We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Tau Imaging in Professional Fighters

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278354
Recruitment Status : Completed
First Posted : October 30, 2014
Results First Posted : September 10, 2020
Last Update Posted : September 10, 2020
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition Alzheimer's Disease
Interventions Drug: Flortaucipir F18
Procedure: Brain PET scan
Enrollment 35
Recruitment Details Enrollment occurred between Feb 2015 and Feb 2017
Pre-assignment Details Five subjects enrolled in the study but did not receive a flortaucipir PET scan (2 active, 3 retired). Two additional subjects in the active fighters group did not have the minimum 10 fights required for inclusion into the study, and therefore were considered not to have completed the study. However, their PET scan results were analyzed.
Arm/Group Title Active Professional Fighters Retired Professional Fighters
Hide Arm/Group Description Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Period Title: Overall Study
Started 12 23
Flortaucipir PET Scan 10 20
Completed 8 20
Not Completed 4 3
Reason Not Completed
Lost to Follow-up             2             2
Withdrawal by Subject             0             1
<10 professional fights             2             0
Arm/Group Title Active Professional Fighters Retired Professional Fighters Total
Hide Arm/Group Description Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan Total of all reporting groups
Overall Number of Baseline Participants 10 20 30
Hide Baseline Analysis Population Description
Only includes subjects who received a flortaucipir PET scan in the study.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 10 participants 20 participants 30 participants
31.7  (4.27) 47.6  (10.21) 42.3  (11.49)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
Male
10
 100.0%
20
 100.0%
30
 100.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 participants
Hispanic or Latino
1
  10.0%
9
  45.0%
10
  33.3%
Not Hispanic or Latino
9
  90.0%
11
  55.0%
20
  66.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 10 participants 20 participants 30 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
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
5
  50.0%
7
  35.0%
12
  40.0%
White
3
  30.0%
13
  65.0%
16
  53.3%
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%
Other
2
  20.0%
0
   0.0%
2
   6.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 10 participants 20 participants 30 participants
10 20 30
Amyloid status   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants 14 participants 15 participants
Amyloid negative
1
 100.0%
14
 100.0%
15
 100.0%
Amyloid positive
0
   0.0%
0
   0.0%
0
   0.0%
[1]
Measure Description: Amyloid status determined by florbetapir PET scan
[2]
Measure Analysis Population Description: Per protocol, baseline amyloid status was only obtained for fighters > 50 years of age or with a clinical presentation that suggested a possible Alzheimer's disease diagnosis (n=15)
1.Primary Outcome
Title Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Hide Description Standard Uptake Value Ratio (SUVr) by subject enrollment group (cognitive impaired/normal) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Time Frame baseline scan
Hide Outcome Measure Data
Hide Analysis Population Description
Cognitively impaired fighters either had subjective cognitive complaints or objective decline or impairment as determined by the investigator.
Arm/Group Title Cognitively Impaired Fighters Cognitively Normal Fighters
Hide Arm/Group Description:
Fighters (active and retired) with cognitive impairment at baseline
Fighters (active and retired) without cognitive impairment at baseline
Overall Number of Participants Analyzed 18 12
Least Squares Mean (95% Confidence Interval)
Unit of Measure: standardized uptake value ratio (SUVr)
Weighted cortical average
1.0048
(0.977 to 1.0327)
0.971
(0.9401 to 1.002)
Frontal
0.9731
(0.9394 to 1.0068)
0.9357
(0.8983 to 0.9732)
Temporal
0.9867
(0.9425 to 1.0309)
0.9305
(0.8812 to 0.9797)
Parietal
0.9472
(0.9097 to 0.9847)
0.9288
(0.8871 to 0.9705)
Occipital
0.9513
(0.912 to 0.9906)
0.9247
(0.8809 to 0.9684)
2.Primary Outcome
Title Flortaucipir Imaging (Quantitative) Between Fighter Groups
Hide Description Standard Uptake Value Ratio (SUVr) by subject enrollment group (active fighter/retired fighter) across weighted cortical average, frontal, temporal, parietal, and occipital brain regions. For SUVr, a value of 1 or lower signifies no flortaucipir activity above background, values greater than 1 signify increasing flortaucipir activity in the brain.
