Trial Outcomes & Findings for Tau Imaging in Professional Fighters (NCT NCT02278354)
NCT ID: NCT02278354
Last Updated: 2020-09-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
35 participants
Primary outcome timeframe
baseline scan
Results posted on
2020-09-10
Participant Flow
Enrollment occurred between Feb 2015 and Feb 2017
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.
Participant milestones
| Measure |
Active Professional Fighters
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
|
Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
23
|
|
Overall Study
Flortaucipir PET Scan
|
10
|
20
|
|
Overall Study
COMPLETED
|
8
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Active Professional Fighters
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
|
Retired Professional Fighters
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
<10 professional fights
|
2
|
0
|
Baseline Characteristics
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)
Baseline characteristics by cohort
| Measure |
Active Professional Fighters
n=10 Participants
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
|
Retired Professional Fighters
n=20 Participants
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.7 years
STANDARD_DEVIATION 4.27 • n=10 Participants
|
47.6 years
STANDARD_DEVIATION 10.21 • n=20 Participants
|
42.3 years
STANDARD_DEVIATION 11.49 • n=30 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=10 Participants
|
20 Participants
n=20 Participants
|
30 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=10 Participants
|
9 Participants
n=20 Participants
|
10 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
9 Participants
n=10 Participants
|
11 Participants
n=20 Participants
|
20 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
5 Participants
n=10 Participants
|
7 Participants
n=20 Participants
|
12 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
White
|
3 Participants
n=10 Participants
|
13 Participants
n=20 Participants
|
16 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=30 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=10 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=30 Participants
|
|
Region of Enrollment
United States
|
10 participants
n=10 Participants
|
20 participants
n=20 Participants
|
30 participants
n=30 Participants
|
|
Amyloid status
Amyloid negative
|
1 Participants
n=1 Participants • 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)
|
14 Participants
n=14 Participants • 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)
|
15 Participants
n=15 Participants • 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)
|
|
Amyloid status
Amyloid positive
|
0 Participants
n=1 Participants • 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)
|
0 Participants
n=14 Participants • 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)
|
0 Participants
n=15 Participants • 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)
|
PRIMARY outcome
Timeframe: baseline scanPopulation: Cognitively impaired fighters either had subjective cognitive complaints or objective decline or impairment as determined by the investigator.
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.
Outcome measures
| Measure |
Cognitively Impaired Fighters
n=18 Participants
Fighters (active and retired) with cognitive impairment at baseline
|
Cognitively Normal Fighters
n=12 Participants
Fighters (active and retired) without cognitive impairment at baseline
|
|---|---|---|
|
Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Weighted cortical average
|
1.0048 standardized uptake value ratio (SUVr)
Interval 0.977 to 1.0327
|
0.971 standardized uptake value ratio (SUVr)
Interval 0.9401 to 1.002
|
|
Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Frontal
|
0.9731 standardized uptake value ratio (SUVr)
Interval 0.9394 to 1.0068
|
0.9357 standardized uptake value ratio (SUVr)
Interval 0.8983 to 0.9732
|
|
Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Temporal
|
0.9867 standardized uptake value ratio (SUVr)
Interval 0.9425 to 1.0309
|
0.9305 standardized uptake value ratio (SUVr)
Interval 0.8812 to 0.9797
|
|
Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Parietal
|
0.9472 standardized uptake value ratio (SUVr)
Interval 0.9097 to 0.9847
|
0.9288 standardized uptake value ratio (SUVr)
Interval 0.8871 to 0.9705
|
|
Flortaucipir Imaging (Quantitative) Between Cognitive Groups
Occipital
|
0.9513 standardized uptake value ratio (SUVr)
Interval 0.912 to 0.9906
|
0.9247 standardized uptake value ratio (SUVr)
Interval 0.8809 to 0.9684
|
PRIMARY outcome
Timeframe: baseline scanStandard 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.
