The DIAGNOSE-CTE Research Project

NCT02798185 | Completed

• 2 other identifiers: H-34799U01NS093334
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

This is a study to develop methods of diagnosing chronic traumatic encephalopathy (CTE) during life, as well as to examine possible risk factors for this neurodegenerative disease. One component of this study is the use of an investigational PET scan radio tracer to detect abnormal tau protein in the brain.

Conditions

Chronic Traumatic Encephalopathy

Outcome Measures

Primary Outcomes (7)

• Neuroimaging Positron Emission Tomography for Amyloid Biomarker

  Subjects will undergo a Florbetapir Positron Emission Tomography (PET) scan. The Outcome Measurement for the Florbetapir PET Scan will be "elevated" or "not elevated"

  One-Time

• Fluid Biomarkers

  The following Biospecimens will be collected from subjects: Saliva, blood and cerebral spinal fluid (CSF). CSF will be collected by a lumbar puncture (spinal tap) Fluid biomarkers will be analyzed for the in vivo detection of CTE.

  3 Years

• Neuropsychiatric and Neurocognitive Tests

  Composite scores (presented as z scores) based on factor analytic methodology in the following domains: * Mood * Behavior Regulation * Attention, Information Processing and Psychomotor Speed * Executive Functioning * Verbal Memory * Visual Memory * Visual-Spatial Ability * Language

  3 years

• Neurological Evaluation

  Subjects will undergo The Movement Disorder Society's Unified Parkinson's Disorders Rating Scale (MDS-UPDRS) Neurological Evaluation by a physician. This evaluation will be analyzed to characterize the clinical presentation of CTE.

  3 years

• Magnetic Resonance Imagining Biomarkers

  Subjects will undergo Diffuser Tension Imaging (dti) and Functional MRI scans, to assess structural brain volumetrics, fractional anisotropy, radial diffusivity, and changes in brain activity associated with blood flow.

  3 years

• Neuroimaging Positron Emission Tomography for Tau Biomarker

  Subjects will undergo an Investigational drug: AV1451 Positron Emission Tomography (PET) scan. The Outcome Measurement for AV1451 PET scan will be Standardized Uptake Value Ratio (SUVR) of Tau.

  3 years

• Magnetic Resonance Spectroscopy Biomarkers

  Subject will also undergo Magnetic Resonance Spectroscopy (MRS) to measure glutamate, glutamine and myoinosotol.

  3 years

Study Arms (3)

Former NFL Players

120 former National Football League players with and without reported cognitive, mood and behavior symptoms will be enrolled in this study.

Former College Football Players

60 former college football players with and without reported cognitive, mood and behavior symptoms will be enrolled in this study.

Control Group

60 asymptomatic same-age men without any history of participation in contact sports, military service, or traumatic brain injury will be enrolled in this study.

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Former National Football League Players, Former Varsity Level College Football Players, Healthy Controls

You may qualify if:

• Former NFL Players:
• English as primary language
• No MRI or Lumbar Puncture (LP) contraindications
• Have played ≥12 years of organized football (including =\>3 in college and =\>3 seasons in the NFL)
• Must have played one of following positions offensive lineman, defensive lineman, linebacker, tight end, wide receiver, running back, or defensive back.
• Agree to provide name and contact information of a study partner who will complete questionnaires regarding subject's mood, behavior, thinking and cognitive function should the subject enroll in the study.
• Former Collegiate Football Players
• English as primary language
• No MRI or Lumbar Puncture (LP) contraindications
• Must have played =\>6 years of organized football (with =\> 3 years at the college level, but no organized football or other contact sport following college.)
• Must have played one of following positions offensive lineman, defensive lineman, linebacker, tight end, wide receiver, running back, or defensive back.
• No military service
• Agree to provide name and contact information of a study partner who will complete questionnaires regarding subject's mood, behavior, thinking and cognitive function should the subject enroll in the study.
• Control Group
• English as primary language

You may not qualify if:

