Trial Outcomes & Findings for Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy (NCT NCT02003183)
NCT ID: NCT02003183
Last Updated: 2020-03-03
Results Overview
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).
COMPLETED
24 participants
Baseline
2020-03-03
Participant Flow
Participant milestones
| Measure |
Military Personnel
Military personnel with suspected chronic traumatic encephalopathy (CTE), each with a history of head trauma and cognitive or mood symptoms.
|
Players
Retired football players with suspected CTE, each with a history of head trauma and cognitive or mood symptoms.
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
17
|
|
Overall Study
COMPLETED
|
7
|
15
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Military Personnel
Military personnel with suspected chronic traumatic encephalopathy (CTE), each with a history of head trauma and cognitive or mood symptoms.
|
Players
Retired football players with suspected CTE, each with a history of head trauma and cognitive or mood symptoms.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Traumatic Brain Injury and Risk for Chronic Traumatic Encephalopathy
Baseline characteristics by cohort
| Measure |
Military Personnel
n=7 Participants
Military personnel with a history of head trauma and cognitive or mood symptoms.
|
Players
n=15 Participants
Retired football players with a history of head trauma and cognitive or mood symptoms.
|
Total
n=22 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45 years
n=99 Participants
|
54 years
n=107 Participants
|
49 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
14 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: BaselineThe 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).
Outcome measures
| Measure |
Military Personnel
n=7 Participants
Military personnel with a history of head trauma and cognitive or mood symptoms.
|
Players
n=15 Participants
Retired football players with a history of head trauma and cognitive or mood symptoms.
|
|---|---|---|
|
Distribution Volume Ratio (DVR)
Amygdala
|
1.30 Distribution Volume Ratio (DVR)
Standard Deviation 0.09
|
1.39 Distribution Volume Ratio (DVR)
Standard Deviation .10
|
|
Distribution Volume Ratio (DVR)
Midbrain
|
1.26 Distribution Volume Ratio (DVR)
Standard Deviation 0.14
|
1.34 Distribution Volume Ratio (DVR)
Standard Deviation 0.07
|
|
Distribution Volume Ratio (DVR)
Hypothalamus
|
1.32 Distribution Volume Ratio (DVR)
Standard Deviation .13
|
1.42 Distribution Volume Ratio (DVR)
Standard Deviation .08
|
|
Distribution Volume Ratio (DVR)
Thalamus
|
1.37 Distribution Volume Ratio (DVR)
Standard Deviation .14
|
1.51 Distribution Volume Ratio (DVR)
Standard Deviation .10
|
|
Distribution Volume Ratio (DVR)
Pons
|
1.27 Distribution Volume Ratio (DVR)
Standard Deviation .14
|
1.31 Distribution Volume Ratio (DVR)
Standard Deviation .07
|
|
Distribution Volume Ratio (DVR)
Striatum (caudate nucleus and putamen)
|
1.33 Distribution Volume Ratio (DVR)
Standard Deviation .10
|
1.53 Distribution Volume Ratio (DVR)
Standard Deviation .10
|
Adverse Events
Military Personnel
Players
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Gary Small
UCLA Semel Institute for Neuroscience and Human Behavior
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place