Time Frame baseline scan
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Professional Fighters Retired Professional Fighters
Hide Arm/Group Description:
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Overall Number of Participants Analyzed 10 20
Least Squares Mean (95% Confidence Interval)
Unit of Measure: standardized uptake value ratio (SUVr)
Weighted cortical average
0.9965
(0.963 to 1.0299)
0.9794
(0.9546 to 1.0042)
Frontal
0.9816
(0.9411 to 1.022)
0.9273
(0.8973 to 0.9572)
Temporal
0.9838
(0.9306 to 1.0369)
0.9334
(0.894 to 0.9728)
Parietal
0.9623
(0.9172 to 1.0073)
0.9137
(0.8803 to 0.9471)
Occipital
0.9632
(0.916 to 1.0105)
0.9127
(0.8777 to 0.9478)
3.Primary Outcome
Title Flortaucipir Imaging (Qualitative) Between Cognitive Groups
Hide Description Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.
Time Frame baseline scan
Hide Outcome Measure Data
Hide Analysis Population Description
Cognitively impaired fighters either had subjective cognitive complaints or objective decline or impairment as determined by the investigator.
Arm/Group Title Cognitively Impaired Fighters Cognitively Normal Fighters
Hide Arm/Group Description:
Fighters (active and retired) with cognitive impairment at baseline
Fighters (active and retired) without cognitive impairment at baseline
Overall Number of Participants Analyzed 18 12
Measure Type: Count of Participants
Unit of Measure: Participants
No Uptake
16
  88.9%
12
 100.0%
Mild Uptake
2
  11.1%
0
   0.0%
Moderate Uptake
0
   0.0%
0
   0.0%
Intense Uptake
0
   0.0%
0
   0.0%
4.Primary Outcome
Title Flortaucipir Imaging (Qualitative) Between Fighter Groups
Hide Description Qualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups
Time Frame baseline scan
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Professional Fighters Retired Professional Fighters
Hide Arm/Group Description:
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
Overall Number of Participants Analyzed 10 20
Measure Type: Count of Participants
Unit of Measure: Participants
No Uptake
10
 100.0%
18
  90.0%
Mild Uptake
0
   0.0%
2
  10.0%
Moderate Uptake
0
   0.0%
0
   0.0%
Intense Uptake
0
   0.0%
0
   0.0%
Time Frame End of study for AE reporting was 48 hours after the last study drug administration.
Adverse Event Reporting Description Adverse Events were defined as occurring or worsening after injection of dose, within 48 hours post injection. AEs occurring after flortaucipir administration, but outside that window were not recorded in the database, unless considered attributable to flortaucipir injection.
 
Arm/Group Title Active Professional Fighters Retired Professional Fighters
Hide Arm/Group Description Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
All-Cause Mortality
Active Professional Fighters Retired Professional Fighters
Affected / at Risk (%) Affected / at Risk (%)
Total   0/10 (0.00%)      0/20 (0.00%)    
Hide Serious Adverse Events
Active Professional Fighters Retired Professional Fighters
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      0/20 (0.00%)    
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1.0%
Active Professional Fighters Retired Professional Fighters
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/10 (0.00%)      2/20 (10.00%)    
Gastrointestinal disorders     
diarrhoea  1  0/10 (0.00%)  0 1/20 (5.00%)  1
Respiratory, thoracic and mediastinal disorders     
epistaxis  1  0/10 (0.00%)  0 1/20 (5.00%)  1
1
Term from vocabulary, MedDRA (17.0)
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: NCT02278354    
Other Study ID Numbers: 18F-AV-1451-A11
First Submitted: October 28, 2014
First Posted: October 30, 2014
Results First Submitted: July 16, 2020
Results First Posted: September 10, 2020
Last Update Posted: September 10, 2020