• If they have a history of clinical stroke confirmed on neuroimaging
• If they have vision or hearing impairment significant enough to compromise neuropsychological testing
• If they have been hospitalized or treated in an emergency room following a severe injury to their head since they stopped playing football
• If they are unable to undergo MRI/PET Scan
• If they have a spinal fusion at L3-4 and/or L4-5
• If they are unable to travel to one of 4 study sites to participate
• If they are an insulin dependent diabetic
• If they cannot provide the name and contact information of an eligible study partner
• If they are taking blood thinners that would make LP unsafe
• If they have a type of abnormal heart rhythm called Torsades de pointes AKA TdP
• If they have an abnormal heart rhythm disorder called QT Prolongation or take certain medications known to cause QT Prolongation
• If they do not agree to all study tests and procedures
• If they are unable to consent to study procedures
• If they have vision or hearing impairment significant enough to compromise neuropsychological testing
• If they are unable to undergo MRI/PET Scan

Sponsors & Collaborators

• Boston University: lead
• Mayo Clinic: collaborator
• Banner Health: collaborator
• Brigham and Women's Hospital: collaborator
• NYU Langone Health: collaborator
• The Cleveland Clinic: collaborator
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Boston University School of Medicine

Boston, Massachusetts, 02118, United States

Location

Related Publications (3)

• Su Y, Protas H, Luo J, Chen K, Alosco ML, Adler CH, Balcer LJ, Bernick C, Au R, Banks SJ, Barr WB, Coleman MJ, Dodick DW, Katz DI, Marek KL, McClean MD, McKee AC, Mez J, Daneshvar DH, Palmisano JN, Peskind ER, Turner RW 2nd, Wethe JV, Rabinovici G, Johnson K, Tripodis Y, Cummings JL, Shenton ME, Stern RA, Reiman EM; DIAGNOSE CTE Research Project Investigators. Flortaucipir tau PET findings from former professional and college American football players in the DIAGNOSE CTE research project. Alzheimers Dement. 2024 Mar;20(3):1827-1838. doi: 10.1002/alz.13602. Epub 2023 Dec 22.

  PMID: 38134231 DERIVED

• Stern RA, Trujillo-Rodriguez D, Tripodis Y, Pulukuri SV, Alosco ML, Adler CH, Balcer LJ, Bernick C, Baucom Z, Marek KL, McClean MD, Johnson KA, McKee AC, Stein TD, Mez J, Palmisano JN, Cummings JL, Shenton ME, Reiman EM; DIAGNOSE CTE Research Project Investigators. Amyloid PET across the cognitive spectrum in former professional and college American football players: findings from the DIAGNOSE CTE Research Project. Alzheimers Res Ther. 2023 Oct 5;15(1):166. doi: 10.1186/s13195-023-01315-5.

  PMID: 37798671 DERIVED

• Alosco ML, Mariani ML, Adler CH, Balcer LJ, Bernick C, Au R, Banks SJ, Barr WB, Bouix S, Cantu RC, Coleman MJ, Dodick DW, Farrer LA, Geda YE, Katz DI, Koerte IK, Kowall NW, Lin AP, Marcus DS, Marek KL, McClean MD, McKee AC, Mez J, Palmisano JN, Peskind ER, Tripodis Y, Turner RW 2nd, Wethe JV, Cummings JL, Reiman EM, Shenton ME, Stern RA; DIAGNOSE CTE Research Project Investigators. Developing methods to detect and diagnose chronic traumatic encephalopathy during life: rationale, design, and methodology for the DIAGNOSE CTE Research Project. Alzheimers Res Ther. 2021 Aug 12;13(1):136. doi: 10.1186/s13195-021-00872-x.

  PMID: 34384490 DERIVED

Related Links

• Study website

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen samples to be collected include: saliva, blood and cerebral spinal fluid (CSF)

MeSH Terms

Conditions

Chronic Traumatic Encephalopathy

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Injury, Chronic; Neurodegenerative Diseases; Craniocerebral Trauma; Trauma, Nervous System; Brain Damage, Chronic; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Wounds and Injuries

Study Officials

• Robert A Stern, PhD

  Boston University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2016
• First Posted: June 14, 2016
• Study Start: August 1, 2016
• Primary Completion: October 31, 2023
• Study Completion: November 15, 2023
• Last Updated: December 5, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share

Locations

US (1)