N/A
N=24
Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy
CTE · TBI (Traumatic Brain Injury)
Bottom Line
View on ClinicalTrials.gov: NCT02003183 ↗Enrolled (actual)
24
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Distribution Volume Ratio (DVR) — 1.30; 1.39; 1.26; 1.34 Distribution Volume Ratio (DVR) — p=<0.02
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- [F-18]FDDNP (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of California, Los Angeles
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Distribution Volume Ratio (DVR) |
1.30; 1.39; 1.26; 1.34; 1.32; 1.42 | <0.02 sig |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02003183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.