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18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy

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ClinicalTrials.gov Identifier: NCT02079766
Recruitment Status : Completed
First Posted : March 6, 2014
Results First Posted : September 7, 2020
Last Update Posted : September 7, 2020
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Chronic Traumatic Encephalopathy
Interventions Drug: florbetapir F 18
Drug: Flortaucipir F18
Enrollment 41
Recruitment Details Subjects were recruited between June 2014 and October 2015 from the DETECT study (National Institutes of Health grant R01NS078337) and the Arizona Alzheimer's Consortium ("Long-Term Consequences of Repetitive Brain Injury in Athletes: A Longitudinal Study with Eventual Brain Donation")
Pre-assignment Details  
Arm/Group Title High Risk of CTE Controls
Hide Arm/Group Description Subjects at high risk of developing CTE (chronic traumatic encephalopathy) - former National Football League players Former non-contact athletes
Period Title: Overall Study
Started 30 11
Completed 28 11
Not Completed 2 0
Reason Not Completed
Physician Decision             1             0
Withdrawal by Subject             1             0
Arm/Group Title High Risk of CTE Controls Total
Hide Arm/Group Description Subjects at high risk of developing CTE (former National Football League players) Former non-contact athletes Total of all reporting groups
Overall Number of Baseline Participants 29 11 40
Hide Baseline Analysis Population Description
Includes all subjects who received at least one dose of florbetapir or flortaucipir
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 29 participants 11 participants 40 participants
58.5  (8.27) 57.4  (6.25) 58.2  (7.71)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 11 participants 40 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
29
 100.0%
11
 100.0%
40
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 11 participants 40 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
29
 100.0%
11
 100.0%
40
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 29 participants 11 participants 40 participants
American Indian or Alaska Native
0
   0.0%
0
   0.0%
0
   0.0%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
1
   3.4%
0
   0.0%
1
   2.5%
Black or African American
14
  48.3%
1
   9.1%
15
  37.5%
White
14
  48.3%
10
  90.9%
24
  60.0%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 29 participants 11 participants 40 participants
29 11 40
MMSE   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 29 participants 11 participants 40 participants
27.2  (1.64) 28.6  (0.92) 27.6  (1.60)
[1]
Measure Description: Mini-mental status exam is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment.
Amyloid status   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 28 participants 11 participants 39 participants
Amyloid positive
3
  10.7%
0
   0.0%
3
   7.7%
Amyloid Negative
25
  89.3%
11
 100.0%
36
  92.3%
[1]
Measure Description: Measured by flortaucipir PET scan visual read augmented with quantitative information
[2]
Measure Analysis Population Description: Only included subjects for which a florbetapir PET scan was available
1.Primary Outcome
Title Flortaucipir Visual Read as CTE Biomarker
Hide Description Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'.
Time Frame Baseline scan
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who received a flortaucipir scan
Arm/Group Title High Risk of CTE Controls
Hide Arm/Group Description:
Subjects at high risk of developing CTE (former National Football League players)
Former non-contact athletes
Overall Number of Participants Analyzed 28 11
Measure Type: Count of Participants
Unit of Measure: Participants
No Uptake
23
  82.1%
11
 100.0%
Mild Uptake
5
  17.9%
0
   0.0%
Moderate Uptake
0
   0.0%
0
   0.0%
Intense Uptake
0
   0.0%
0
   0.0%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Risk of CTE, Controls
Comments Evaluated the association between the overall brain uptake and the study group
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2959
Comments No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.
Method Fisher Exact
Comments [Not Specified]
2.Primary Outcome
Title Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)
Hide Description The relationship between flortaucipir uptake and clinical presentation, as measured by the Mini-Mental State Examination (MMSE). Mini-mental status exam is a 30-point questionnaire that is used to measure cognitive impairment. Scores range from 0 to 30 with lower scores representing greater levels of cognitive impairment. Specified in statistical analysis plan to only be conducted in High Risk of CTE group.
Time Frame baseline scan
Hide Outcome Measure Data
Hide Analysis Population Description
Only subjects at high risk for CTE were included in this analysis
Arm/Group Title High Risk of CTE
Hide Arm/Group Description:
Subjects at high risk of developing CTE (former National Football League players)
Overall Number of Participants Analyzed 28
Least Squares Mean (95% Confidence Interval)
Unit of Measure: score on a scale
No Uptake Number Analyzed 23 participants
27.348
(26.625 to 28.071)
Mild Uptake Number Analyzed 5 participants
26.800
(25.249 to 28.351)
Moderate Uptake Number Analyzed 0 participants
Intense Uptake Number Analyzed 0 participants
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection High Risk of CTE
Comments Measured differences in clinical presentation using MMSE between subjects with no visual flortaucipir uptake, and those with mild uptake.
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.5163
Comments No adjustments for multiple comparisons or multiplicity were made for this study. No a priori threshold for significance was chosen.
Method ANOVA
Comments MMSE score as the response variable and flortaucipir uptake score (4 levels) as the fixed effect
Time Frame End of study for AE reporting was 48 hours after the last study drug administration.
Adverse Event Reporting Description Adverse events (AEs) were collected at scan visits, regardless of attribution to study drug. AEs occurring after study drug administration, but outside that window were not recorded, unless considered attributable to either drug. Includes all subjects who received at least one dose of florbetapir or flortaucipir
 
Arm/Group Title High Risk of CTE Controls
Hide Arm/Group Description Subjects at high risk of developing CTE (former National Football League players) Former non-contact athletes
All-Cause Mortality
High Risk of CTE Controls
Affected / at Risk (%) Affected / at Risk (%)
Total   0/29 (0.00%)      0/11 (0.00%)    
Hide Serious Adverse Events
High Risk of CTE Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/29 (0.00%)      0/11 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
High Risk of CTE Controls
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   11/29 (37.93%)      5/11 (45.45%)    
Gastrointestinal disorders     
nausea  1  2/29 (6.90%)  2 0/11 (0.00%)  0
oral pain  1  2/29 (6.90%)  2 0/11 (0.00%)  0
diarrhoea  1  1/29 (3.45%)  1 0/11 (0.00%)  0
General disorders     
fatigue  1  1/29 (3.45%)  1 0/11 (0.00%)  0
Musculoskeletal and connective tissue disorders     
muscle spasms  1  0/29 (0.00%)  0 2/11 (18.18%)  2
musculoskeletal discomfort  1  1/29 (3.45%)  1 0/11 (0.00%)  0
Nervous system disorders     
headache  1  4/29 (13.79%)  4 2/11 (18.18%)  2
dizziness  1  0/29 (0.00%)  0 1/11 (9.09%)  1
1
Term from vocabulary, MedDRA 17.1
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS 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: Medical Director
Organization: Avid Radiopharmaceuticals, Inc.
Phone: 215-298-0700
EMail: clinicaloperations@avidrp.com
Layout table for additonal information
Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT02079766    
Other Study ID Numbers: 18F-AV-1451-A07
First Submitted: March 4, 2014
First Posted: March 6, 2014
Results First Submitted: June 27, 2020
Results First Posted: September 7, 2020
Last Update Posted: September 7, 2020