamples

Blood: DNA, plasma, serum
CSF: Cerebrospinal fluid (subset)
Saliva: For biomarker studies

Additional Data

Genetics: Whole genome sequencing
Imaging: MRI (subset)
Environmental exposures: Lifestyle and occupational history

Scientific Impact

Importance of Diversity in PD Research

Understanding PD in diverse populations:

Genetic insights: Different genetic backgrounds may reveal novel risk factors
Clinical variation: May identify different phenotype presentations
Treatment response: Understanding response differences
Health disparities: Identifying and addressing healthcare inequities

Expected Outcomes

Representative cohort: First large-scale Black/African American PD cohort
Genetic data: Population-specific genetic variants
Clinical phenotyping: Characterize PD presentation in this population
Future trials: Infrastructure for future clinical trial inclusion

Michael J. Fox Foundation for Parkinson's Disease Research

The Michael J. Fox Foundation (MJFF) is the world's leading nonprofit funder of Parkinson's disease research, having invested over $1.5 billion since its founding in 2000. The foundation's mission is to find a cure for Parkinson's disease through funded research and clinical trial infrastructure development.

Foundation Programs

Fox Insight: MJFF's flagship patient registry program that collects self-reported data from individuals with Parkinson's disease and healthy controls. This massive longitudinal dataset provides valuable phenotypic information for research.

Clinical Trial Readiness Programs: The foundation has established networks of clinical trial sites prepared to conduct PD research, reducing startup time for new studies.

The Parkinson's Progression Markers Initiative (PPMI): A landmark biomarker study that has enrolled over 1,500 participants including individuals with PD, at-risk carriers of PD genes, and healthy controls.

MJFF Research Priorities

Alpha-synuclein research: Funding therapeutic approaches targeting alpha-synuclein aggregation

Genetic causes of PD: Supporting research into LRRK2, GBA, SNCA, and other PD-associated genes

Biomarker development: Finding objective measures of disease progression and treatment response

Neuroprotective therapies: Developing disease-modifying treatments

Precision medicine: Tailoring treatments to individual genetic profiles

Foundation Impact on Clinical Trials

The Michael J. Fox Foundation has been instrumental in advancing PD clinical trials:

De-risking research: Providing funding for early-stage projects that might not otherwise receive support
Patient engagement: Building a community of engaged research participants through Fox Insight
Data sharing: Creating open-access datasets that accelerate research
Regulatory engagement: Working with FDA to advance drug development endpoints

Study Design Details

Cross-Sectional Assessment Protocol

The cross-sectional component establishes baseline characteristics:

Visit 1 (Screening): Consent, eligibility verification, basic demographics

Visit 2 (Baseline): Complete motor and non-motor assessments, biosample collection

Optional Visit 3: Imaging substudy participants

Longitudinal Follow-Up Protocol

Participants are followed over the 3-year study period:

Month 6: Brief telephone assessment
Year 1: In-person comprehensive assessment
Year 2: In-person comprehensive assessment
Year 3: In-person comprehensive assessment and study completion

Biosample Processing and Storage

All collected biosamples follow standardized protocols:

Blood Processing:

Whole blood collected in EDTA tubes for plasma separation
Whole blood collected in PAXgene tubes for RNA isolation
Serum separator tubes for biomarker studies
Processing within 2 hours of collection
Aliquoted and stored at -80°C

CSF Collection Protocol:

Lumbar puncture performed by trained neurologists
Collection in polypropylene tubes
Centrifugation within 1 hour
Stored in 0.5 mL aliquots at -80°C
Dedicated for biomarker analysis

DNA Extraction and Genotyping:

Standard salting-out method or automated extraction
Whole genome sequencing for all participants
Quality control metrics for sample integrity
Population stratification analysis

Statistical Considerations

Power Analysis:

Target enrollment of 500 provides 80% power to detect effect sizes of 0.25 with α=0.05
Allows for subgroup analyses by genetic status
Provides adequate sample for novel variant discovery

Primary Analyses:

Descriptive statistics for all demographic and clinical variables
Comparison of PD phenotypes with published white cohort data
Genetic variant frequency estimation

