Trial Outcomes & Findings for Tau Imaging of Chronic Traumatic Encephalopathy (NCT NCT02191267)
NCT ID: NCT02191267
Last Updated: 2018-05-17
Results Overview
Whole brain mean (and standard deviation) cortical value derived from standardized uptake value ratio (SUVr). Each \[F18\]-T807 tau scan consisted of a 60-minute dynamic acquisition after bolus intravenous injection of 10 mCi of \[18F\]-T807, followed by a second 20-minute dynamic imaging (list mode) acquisition from 80-100 minutes. SUVr images were constructed from the sum of the 80-100 minute frames resulting in late SUVr distribution maps.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
30 participants
Primary outcome timeframe
Day 1 - of 2 day study.
Results posted on
2018-05-17
Participant Flow
24 subjects at presumed risk for Chronic Traumatic Encephalopathy (CTE), 6 healthy control subjects without a history of repetitive brain trauma, and 4 Alzheimer's Disease (AD) subjects were recruited from the Boston University Center for the study of Chronic Traumatic Encephalopathy.
Subjects were pre-assigned according to previously assigned study diagnostic status based on prior participation in studies at the Boston Center for the study of Chronic Traumatic Encephalopathy.
Participant milestones
| Measure |
Presumed CTE Group
Interventions administered to the Presumed CTE Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
Control Group
Interventions administered to the Control Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
AD Dementia Group
Interventions administered to the AD Dementia Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
|---|---|---|---|
|
Overall Study
STARTED
|
20
|
6
|
4
|
|
Overall Study
COMPLETED
|
19
|
6
|
4
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
Presumed CTE Group
Interventions administered to the Presumed CTE Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
Control Group
Interventions administered to the Control Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
AD Dementia Group
Interventions administered to the AD Dementia Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
Baseline Characteristics
Tau Imaging of Chronic Traumatic Encephalopathy
Baseline characteristics by cohort
| Measure |
Presumed CTE Group
n=19 Participants
Interventions administered to the Presumed CTE Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
Control Group
n=6 Participants
Interventions administered to the Control Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
AD Dementia Group
n=4 Participants
Interventions administered to the AD Dementia Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
Total
n=29 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
19 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
6 participants
n=7 Participants
|
4 participants
n=5 Participants
|
29 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 1 - of 2 day study.Whole brain mean (and standard deviation) cortical value derived from standardized uptake value ratio (SUVr). Each \[F18\]-T807 tau scan consisted of a 60-minute dynamic acquisition after bolus intravenous injection of 10 mCi of \[18F\]-T807, followed by a second 20-minute dynamic imaging (list mode) acquisition from 80-100 minutes. SUVr images were constructed from the sum of the 80-100 minute frames resulting in late SUVr distribution maps.
Outcome measures
| Measure |
Presumed CTE Group
n=19 Participants
Interventions administered to the Presumed CTE Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
Control Group
n=6 Participants
Interventions administered to the Control Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
AD Dementia Group
n=4 Participants
Interventions administered to the AD Dementia Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
|---|---|---|---|
|
Tau Protein Uptake..
|
1.1871 SUVr
Standard Deviation 0.0762
|
1.1652 SUVr
Standard Deviation 0.0670
|
1.5910 SUVr
Standard Deviation 0.3807
|
SECONDARY outcome
Timeframe: Day 2 - of 2 day study.Mean and standard deviation for standardized uptake value ratios (SUVr) for posterior cingulate, superior parietal, lateral frontal, medial frontal, lateral temporal, and occipital brain regions. Each \[F18\]-Florbetapir (Beta-Amyloid) scan consisted of a 70-minute dynamic acquisition after bolus intravenous injection of 10 mCi of \[18F\]-Florbetapir. SUVr images were constructed from the sum of the 50-70 minute frames resulting in late SUVr distribution maps.
Outcome measures
| Measure |
Presumed CTE Group
n=19 Participants
Interventions administered to the Presumed CTE Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
Control Group
n=6 Participants
Interventions administered to the Control Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
AD Dementia Group
n=4 Participants
Interventions administered to the AD Dementia Group include: \[F-18\]-T807 PET Scan and \[F18\]-Florbetapir PET Scan.
\[F18\]-T807: \[F18\]-T807 PET Scan to measure tau deposition in the brain.
\[F18\]-Florbetapir: \[F18\]-Florbetapir PET scan to measure Beta-amyloid deposition in the brain.
|
|---|---|---|---|
|
Beta-Amyloid (Aβ) Protein Uptake.
Posterior Cingulate
|
1.346 SUVr
Standard Deviation 0.215
|
1.290 SUVr
Standard Deviation 0.068
|
1.760 SUVr
Standard Deviation 0.352
|
|
Beta-Amyloid (Aβ) Protein Uptake.
Superior Parietal
|
1.225 SUVr
Standard Deviation 0.180
|
1.118 SUVr
Standard Deviation 0.073
|
1.708 SUVr
Standard Deviation 1.708
|
|
Beta-Amyloid (Aβ) Protein Uptake.
Lateral Frontal
|
1.196 SUVr
Standard Deviation 0.178
|
1.145 SUVr
Standard Deviation 0.085
|
1.728 SUVr
Standard Deviation 0.291
|
|
Beta-Amyloid (Aβ) Protein Uptake.
Medial Frontal
|
1.253 SUVr
Standard Deviation 0.190
|
1.182 SUVr
Standard Deviation 0.083
|
1.847 SUVr
Standard Deviation 0.261
|
|
Beta-Amyloid (Aβ) Protein Uptake.
Lateral Temporal
|
1.178 SUVr
Standard Deviation 0.164
|
1.113 SUVr
Standard Deviation 0.083
|
1.766 SUVr
Standard Deviation 0.345
|
|
Beta-Amyloid (Aβ) Protein Uptake.
Occipital
|
1.288 SUVr
Standard Deviation 0.191
|
1.157 SUVr
Standard Deviation 0.039
|
1.540 SUVr
Standard Deviation 1.540
|
Adverse Events
Presumed CTE Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
AD Dementia Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place