Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy (TBI and CTE)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT02003183
First received: November 5, 2013
Last updated: December 2, 2013
Last verified: December 2013
  Purpose

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

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: FDDNP-PET Imaging in Persons at Risk for Chronic Traumatic Encephalopathy

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • FDDNP PET will detect tau deposits in the brain of living subjects at risk for CTE [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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:
  • Correlation of genetic risk factors and FDDNP-PET measurements [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    FDDNP-PET measures will vary according to genotypes found to influence age at dementia onset (e.g., apolipoprotein E [APOE]).


Other Outcome Measures:
  • Cognitive Impairment will be observed in subjects at risk of CTE [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Affected subjects will show greater depressive symptoms than controls as well as cognitive impairment.


Estimated Enrollment: 50
Study Start Date: March 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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  Eligibility

Ages Eligible for Study:   30 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02003183

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

Additional Information:
Publications:

Responsible Party: Gary Small, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02003183     History of Changes
Other Study ID Numbers: 11-001077, IND 74944
Study First Received: November 5, 2013
Last Updated: December 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of California, Los Angeles:
CTE
TBI
Cognitive Impairment
Brain Imaging
PET

Additional relevant MeSH terms:
Brain Injury, Chronic
Brain Injuries
Cognition Disorders
Mild Cognitive Impairment
Brain Diseases
Dementia
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Brain Damage, Chronic

ClinicalTrials.gov processed this record on October 19, 2014