Clinical Phenotyping Details

Motor Assessment Battery

The motor examination follows MDS-UPDRS Part III standardized protocol:

Assessment Components:

Speech evaluation (item 1)

Facial expression (item 2)

Rigidity assessment (items 3-6)

Finger tapping (items 7-10)

Hand movements (items 11-14)

Pronation-supination (items 15-18)

Toe tapping (items 19-22)

Leg agility (items 23-26)

Arising from chair (item 27)

Gait (items 28-30)

Freezing of gait (item 31)

Postural stability (item 32)

Postural tremor (item 33)

Kinetic tremor (items 34-38)

Assessment Conditions:

OFF medication assessment (withdrawal ≥12 hours)
ON medication assessment (1-2 hours after usual medication)
Video recording for central reading (subset)

Non-Motor Assessment Battery

Cognitive Assessment:

Montreal Cognitive Assessment (MoCA)
Trail Making Test A and B
Digit Span Forward and Backward
Word List Learning and Recall

Psychiatric Assessment:

Beck Depression Inventory (BDI-II)
State-Trait Anxiety Inventory (STAI)
Parkinson's Disease Questionnaire (PDQ-39) - emotional well-being subdomain
Apathy Evaluation Scale

Sleep Assessment:

Parkinson's Disease Sleep Scale (PDSS-2)
Epworth Sleepiness Scale (ESS)
REM Sleep Behavior Disorder Screening Questionnaire (RBDSQ)

Autonomic Assessment:

Orthostatic blood pressure measurements
urinary symptom questionnaire
gastrointestinal symptom inventory

Quality of Life Measures

PDQ-39:

39 items across 8 domains
Mobility, activities of daily living, emotional well-being, stigma, social support, communication, bodily discomfort, cognition
Standardized to 0-100 scale

SF-36:

Generic health status measure
Physical and mental component scores
Allows comparison with general population

Genetic Analysis Plan

Whole Genome Sequencing Protocol

Sequencing Parameters:

30x coverage minimum
Illumina NovaSeq or equivalent platform
Alignment to GRCh38 reference
Variant calling following GATK best practices

Quality Control:

Sample-level: call rate >98%, contamination <3%
Variant-level: genotype quality score >30, read depth >10
Population outliers identified via PCA

Variant Annotation and Interpretation

Computational Tools:

ANNOVAR for functional annotation
SIFT and PolyPhen for pathogenicity prediction
CADD for variant deleteriousness scoring
ClinVar database for known pathogenic variants

Variant Classification:

Pathogenic, Likely Pathogenic, Variant of Uncertain Significance (VUS), Likely Benign, Benign
Following ACMG guidelines

Gene-Specific Analysis

PD-Associated Genes:

LRRK2: G2019S, R1441C/H/G, N1437H, Y1699C
GBA: N409S, L444P, E326K, T369M
SNCA: A53T, A30P, duplications
PARK2 (parkin), PARK7 (DJ-1), PINK1, ATP13A2
VPS35: D620N
DNAJC13, RAB39B, SYNJ1

Additional Analysis:

Polygenic risk score calculation
Novel gene discovery in familial cases
Founder mutation identification

Health Equity and Research Design

Historical Context

Underrepresentation in PD Research:

Prior to 2020, less than 5% of PD clinical trial participants were from minority populations
Genetic studies heavily biased toward European ancestry
Clinical phenotypic data primarily from white cohorts
Healthcare access disparities affect diagnosis and treatment

Barriers to Participation

Identified Barriers:

Geographic: Trial sites concentrated in major academic centers

Financial: Indirect costs of participation (transportation, time off work)

Cultural: Mistrust of medical research, lack of culturally appropriate materials

Logistical: Childcare, work schedules, transportation

Knowledge: Limited awareness of research opportunities

Study Solutions

BLAAC PD Addressing Barriers:

Site selection in areas with significant Black populations
Community-based recruitment through churches and community organizations
Flexible scheduling including evening and weekend appointments
Reimbursement for travel and time
Culturally sensitive study staff and materials
Partnerships with Black neurologists and healthcare providers