Outcome measures
| Measure |
Cognitively Impaired Fighters
n=10 Participants
Fighters (active and retired) with cognitive impairment at baseline
|
Cognitively Normal Fighters
n=20 Participants
Fighters (active and retired) without cognitive impairment at baseline
|
|---|---|---|
|
Flortaucipir Imaging (Quantitative) Between Fighter Groups
Weighted cortical average
|
0.9965 standardized uptake value ratio (SUVr)
Interval 0.963 to 1.0299
|
0.9794 standardized uptake value ratio (SUVr)
Interval 0.9546 to 1.0042
|
|
Flortaucipir Imaging (Quantitative) Between Fighter Groups
Frontal
|
0.9816 standardized uptake value ratio (SUVr)
Interval 0.9411 to 1.022
|
0.9273 standardized uptake value ratio (SUVr)
Interval 0.8973 to 0.9572
|
|
Flortaucipir Imaging (Quantitative) Between Fighter Groups
Temporal
|
0.9838 standardized uptake value ratio (SUVr)
Interval 0.9306 to 1.0369
|
0.9334 standardized uptake value ratio (SUVr)
Interval 0.894 to 0.9728
|
|
Flortaucipir Imaging (Quantitative) Between Fighter Groups
Parietal
|
0.9623 standardized uptake value ratio (SUVr)
Interval 0.9172 to 1.0073
|
0.9137 standardized uptake value ratio (SUVr)
Interval 0.8803 to 0.9471
|
|
Flortaucipir Imaging (Quantitative) Between Fighter Groups
Occipital
|
0.9632 standardized uptake value ratio (SUVr)
Interval 0.916 to 1.0105
|
0.9127 standardized uptake value ratio (SUVr)
Interval 0.8777 to 0.9478
|
PRIMARY outcome
Timeframe: baseline scanPopulation: Cognitively impaired fighters either had subjective cognitive complaints or objective decline or impairment as determined by the investigator.
Qualitative read results (no, mild, moderate, or intense uptake) compared between cognitively impaired (CI) and cognitively normal (CN) groups.
Outcome measures
| Measure |
Cognitively Impaired Fighters
n=18 Participants
Fighters (active and retired) with cognitive impairment at baseline
|
Cognitively Normal Fighters
n=12 Participants
Fighters (active and retired) without cognitive impairment at baseline
|
|---|---|---|
|
Flortaucipir Imaging (Qualitative) Between Cognitive Groups
Moderate Uptake
|
0 Participants
|
0 Participants
|
|
Flortaucipir Imaging (Qualitative) Between Cognitive Groups
No Uptake
|
16 Participants
|
12 Participants
|
|
Flortaucipir Imaging (Qualitative) Between Cognitive Groups
Mild Uptake
|
2 Participants
|
0 Participants
|
|
Flortaucipir Imaging (Qualitative) Between Cognitive Groups
Intense Uptake
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baseline scanQualitative read results (no, mild, moderate, or intense uptake) compared between active and retired fighter groups
Outcome measures
| Measure |
Cognitively Impaired Fighters
n=10 Participants
Fighters (active and retired) with cognitive impairment at baseline
|
Cognitively Normal Fighters
n=20 Participants
Fighters (active and retired) without cognitive impairment at baseline
|
|---|---|---|
|
Flortaucipir Imaging (Qualitative) Between Fighter Groups
No Uptake
|
10 Participants
|
18 Participants
|
|
Flortaucipir Imaging (Qualitative) Between Fighter Groups
Mild Uptake
|
0 Participants
|
2 Participants
|
|
Flortaucipir Imaging (Qualitative) Between Fighter Groups
Moderate Uptake
|
0 Participants
|
0 Participants
|
|
Flortaucipir Imaging (Qualitative) Between Fighter Groups
Intense Uptake
|
0 Participants
|
0 Participants
|
Adverse Events
Active Professional Fighters
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Retired Professional Fighters
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Active Professional Fighters
n=10 participants at risk
Active professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
|
Retired Professional Fighters
n=20 participants at risk
Retired professional fighters (with and without cognitive impairment) receiving a flortaucipir PET scan
|
|---|---|---|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/10 • End of study for AE reporting was 48 hours after the last study drug administration.
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.
|
5.0%
1/20 • Number of events 1 • End of study for AE reporting was 48 hours after the last study drug administration.
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.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
0.00%
0/10 • End of study for AE reporting was 48 hours after the last study drug administration.
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.
|
5.0%
1/20 • Number of events 1 • End of study for AE reporting was 48 hours after the last study drug administration.
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60