The DIAGNOSE-CTE Research Project (DIAGNOSE-CTE)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02798185|
Recruitment Status : Active, not recruiting
First Posted : June 14, 2016
Last Update Posted : March 16, 2021
|Condition or disease|
|Chronic Traumatic Encephalopathy|
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). Each evaluation will be take place over a 3 day period and consist of the following procedures/tests: neurocognitive testing, determination of functional independence, neuropsychiatric examination (with measures of mood and behavior), neurological assessment (motor, headache, postural stability), neuroimaging (including structural, diffusion, functional, biochemical, and molecular imaging), lumbar punctures (for Cerebrospinal Fluid (CSF) biomarkers), blood draws (for blood biomarkers and DNA), and saliva samples (for biomarkers).
|Study Type :||Observational|
|Actual Enrollment :||240 participants|
|Official Title:||Diagnostics, Imaging And Genetics Network for the Objective Study and Evaluation of Chronic Traumatic Encephalopathy (DIAGNOSE CTE) Research Project|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||July 2023|
|Estimated Study Completion Date :||July 2023|
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.
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.
- 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:
- Behavior Regulation
- Attention, Information Processing and Psychomotor Speed
- Executive Functioning
- Verbal Memory
- Visual Memory
- Visual-Spatial Ability
- Neurological Evaluation [ Time Frame: 3 years ]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.
- Magnetic Resonance Imagining Biomarkers [ Time Frame: 3 years ]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.
- Neuroimaging Positron Emission Tomography for Tau Biomarker [ Time Frame: 3 years ]
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.
- Magnetic Resonance Spectroscopy Biomarkers [ Time Frame: 3 years ]Subject will also undergo Magnetic Resonance Spectroscopy (MRS) to measure glutamate, glutamine and myoinosotol.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02798185
|United States, Massachusetts|
|Boston University School of Medicine|
|Boston, Massachusetts, United States, 02118|
|Principal Investigator:||Robert A Stern, PhD||Boston University|