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Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy

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: NCT02003183
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : November 27, 2019
Last Update Posted : March 3, 2020
Sponsor:
Information provided by (Responsible Party):
Gary Small, MD, University of California, Los Angeles

Brief Summary:
This project was designed to determine brain imaging patterns using 2-(1-{6-[(2-fluorine 18-labeled fluoroethyl)methylamino]-2-naphthyl}ethylidene)malononitrile ([F-18]FDDNP) with positron emission tomography (PET) in participants with suspected Chronic Traumatic Encephalopathy (CTE), a progressive degenerative disease of the brain found in people with a history of repetitive traumatic brain injuries (TBIs), characterized by personality, behavioral, and mood disturbances, cognitive impairment, and sometimes motor symptoms. Currently, CTE can only be definitely diagnosed from neuropathological examination of the brain after autopsy. Developing tools to assist in the detection of this condition in living individuals at risk would facilitate research focusing on discovering potential prevention and treatment strategies.

Condition or disease Intervention/treatment
CTE TBI (Traumatic Brain Injury) Radiation: [F-18]FDDNP

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Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: FDDNP-PET Imaging in Persons at Risk for Chronic Traumatic Encephalopathy
Actual Study Start Date : March 2013
Actual Primary Completion Date : October 2018
Actual Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Suspected CTE
A total of 22 participants with suspected CTE were studied. Each received clinical and neuropsychological assessments, [F-18]FDDNP-PET scans, and magnetic resonance imaging (MRI) scans, or computed tomography scans if they could not tolerate MRI (to assist in PET region of interest identification).
Radiation: [F-18]FDDNP
Each participant was injected with [F-18]FDDNP, a radiolabeled molecular imaging probe, prior to receiving a PET scan.




Primary Outcome Measures :
  1. Distribution Volume Ratio (DVR) [ Time Frame: Baseline ]
    The outcome measure is a ratio of the volume (in milliliters) of 2-(1-{6-[(2-fluorine 18-labeled fluoroethyl)methylamino]-2-naphthyl}ethylidene)malononitrile ([F-18]FDDNP) bound within the region of interest (ROI) divided by the amount of [F-18]FDDNP in the cerebellum (reference region). Higher ratios are indicative of higher levels of tau and amyloid proteins within the ROI. The unit of measure is called the Distribution Volume Ratio (DVR).


Biospecimen Retention:   None Retained
Samples are being stored


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Military personnel and retired football players were exclusively men, whereas the comparative groups (AD, cognitively healthy controls) had a substantial proportion of women. Military personnel were significantly younger than the other three groups. Four of the seven military personnel were cognitively normal, and three had mild cognitive impairment. While the difference in education levels among participant groups did not reach statistical significance, pairwise comparisons indicated that military personnel had significantly lower education levels than both players and cognitively healthy individuals. Military personnel and players had significantly higher levels of depression and anxiety than did the comparison groups.
Criteria

Inclusion Criteria:

  1. Agreement to participate in study;
  2. A history of TBI resulting from, but not limited to, any of the following: contact sports, accidents, violence, or military combat;
  3. Age 18 or older;
  4. No significant cerebrovascular disease;
  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 neurological 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 blood pressure > 170 or diastolic blood pressure > 100),
  4. History of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer.
  5. Such current major psychiatric disorders as mania within the previous two years.
  6. Participants taking drugs that are known to affect [F-18]FDDNP-PET binding (e.g., ibuprofen, naproxen) were 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, depending on drug half-life.

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 ClinicalTrials.gov identifier (NCT number): NCT02003183


Locations
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United States, California
UCLA Division of Geriatric Psychiatry, Semel Institute
Los Angeles, California, United States, 90095
Sponsors and Collaborators
University of California, Los Angeles
Investigators
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Principal Investigator: Gary W Small, M.D. UCLA Division of Geriatric Psychiatry
  Study Documents (Full-Text)

Documents provided by Gary Small, MD, University of California, Los Angeles:
Publications of Results:
Other Publications:

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Responsible Party: Gary Small, MD, Principal Investigator, University of California, Los Angeles
ClinicalTrials.gov Identifier: NCT02003183    
Other Study ID Numbers: 11-001077
IND 74944 ( Other Identifier: FDA )
First Posted: December 6, 2013    Key Record Dates
Results First Posted: November 27, 2019
Last Update Posted: March 3, 2020
Last Verified: February 2020
Keywords provided by Gary Small, MD, University of California, Los Angeles:
Chronic Traumatic Encephalopathy
Traumatic Brain Injury
Cognitive Impairment
Positron Emission Tomography
[F-18]FDDNP
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Chronic Traumatic Encephalopathy
Wounds and Injuries
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Brain Injury, Chronic
Neurodegenerative Diseases