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Trial record 5 of 157 for:    (Dementia pugilistica OR chronic traumatic encephalopathy) AND Injuries

Tau Imaging of Chronic Traumatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT02191267
Recruitment Status : Completed
First Posted : July 16, 2014
Results First Posted : May 17, 2018
Last Update Posted : May 17, 2018
Sponsor:
Collaborators:
U.S. Army Medical Research and Development Command
Boston University
Information provided by (Responsible Party):
Martha E Shenton, Brigham and Women's Hospital

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Chronic Traumatic Encephalopathy
Interventions Radiation: [F18]-T807
Radiation: [F18]-Florbetapir
Device: MRI/MRS
Genetic: Genetic Analysis for Genetic Risk Score for Tau.
Enrollment 30
Recruitment Details 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.
Pre-assignment Details 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.
Arm/Group Title Presumed CTE Group Control Group AD Dementia Group
Hide Arm/Group Description

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.

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.

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.

Period Title: Overall Study
Started 20 6 4
Completed 19 6 4
Not Completed 1 0 0
Reason Not Completed
Withdrawal by Subject             1             0             0
Arm/Group Title Presumed CTE Group Control Group AD Dementia Group Total
Hide Arm/Group Description

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.

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.

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 of all reporting groups
Overall Number of Baseline Participants 19 6 4 29
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 6 participants 4 participants 29 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
 100.0%
6
 100.0%
4
 100.0%
29
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 6 participants 4 participants 29 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
19
 100.0%
6
 100.0%
4
 100.0%
29
 100.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 19 participants 6 participants 4 participants 29 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
6
  31.6%
1
  16.7%
0
   0.0%
7
  24.1%
White
13
  68.4%
5
  83.3%
4
 100.0%
22
  75.9%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 19 participants 6 participants 4 participants 29 participants
19 6 4 29
1.Primary Outcome
Title Tau Protein Uptake..
Hide Description 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.
Time Frame Day 1 - of 2 day study.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Presumed CTE Group Control Group AD Dementia Group
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 19 6 4
Mean (Standard Deviation)
Unit of Measure: SUVr
1.1871  (0.0762) 1.1652  (0.0670) 1.5910  (0.3807)
2.Secondary Outcome
Title Beta-Amyloid (Aβ) Protein Uptake.
Hide Description 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.
Time Frame Day 2 - of 2 day study.
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Presumed CTE Group Control Group AD Dementia Group
Hide Arm/Group Description:

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.

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.

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 Number of Participants Analyzed 19 6 4
Mean (Standard Deviation)
Unit of Measure: SUVr
Posterior Cingulate 1.346  (0.215) 1.290  (0.068) 1.760  (0.352)
Superior Parietal 1.225  (0.180) 1.118  (0.073) 1.708  (1.708)
Lateral Frontal 1.196  (0.178) 1.145  (0.085) 1.728  (0.291)
Medial Frontal 1.253  (0.190) 1.182  (0.083) 1.847  (0.261)
Lateral Temporal 1.178  (0.164) 1.113  (0.083) 1.766  (0.345)
Occipital 1.288  (0.191) 1.157  (0.039) 1.540  (1.540)
Time Frame Through study completion, Subjects were assessed for adverse effects immediately following each scan (On Day 1 and Day 2) and again by telephone 72 hours following study participation. Thus, assessment for adverse events were made over over a 5-day period which included Days 1 and 2 of the study visit and a follow-up telephone assessment on Day 5.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Presumed CTE Group Control Group AD Dementia Group
Hide Arm/Group Description

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.

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.

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.

All-Cause Mortality
Presumed CTE Group Control Group AD Dementia Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/6 (0.00%)   0/4 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Presumed CTE Group Control Group AD Dementia Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/6 (0.00%)   0/4 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Presumed CTE Group Control Group AD Dementia Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/19 (0.00%)   0/6 (0.00%)   0/4 (0.00%) 
Exploratory aims including potential MRI and MRS biomarkers and genetic analysis for genetic risk score for Tau will also be analyzed but are not primary or secondary outcome measures.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Martha Shenton
Organization: Brigham and Women's Hospital
Phone: 617-699-6152
EMail: shenton@bwh.harvard.edu
Layout table for additonal information
Responsible Party: Martha E Shenton, Brigham and Women's Hospital
ClinicalTrials.gov Identifier: NCT02191267     History of Changes
Other Study ID Numbers: 2014P000035
First Submitted: July 15, 2014
First Posted: July 16, 2014
Results First Submitted: March 15, 2018
Results First Posted: May 17, 2018
Last Update Posted: May 17, 2018