Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy
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ClinicalTrials.gov Identifier: NCT02003183 |
Recruitment Status :
Completed
First Posted : December 6, 2013
Results First Posted : November 27, 2019
Last Update Posted : March 3, 2020
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Condition or disease | Intervention/treatment |
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CTE TBI (Traumatic Brain Injury) | Radiation: [F-18]FDDNP |

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 |

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).
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Radiation: [F-18]FDDNP
Each participant was injected with [F-18]FDDNP, a radiolabeled molecular imaging probe, prior to receiving a PET scan. |
- 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

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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 |
Inclusion Criteria:
- Agreement to participate in study;
- A history of TBI resulting from, but not limited to, any of the following: contact sports, accidents, violence, or military combat;
- Age 18 or older;
- No significant cerebrovascular disease;
- Adequate visual and auditory acuity to allow neuropsychological testing;
- Screening laboratory tests without significant abnormalities that might interfere with the study.
Exclusion Criteria:
- Preexisting major neurological or other physical illness that could confound results (e.g., multiple sclerosis, diabetes, cancer);
- History of myocardial infarction within the previous year or unstable cardiac disease.
- Uncontrolled hypertension (systolic blood pressure > 170 or diastolic blood pressure > 100),
- History of significant liver disease, clinically significant pulmonary disease, diabetes, or cancer.
- Such current major psychiatric disorders as mania within the previous two years.
- 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.
- Use of any investigational drugs within the previous month, depending on drug half-life.

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 Division of Geriatric Psychiatry, Semel Institute | |
Los Angeles, California, United States, 90095 |
Principal Investigator: | Gary W Small, M.D. | UCLA Division of Geriatric Psychiatry |
Documents provided by Gary Small, MD, University of California, Los Angeles:
Other Publications:
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 |
Chronic Traumatic Encephalopathy Traumatic Brain Injury Cognitive Impairment Positron Emission Tomography [F-18]FDDNP |
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 |