Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy (TBI and CTE)
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|ClinicalTrials.gov Identifier: NCT02003183|
Recruitment Status : Active, not recruiting
First Posted : December 6, 2013
Last Update Posted : October 16, 2018
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|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
[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.
- 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.
- 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]).
- 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.
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
|United States, California|
|UCLA Longevity Center|
|Los Angeles, California, United States, 90095|
|Principal Investigator:||Gary W Small, M.D.||UCLA Longevity Center|