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Clinical Trials/NCT04708613
NCT04708613
Recruiting
Not Applicable

Prevalence of Brain Health Versus Neurodegeneration in Former Professional Football Players

David Okonkwo, MD, PhD1 site in 1 country300 target enrollmentStarted: November 18, 2019Last updated:

Overview

Phase
Not Applicable
Status
Recruiting
Sponsor
David Okonkwo, MD, PhD
Enrollment
300
Locations
1
Primary Endpoint
Rates of Brain Health versus Cognitive Impairment

Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
29 Years to 59 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: Cognitive/Neuropsychological Testing (Diagnostic Test)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: Vestibular/Ocular-Motor Testing (Diagnostic Test)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: Sleep Evaluation (Diagnostic Test)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: MRI, High-Resolution (Diagnostic Test)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: Health & Physical Exam (Diagnostic Test)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: Health & Physical Exam (Diagnostic Test)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: Physical Function (Diagnostic Test)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: Blood Testing and Biomarker Analysis (Diagnostic Test)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: Applanation Tonometry (Diagnostic Test)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: PET brain imaging (Diagnostic Test)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: [C-11]6-OH-BTA-1 (Drug)

Former Professional Football Players

Former professional football players who played in at least 3 professional seasons, with at least 3 games each season.

Intervention: [F-18]AV-1451 (Drug)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: Cognitive/Neuropsychological Testing (Diagnostic Test)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: Vestibular/Ocular-Motor Testing (Diagnostic Test)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: Sleep Evaluation (Diagnostic Test)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: MRI, High-Resolution (Diagnostic Test)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: Physical Function (Diagnostic Test)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: Blood Testing and Biomarker Analysis (Diagnostic Test)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: Applanation Tonometry (Diagnostic Test)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: PET brain imaging (Diagnostic Test)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: [C-11]6-OH-BTA-1 (Drug)

Control Groups

Friends and brothers of the Former Professional Football Player group.

Intervention: [F-18]AV-1451 (Drug)

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Clinical Syndromes of Neurodegeneration(1-week)

Investigators

Sponsor
David Okonkwo, MD, PhD
Sponsor Class
Other
Responsible Party
Sponsor Investigator
Principal Investigator

David Okonkwo, MD, PhD

Professor

University of Pittsburgh

Study Sites (1)

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