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University of Pittsburgh Brain Health Initiative (BHI)

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ClinicalTrials.gov Identifier: NCT04708613
Recruitment Status : Recruiting
First Posted : January 14, 2021
Last Update Posted : January 14, 2021
Sponsor:
Collaborators:
National Football League Scientific Advisory Board
Avid Radiopharmaceuticals, Inc.
Harvard University
Information provided by (Responsible Party):
David Okonkwo, MD, PhD, University of Pittsburgh

Tracking Information
First Submitted Date January 5, 2021
First Posted Date January 14, 2021
Last Update Posted Date January 14, 2021
Actual Study Start Date November 18, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 13, 2021)
Rates of Brain Health versus Cognitive Impairment [ Time Frame: 1-week ]
The diagnosis of cognitive impairment is based on the ADRC National Alzheimer's Coordinating Center (NACC) criteria for mild cognitive impairment. This criteria is adjudicated following a comprehensive neuropsychological exam, and includes: (1) Self- or informant-reported cognitive complaint, (2) Objective cognitive impairment, (3) Preserved independence in functional abilities, and (4) No dementia.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: January 13, 2021)
Clinical Syndromes of Neurodegeneration [ Time Frame: 1-week ]
The determination of trauma-related neurodegeneration will be based on: 1) presence of cognitive deficits, and/or neuromotor manifestations, and/or behavioral/mood-related symptoms; 2) PET scans demonstrating abnormal amyloid and/or tau deposition; 3) quantitative MR evidence of cortical volume loss and/or white matter injury; and 4) elevated CSF tau/Aβ42 ratio. These multiple measures will be combined to arrive at a single overall outcome measure. This will be adjudicated at a blinded Diagnostic Consensus Conference comprised of experts from each field.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title University of Pittsburgh Brain Health Initiative
Official Title Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players
Brief Summary This project will define the prevalence of brain health (i.e., normal cognitive, neuromotor, behavioral function) in living professional football retirees and group-matched controls through a comprehensive assessment of clinical, neuroimaging, and biomarker measures.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population
  1. Professional Football Players:

    There will be 2 cohorts of former professional football players in this group: (a) random sample, and (b) non-random sample.

    1. Random-Sample participants

      Recruitment of random-sample former professional football players will be conducted via collaboration with the Football Players Health Study (FPHS) at Harvard University. Subjects for the Brain Health Initiative (BHI) will include a random sample of enrollees in the FPHS who meet basic eligibility for BHI.

    2. Non-Random participants:

    We will also enroll a non-random cohort of former professional football players that will be comprised of volunteers.

  2. Controls:

There will be 3 cohorts of unexposed controls in this group: (a) friends of former players, (b) brothers or former players, and (c) general population. Football players will be invited to refer friend(s) and/or brother(s), but it is not required for participation.

Condition Traumatic Brain Injury
Intervention
  • Diagnostic Test: Cognitive/Neuropsychological Testing
    Comprehensive testing of cognitive function and brain health.
  • Diagnostic Test: Vestibular/Ocular-Motor Testing
    A series of tests and questionnaires that asses vestibular function, balance, ocular-motor coordination, and reflexes.
  • Diagnostic Test: Sleep Evaluation
    A full assessment of sleep health, including insomnia (duration, frequency, daytime consequences) and other sleep disorders such as obstructive sleep apnea. Overnight sleep study is included.
  • Diagnostic Test: MRI, High-Resolution
    A high-resolution MRI to provide qualitative and quantitative assessments of brain structure.
  • Diagnostic Test: Health & Physical Exam
    Participants will undergo an executive history and physical exam of all body systems.
  • Diagnostic Test: Physical Function
    These assessments will involve a series of tests and questionnaires that focus on physical function.
  • Diagnostic Test: Blood Testing and Biomarker Analysis

    A blood draw will be performed to measure standard clinical labs as part of a full history and physical, as well as additional analysis of biomarkers indicative of brain health.