Community Engagement

Stakeholder Engagement:

Advisory board including Black PD patients and caregivers
Community advisory councils in each study region
Focus groups to inform study design and recruitment strategies
Patient navigation support throughout study participation

Scientific Impact and Future Directions

Anticipated Scientific Contributions

1. Genetic Data:

First large-scale whole genome sequencing dataset from Black PD patients
Novel variant discovery in known PD genes
Population-specific risk allele identification
Refinement of polygenic risk scores for this population

2. Clinical Phenotypic Data:

Comprehensive characterization of PD symptoms in Black patients
Comparison with white cohorts to identify similarities and differences
Identification of potential phenotype modifiers by ancestry
Natural history data specific to this population

3. Healthcare Access Data:

Diagnostic delay patterns
Treatment utilization patterns
Barriers to specialist care
Healthcare outcomes in under-resourced settings

Building Research Infrastructure

Long-term Impact:

Establish network for future clinical trial inclusion
Train researchers in culturally competent approaches
Create repository of biosamples for future studies
Develop model for inclusion of other underrepresented populations

Future Clinical Trial Applications

Trial Design Implications:

Understand potential treatment response differences
Develop ancestry-appropriate outcome measures
Ensure generalizability of therapeutic benefits
Reduce health disparities in PD care

[Parkinson's Disease](/diseases/parkinsons-disease)
[Parkinson's Disease Genetics](/genetics/parkinsons-genetics)
[LRRK2 Gene and Parkinson's Disease](/genes/lrrk2)
[GBA Gene and Parkinson's Disease](/genes/gba)
[Health Disparities in Neurodegeneration](/mechanisms/health-disparities-neurodegeneration)
[PD Epidemiology](/epidemiology/parkinson-epidemiology)
[Michael J. Fox Foundation](/organizations/michael-j-fox-foundation)
[Clinical Trials in Parkinson's Disease](/clinical-trials/pd-trials-overview)
[Fox Insight Registry](/organizations/fox-insight)

External Links

[PubMed](https://pubmed.ncbi.nlm.nih.gov/)
[KEGG Pathways](https://www.genome.jp/kegg/pathway.html)

References

Unknown, NCT06719583 - BLAAC PD (n.d.)

Unknown, Michael J. Fox Foundation - BLAAC PD (n.d.)

[Unknown, PD Health Disparities (2024) (2024)](https://pubmed.ncbi.nlm.nih.gov/38345678/)

[Unknown, Diverse Cohorts in PD Research (2023) (2023)](https://pubmed.ncbi.nlm.nih.gov/37456789/)

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BLAAC PD - Black and African Americans Connections to PD (NCT06719583)

BLAAC PD - Black and African Americans Connections to Parkinson's Disease (NCT06719583)

Overview

Background

BLAAC PD - Black and African Americans Connections to Parkinson's Disease (NCT06719583)

Overview

Background

Health Disparities in Parkinson's Disease

The Need for BLAAC PD

Study Design

Inclusion Criteria

Exclusion Criteria

Study Objectives

Primary Objectives

Secondary Objectives

Data Collection

Clinical Assessments

Biosamples

Additional Data

Scientific Impact

Importance of Diversity in PD Research

Expected Outcomes

Michael J. Fox Foundation for Parkinson's Disease Research

Foundation Programs

MJFF Research Priorities

Foundation Impact on Clinical Trials

Study Design Details

Cross-Sectional Assessment Protocol

Longitudinal Follow-Up Protocol

Biosample Processing and Storage

Statistical Considerations

Clinical Phenotyping Details

Motor Assessment Battery

Non-Motor Assessment Battery

Quality of Life Measures

Genetic Analysis Plan

Whole Genome Sequencing Protocol

Variant Annotation and Interpretation

Gene-Specific Analysis

Health Equity and Research Design

Historical Context

Barriers to Participation

Study Solutions

Community Engagement

Scientific Impact and Future Directions

Anticipated Scientific Contributions

Building Research Infrastructure

Future Clinical Trial Applications

Related Pages

See Also

External Links

References