Trial Outcomes & Findings for 18F-AV-1451 High Resolution Autopsy Study (NCT NCT02350634)
NCT ID: NCT02350634
Last Updated: 2025-06-10
Results Overview
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation.
COMPLETED
PHASE1
3 participants
autopsy within 6 months of scan
2025-06-10
Participant Flow
Enrollment was opened in June 2015 and closed in May 2018. First patient enrolled in November 2016 and last enrolled patient completed the study procedures in June 2017. Study enrolled end-of-life subjects (life expectancy less than 6 months) at medical centers in the US who consented to a flortaucipir PET scan and to brain donation at autopsy.
To be considered eligible for the primary analysis, death had to occur within 6 months of flortaucipir scan and valid autopsy was required.
Participant milestones
| Measure |
All Enrolled Cohort
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq (10 mCi) of flortaucipir.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
2
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
All Enrolled Cohort
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects will receive a single IV bolus injection of 370 MBq (10 mCi) of flortaucipir.
|
|---|---|
|
Overall Study
subject survived greater than 6 months following dosing
|
1
|
Baseline Characteristics
n=2 for cognitively impaired subjects. Cognitively normal subject mental status was not measured.
Baseline characteristics by cohort
| Measure |
All Enrolled Cohort
n=3 Participants
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq (10 mCi) of flortaucipir.
|
|---|---|
|
Age, Continuous
|
76.00 years
STANDARD_DEVIATION 11.533 • n=3 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=3 Participants
|
|
Mini Mental Status Exam (MMSE) Score
|
14.50 units on a scale
STANDARD_DEVIATION 20.5061 • n=2 Participants • n=2 for cognitively impaired subjects. Cognitively normal subject mental status was not measured.
|
|
Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) Score
|
4.75 units on a scale
STANDARD_DEVIATION 0.4330 • n=3 Participants
|
PRIMARY outcome
Timeframe: autopsy within 6 months of scanPopulation: One subject did not come to autopsy within 6 months of the flortaucipir scan.
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of whole cortical global quantitation of the PET scan from 82 FreeSurfer-defined regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range 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=2 Participants
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir and came to autopsy within 6 months of flortaucipir scan.
|
|---|---|
|
Relationship of Flortaucipir Scan and Pathology - Whole Cortical Composite Region
|
0.429 Correlation coefficient
|
PRIMARY outcome
Timeframe: autopsy within 6 months of scanPopulation: One subject did not come to autopsy within 6 months of the flortaucipir scan.
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of frontal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range 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=2 Participants
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir and came to autopsy within 6 months of flortaucipir scan.
|
|---|---|
|
Relationship of Flortaucipir Scan and Pathology - Frontal Composite Region
|
0.681 Correlation coefficient
|
PRIMARY outcome
Timeframe: autopsy within 6 months of scanPopulation: One subject did not come to autopsy within 6 months of the flortaucipir scan.
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of parietal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range 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=2 Participants
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir and came to autopsy within 6 months of flortaucipir scan.
|
|---|---|
|
Relationship of Flortaucipir Scan and Pathology - Parietal Composite Region
|
0.644 Correlation coefficient
|
PRIMARY outcome
Timeframe: autopsy within 6 months of scanPopulation: One subject did not come to autopsy within 6 months of the flortaucipir scan.
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of cingulate composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range 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=2 Participants
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir and came to autopsy within 6 months of flortaucipir scan.
|
|---|---|
|
Relationship of Flortaucipir Scan and Pathology - Cingulate Composite Region
|
0.437 Correlation coefficient
|
PRIMARY outcome
Timeframe: autopsy within 6 months of scanPopulation: One subject did not come to autopsy within 6 months of the flortaucipir scan.
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of temporal composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range 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=2 Participants
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir and came to autopsy within 6 months of flortaucipir scan.
|
|---|---|
|
Relationship of Flortaucipir Scan and Pathology - Temporal Composite Region
|
0.324 Correlation coefficient
|
PRIMARY outcome
Timeframe: autopsy within 6 months of scanPopulation: One subject did not come to autopsy within 6 months of the flortaucipir scan.
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of occipital composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range 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=2 Participants
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir and came to autopsy within 6 months of flortaucipir scan.
|
|---|---|
|
Relationship of Flortaucipir Scan and Pathology - Occipital Composite Region
|
0.564 Correlation coefficient
|
PRIMARY outcome
Timeframe: autopsy within 6 months of scanPopulation: One subject did not come to autopsy within 6 months of the flortaucipir scan.
Correlation between flortaucipir standard uptake value ratio (SUVr) and neuropathology at autopsy. SUVr measurements for the analysis consisted of limbic composite region quantitation of the PET scan regions of interest (ROIs). Values were normalized to the brainstem to obtain the SUVr. Neuropathology was measured by immunohistology using AT8 antibody. Spearman correlation coefficient was calculated. Spearman correlation coefficients range 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=2 Participants
End-of-life subjects (life expectancy \< 6 months) consenting to brain donation at autopsy. Subjects received a single IV bolus injection of 370 MBq(10 mCi) of flortaucipir and came to autopsy within 6 months of flortaucipir scan.
|
|---|---|
|
Relationship of Flortaucipir Scan and Pathology - Limbic Composite Region
|
-0.189 Correlation coefficient
|
Adverse Events
Safety Analysis Cohort
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place