    An optional lumbar puncture will be performed and CSF samples (20-30 mL) stored in the NCTC Biorepository until shipment to the CLIA-certified laboratory.

    Both CSF and blood samples will be analyzed for t-tau, p-tau, and Aβ42 and stored for future testing,

  • Diagnostic Test: Applanation Tonometry
    Hearth health is evaluated through testing of arterial stiffness and pulse wave reflections using a high fidelity applanation tonometer.
    Other Name: Continuous arterial pressure
  • Diagnostic Test: PET brain imaging
    PET imaging of the brain using tau and amyloid ligands.
  • Drug: [C-11]6-OH-BTA-1
    PET imaging of the brain using an amyloid ligand.
    Other Name: Pittsburgh Compound B
  • Drug: [F-18]AV-1451
    PET imaging of the brain using a tau ligand.
    Other Name: [F-18]T807, LY3191748
Study Groups/Cohorts
  • Former Professional Football Players
    Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.
    Interventions:
    • Diagnostic Test: Cognitive/Neuropsychological Testing
    • Diagnostic Test: Vestibular/Ocular-Motor Testing
    • Diagnostic Test: Sleep Evaluation
    • Diagnostic Test: MRI, High-Resolution
    • Diagnostic Test: Health & Physical Exam
    • Diagnostic Test: Physical Function
    • Diagnostic Test: Blood Testing and Biomarker Analysis
    • Diagnostic Test: Applanation Tonometry
    • Diagnostic Test: PET brain imaging
    • Drug: [C-11]6-OH-BTA-1
    • Drug: [F-18]AV-1451
  • Control Groups
    Friends and brothers of the Former Professional Football Player group.
    Interventions:
    • Diagnostic Test: Cognitive/Neuropsychological Testing
    • Diagnostic Test: Vestibular/Ocular-Motor Testing
    • Diagnostic Test: Sleep Evaluation
    • Diagnostic Test: MRI, High-Resolution
    • Diagnostic Test: Health & Physical Exam
    • Diagnostic Test: Physical Function
    • Diagnostic Test: Blood Testing and Biomarker Analysis
    • Diagnostic Test: Applanation Tonometry
    • Diagnostic Test: PET brain imaging
    • Drug: [C-11]6-OH-BTA-1
    • Drug: [F-18]AV-1451
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 13, 2021)
300
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion criteria:

Former professional football player/exposed group:

  1. Professional football retiree aged 29-59
  2. Played a minimum of 3 professional football seasons, with a minimum of 3 games in each season

Control/unexposed group:

  1. Age 29-59 male
  2. High school education or beyond

Exclusion criteria:

Control/unexposed group:

  1. Played organized football beyond high school
  2. History of severe TBI
  3. Current unstable cardiovascular disorder

For both groups:

  1. Prior history of psychosis (such as schizophrenia), or other major neurological disorder that would interfere with testing, in the opinion of the primary investigator.
  2. Contraindication to MR imaging, such as ferrous metal, pacemakers, or concerns about claustrophobia
  3. Non-native English speakers (translations are not available/validated for most neuropsychological tests)
Sex/Gender
Sexes Eligible for Study: Male
Gender Based Eligibility: Yes
Gender Eligibility Description: Females will not be included in the study population. Participants will be prior professional football players, age 29-59, that are eligible for a pension. Control participants will be group-matched for age and gender and therefore females will not be included in the study population.
Ages 29 Years to 59 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Kathryn L Edelman, MS 412-624-1077 dunfeekl@upmc.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04708613
Other Study ID Numbers Brain Health Initiative
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party David Okonkwo, MD, PhD, University of Pittsburgh
Study Sponsor David Okonkwo, MD, PhD
Collaborators
  • National Football League Scientific Advisory Board
  • Avid Radiopharmaceuticals, Inc.
  • Harvard University
Investigators
Principal Investigator: David O Okonkwo, MD, PhD University of Pittsburgh Department of Neurological Surgery
PRS Account University of Pittsburgh
Verification Date January 2021