Trial Outcomes & Findings for Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain (NCT NCT00857415)
NCT ID: NCT00857415
Last Updated: 2012-05-22
Results Overview
Spearman's rank order correlation of the median semi-quantitative visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
COMPLETED
PHASE3
226 participants
at autopsy up to 12 months post-scan
2012-05-22
Participant Flow
Participant milestones
| Measure |
Autopsy Cohort
End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
Specificity Cohort
Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
|---|---|---|
|
Overall Study
STARTED
|
152
|
74
|
|
Overall Study
Deceased Within One Year of AV-45 Scan
|
37
|
0
|
|
Overall Study
COMPLETED
|
35
|
74
|
|
Overall Study
NOT COMPLETED
|
117
|
0
|
Reasons for withdrawal
| Measure |
Autopsy Cohort
End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
Specificity Cohort
Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
|---|---|---|
|
Overall Study
Image acquisition failure
|
2
|
0
|
|
Overall Study
Invalid image or not imaged
|
3
|
0
|
|
Overall Study
Subject still living at end of study
|
110
|
0
|
|
Overall Study
Deceased with no autopsy
|
2
|
0
|
Baseline Characteristics
Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain
Baseline characteristics by cohort
| Measure |
Autopsy Cohort
n=152 Participants
End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
Specificity Cohort
n=74 Participants
Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
Total
n=226 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
78.1 years
STANDARD_DEVIATION 13.35 • n=99 Participants
|
26.6 years
STANDARD_DEVIATION 6.50 • n=107 Participants
|
61.3 years
STANDARD_DEVIATION 26.84 • n=206 Participants
|
|
Sex: Female, Male
Female
|
81 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
107 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
71 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
119 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
152 participants
n=99 Participants
|
74 participants
n=107 Participants
|
226 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: at autopsy up to 12 months post-scanPopulation: All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners
Spearman's rank order correlation of the median semi-quantitative visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Outcome measures
| Measure |
Autopsy Cohort
n=29 Participants
End-of-life subjects consenting to brain donation at autopsy
|
|---|---|
|
Correlation of Florbetapir-PET Image and Amyloid Plaque Density
|
0.78 Correlation coefficient
Interval 0.58 to 0.89
|
PRIMARY outcome
Timeframe: 50-60 min after injectionPopulation: Per protocol, 27 subjects who were genetic carriers for ApoE e4 or whose genetic status was unknown were excluded from the analysis
Specificity of florbetapir-PET scan in younger healthy controls presumed to be negative for amyloid. Specificity results are reported as the number of subjects who had a negative scan based on majority of 3 blinded readers.
Outcome measures
| Measure |
Autopsy Cohort
n=47 Participants
End-of-life subjects consenting to brain donation at autopsy
|
|---|---|
|
Specificity Analysis
Positive for amyloid
|
0 participants
Interval 91.0 to 100.0
|
|
Specificity Analysis
Negative for amyloid
|
47 participants
|
SECONDARY outcome
Timeframe: at autopsy up to 12 months post-scanPopulation: All subjects with a valid image who came to autopsy within 1 year of scan, minus 6 subjects who served as front-runners
Spearman's rank order correlation of median visual read of the florbetapir-PET image vs. amyloid plaque density assessed post-mortem by quantitative IHC of six individual brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
Outcome measures
| Measure |
Autopsy Cohort
n=29 Participants
End-of-life subjects consenting to brain donation at autopsy
|
|---|---|
|
Regional Correlation Analysis
Precuneus
|
0.75 Correlation coefficient
Interval 0.53 to 0.88
|
|
Regional Correlation Analysis
Parietal cortex
|
0.77 Correlation coefficient
Interval 0.56 to 0.88
|
|
Regional Correlation Analysis
Frontal cortex
|
0.69 Correlation coefficient
Interval 0.44 to 0.84
|
|
Regional Correlation Analysis
Temporal cortex
|
0.68 Correlation coefficient
Interval 0.42 to 0.84
|
|
Regional Correlation Analysis
Posterior cingulate
|
0.70 Correlation coefficient
Interval 0.44 to 0.85
|
|
Regional Correlation Analysis
Anterior cingulate
|
0.74 Correlation coefficient
Interval 0.51 to 0.87
|
Adverse Events
Autopsy Cohort
Specificity Cohort
Serious adverse events
| Measure |
Autopsy Cohort
n=152 participants at risk
End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
Specificity Cohort
n=74 participants at risk
Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.66%
1/152 • Number of events 152 • AEs were collected up to 48 hours after injection. SAEs were collected up to 30 days after injection.
|
0.00%
0/74 • AEs were collected up to 48 hours after injection. SAEs were collected up to 30 days after injection.
|
Other adverse events
| Measure |
Autopsy Cohort
n=152 participants at risk
End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
Specificity Cohort
n=74 participants at risk
Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
|
|---|---|---|
|
Nervous system disorders
Headache
|
2.0%
3/152 • Number of events 3 • AEs were collected up to 48 hours after injection. SAEs were collected up to 30 days after injection.
|
2.7%
2/74 • Number of events 2 • AEs were collected up to 48 hours after injection. SAEs were collected up to 30 days after injection.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60