Clinical Trial: The DIAGNOSE-CTE Research Project

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Diagnostics, Imaging And Genetics Network for the Objective Study and Evaluation of Chronic Traumatic Encephalopathy (DIAGNOSE CTE) Research Project

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. Once component of this study is the use of an investigational PET scan radio tracer to detect abnormal tau protein in the brain.

Detailed Summary:

Chronic Traumatic Encephalopathy (CTE) is a neurodegenerative disease characterized by a distinct deposition of phosphorylated tau (p-tau) in neurons and astrocytes in a pattern that is unique from other tauopathies, including Alzheimer's disease (AD). Although the neuropathological features of CTE have become further clarified in recent years, the clinical presentation of CTE is still not well characterized. Diagnostic criteria have only recently been published and lack validation.

Neuroimaging and fluid biomarkers developed for the diagnosis of other neurodegenerative diseases have only been used in preliminary studies of individuals at high risk for CTE, namely athletes with histories of significant exposure to repetitive head impacts (RHI), such as former football players and boxers. There is thus an urgent need to develop accurate methods for detecting and diagnosing CTE during life so that effective interventions for prevention and treatment can be developed. Moreover, though a history of RHI is a necessary risk factor for CTE, it alone is not sufficient. There is a need to understand what specific aspects of RHI exposure places an individual at increased risk for CTE and to examine potential genetic polymorphisms that modify that risk.

To address these needs, the investigators are conducting a multidisciplinary, multicenter, longitudinal study of former NFL and varsity college football players (with and without symptoms), and a control group of asymptomatic same-age men without any history of RHI exposure, traumatic brain injury or military service. Subjects will be seen at 1 of 4 participating study sites in Boston; Las Vegas, ; New York; and Scottsdale/Phoenix . Subjects will undergo a baseline evaluation and a 3 year follow-up evaluation (currently former college players will not complete the follow-up evaluation
Sponsor: Boston University

Current Primary Outcome:

  • Neuroimaging Positron Emission Tomography for Amyloid Biomarker [ Time Frame: One-Time ]

    Subjects will undergo a Florbetapir Positron Emission Tomography (PET) scan.

    The Outcome Measurement for the Florbetapir PET Scan will be "elevated" or "not elevated"

  • Fluid Biomarkers [ Time Frame: 3 Years ]

    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.

  • Neuropsychiatric and Neurocognitive Tests [ Time Frame: 3 years ]

    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
  • Neurological Evaluation [ Time Frame: 3 years ]
    Subjects will undergo The Movement Di

    Original Primary Outcome: Same as current

    Current Secondary Outcome:

    Original Secondary Outcome:

    Information By: Boston University

    Dates:
    Date Received: May 20, 2016
    Date Started: August 2016
    Date Completion: July 2023
    Last Updated: August 15, 2016
    Last Verified: August 2016