Trial Outcomes & Findings for 18F-AV-1451 and Florbetapir F 18 PET (Positron Emission Tomography) Imaging in Subjects at Risk for Chronic Traumatic Encephalopathy (NCT NCT02079766)
NCT ID: NCT02079766
Last Updated: 2020-09-07
Results Overview
Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
41 participants
Primary outcome timeframe
Baseline scan
Results posted on
2020-09-07
Participant Flow
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")
Participant milestones
| Measure |
High Risk of CTE
Subjects at high risk of developing CTE (chronic traumatic encephalopathy) - former National Football League players
|
Controls
Former non-contact athletes
|
|---|---|---|
|
Overall Study
STARTED
|
30
|
11
|
|
Overall Study
COMPLETED
|
28
|
11
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
High Risk of CTE
Subjects at high risk of developing CTE (chronic traumatic encephalopathy) - former National Football League players
|
Controls
Former non-contact athletes
|
|---|---|---|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
Baseline Characteristics
Only included subjects for which a florbetapir PET scan was available
Baseline characteristics by cohort
| Measure |
High Risk of CTE
n=29 Participants
Subjects at high risk of developing CTE (former National Football League players)
|
Controls
n=11 Participants
Former non-contact athletes
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.5 years
STANDARD_DEVIATION 8.27 • n=29 Participants
|
57.4 years
STANDARD_DEVIATION 6.25 • n=11 Participants
|
58.2 years
STANDARD_DEVIATION 7.71 • n=40 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=29 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
29 Participants
n=29 Participants
|
11 Participants
n=11 Participants
|
40 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=29 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=29 Participants
|
11 Participants
n=11 Participants
|
40 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=29 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=29 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=29 Participants
|
0 Participants
n=11 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
14 Participants
n=29 Participants
|
1 Participants
n=11 Participants
|
15 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=29 Participants
|
10 Participants
n=11 Participants
|
24 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=29 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=29 Participants
|
0 Participants
n=11 Participants
|
0 Participants
n=40 Participants
|
|
Region of Enrollment
United States
|
29 participants
n=29 Participants
|
11 participants
n=11 Participants
|
40 participants
n=40 Participants
|
|
MMSE
|
27.2 units on a scale
STANDARD_DEVIATION 1.64 • n=29 Participants
|
28.6 units on a scale
STANDARD_DEVIATION 0.92 • n=11 Participants
|
27.6 units on a scale
STANDARD_DEVIATION 1.60 • n=40 Participants
|
|
Amyloid status
Amyloid positive
|
3 Participants
n=28 Participants • Only included subjects for which a florbetapir PET scan was available
|
0 Participants
n=11 Participants • Only included subjects for which a florbetapir PET scan was available
|
3 Participants
n=39 Participants • Only included subjects for which a florbetapir PET scan was available
|
|
Amyloid status
Amyloid Negative
|
25 Participants
n=28 Participants • Only included subjects for which a florbetapir PET scan was available
|
11 Participants
n=11 Participants • Only included subjects for which a florbetapir PET scan was available
|
36 Participants
n=39 Participants • Only included subjects for which a florbetapir PET scan was available
|
PRIMARY outcome
Timeframe: Baseline scanPopulation: All subjects who received a flortaucipir scan
Flortaucipir uptake was rated visually by sponsor expert reader as 'No Uptake', 'Mild Uptake', 'Moderate Uptake', or 'Intense Uptake'.
Outcome measures
| Measure |
High Risk of CTE
n=28 Participants
Subjects at high risk of developing CTE (former National Football League players)
|
Controls
n=11 Participants
Former non-contact athletes
|
|---|---|---|
|
Flortaucipir Visual Read as CTE Biomarker
No Uptake
|
23 Participants
|
11 Participants
|
|
Flortaucipir Visual Read as CTE Biomarker
Mild Uptake
|
5 Participants
|
0 Participants
|
|
Flortaucipir Visual Read as CTE Biomarker
Moderate Uptake
|
0 Participants
|
0 Participants
|
|
Flortaucipir Visual Read as CTE Biomarker
Intense Uptake
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baseline scanPopulation: Only subjects at high risk for CTE were included in this analysis
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.
Outcome measures
| Measure |
High Risk of CTE
n=28 Participants
Subjects at high risk of developing CTE (former National Football League players)
|
Controls
Former non-contact athletes
|
|---|---|---|
|
Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)
No Uptake
|
27.348 score on a scale
Interval 26.625 to 28.071
|
—
|
|
Relationship Between Clinical Presentation and Tau Deposition (Subjects at High Risk of CTE Only)
Mild Uptake
|
26.800 score on a scale
Interval 25.249 to 28.351
|
—
|
Adverse Events
High Risk of CTE
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Controls
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
High Risk of CTE
n=29 participants at risk
Subjects at high risk of developing CTE (former National Football League players)
|
Controls
n=11 participants at risk
Former non-contact athletes
|
|---|---|---|
|
Nervous system disorders
headache
|
13.8%
4/29 • Number of events 4 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
18.2%
2/11 • Number of events 2 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
|
Gastrointestinal disorders
nausea
|
6.9%
2/29 • Number of events 2 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
0.00%
0/11 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
|
Gastrointestinal disorders
oral pain
|
6.9%
2/29 • Number of events 2 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
0.00%
0/11 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
|
Musculoskeletal and connective tissue disorders
muscle spasms
|
0.00%
0/29 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
18.2%
2/11 • Number of events 2 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
|
Nervous system disorders
dizziness
|
0.00%
0/29 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
9.1%
1/11 • Number of events 1 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
|
Gastrointestinal disorders
diarrhoea
|
3.4%
1/29 • Number of events 1 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
0.00%
0/11 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal discomfort
|
3.4%
1/29 • Number of events 1 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
0.00%
0/11 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
|
General disorders
fatigue
|
3.4%
1/29 • Number of events 1 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
0.00%
0/11 • End of study for AE reporting was 48 hours after the last study drug administration.
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
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60