Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy

Completed

Conditions studied: CTE, TBI (Traumatic Brain Injury)

In brief

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.

Key facts

Study ID

NCT02003183

Run by

University of California, Los Angeles

People needed

24

Starts

2013-03-01

Expected to finish

2018-12-01

Last updated by the study team

2020-03-03

Who can join

Age: 18 and older, up to 90. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA Division of Geriatric Psychiatry, Semel Institute — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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