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Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy (TBI and 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. Identifier: NCT02003183
Recruitment Status : Active, not recruiting
First Posted : December 6, 2013
Last Update Posted : October 16, 2018
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles

Brief Summary:

The project is designed to assess early diagnosis of Chronic Traumatic Encephalopathy (CTE), a neurobehavioral syndrome manifested by failed relationships, marriages, and businesses, emotional disturbances, depression, alcohol and substance abuse, and suicide attempts and completions. CTE typically begins after a latency period of several years following single or repeated Traumatic Brain Injuries (TBIs). A history of cerebral concussion may or may not be present.

This study builds upon prior work at UCLA using Positron Emission Tomography (PET) to identify normal and abnormal functional patterns in the brain by studying persons with a history of TBI including but not limited to: amateur and professional athletes, active and veteran members of the armed forces, as well as victims of motor vehicle and work accidents, and physical battery/domestic violence.

This project aims to expand these findings to the population at large. Identification of the syndrome is critical for identifying potential individuals who are most likely to benefit from potential prevention and treatment.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Chronic Traumatic Encephalopathy Concussions Mild Cognitive Impairment Radiation: [F-18]FDDNP Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: FDDNP-PET Imaging in Persons at Risk for Chronic Traumatic Encephalopathy
Study Start Date : March 2013
Actual Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: [F-18]FDDNP Radiation: [F-18]FDDNP
[F-18]FDDNP is a molecular imaging probe for PET, with high in vitro binding affinity to NFTs and of the fibrillar tau deposits as shown with fluorescent microscopy with non-radioactive FDDNP.

Primary Outcome Measures :
  1. FDDNP PET will detect tau deposits in the brain of living subjects at risk for CTE [ Time Frame: Baseline ]
    FDDNP signals will be higher in those affected by CTE compared with controls in all subcortical regions and the amygdala areas that produce tau deposits following trauma.

Secondary Outcome Measures :
  1. Correlation of genetic risk factors and FDDNP-PET measurements [ Time Frame: Baseline ]
    FDDNP-PET measures will vary according to genotypes found to influence age at dementia onset (e.g., apolipoprotein E [APOE]).

Other Outcome Measures:
  1. Cognitive Impairment will be observed in subjects at risk of CTE [ Time Frame: Baseline ]
    Affected subjects will show greater depressive symptoms than controls as well as cognitive impairment.

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  1. Agreement to participate in study
  2. A history of Traumatic Brain Injury resulting from, but not limited to, any of the following: sports, accidents, violence, and military combat.
  3. Age 18 or older
  4. No significant cerebrovascular disease - modified Ischemic Score of ≤ 8 (Rosen et al, 1980)
  5. Adequate visual and auditory acuity to allow neuropsychological testing.
  6. Screening laboratory tests without significant abnormalities that might interfere with the study

Exclusion Criteria:

  1. Preexisting major neurologic or other physical illness that could confound results (e.g., multiple sclerosis, diabetes, cancer);
  2. History of myocardial infarction within the previous year or unstable cardiac disease.
  3. Uncontrolled hypertension (systolic BP > 170 or diastolic BP > 100),
  4. History of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer.
  5. Such current major psychiatric disorders as mania, according to DSM-IV TR criteria, within the previous two years (APA, 2000).
  6. Subjects taking drugs that are known to affect FDDNP-PET binding (e.g., ibuprofen, naproxen) will be asked to stop taking medication one week prior to PET scan or excluded from the study.
  7. Use of any investigational drugs within the previous month or longer, depending on drug half-life will exclude subjects.

Information from the National Library of Medicine

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 identifier (NCT number): NCT02003183

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United States, California
UCLA Longevity Center
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
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Principal Investigator: Gary W Small, M.D. UCLA Longevity Center

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Gary Small, MD, Principal Investigator, University of California, Los Angeles Identifier: NCT02003183     History of Changes
Other Study ID Numbers: 11-001077
IND 74944
First Posted: December 6, 2013    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
Keywords provided by Gary Small, MD, University of California, Los Angeles:
Cognitive Impairment
Brain Imaging
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Chronic Traumatic Encephalopathy
Cognitive Dysfunction
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Brain Injury, Chronic
Neurodegenerative Diseases