A Phase 4 interventional study of Florbetapir (18F) in Alzheimer's Disease, sponsored by Avid Radiopharmaceuticals. Completed at 1 site in Netherlands. Per ClinicalTrials.gov, last updated 2015-07-09.
Sponsored by Avid Radiopharmaceuticals · Phase 4, Interventional, and Diagnostic
This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.
3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.
This study's enrollment of 96 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.
Browse Alzheimer Disease studies →Avid Radiopharmaceuticals is the lead sponsor of 54 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 10 (91%) have results posted.
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Exclusion Criteria:
Physician readers will interpret Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to Florbetapir(18F) as part of this study.
Drug: Florbetapir (18F)
No Florbetapir (18F) will be administered in this study.
Also known as: Florbetapir F 18, Amyvid, 18F-AV-45
Change in Reader Accuracy After Application of Quantitation Software
Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values \>0 indicate an improvement in scan interpretation accuracy and values \<0 indicate a decline in scan interpretation accuracy after application of quantitation software. NRI = \[P(up,event)-P(down,event)\]-\[P(up,nonevent)-P(down,nonevent)\] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative Only the 46 scans with autopsy from A16 are used for this outcome measure.
Time frame: Scan acquired 50-60 minutes post injection
Change in Scan Interpretation Reliability After Application of Quantitation Software
Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values \>0 indicate an improvement in scan interpretation accuracy and values \<0 indicate a decline in scan interpretation accuracy after application of quantitation software. NRI = \[P(up,event)-P(down,event)\]-\[P(up,nonevent)-P(down,nonevent)\] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative Only the 46 scans with autopsy from A16 are used for this outcome measure.
Time frame: Scan acquired 50-60 minutes post injection
| Milestone | Florbetapir PET Scans |
|---|---|
| Started | 96 |
| Completed | 96 |
| Not completed | 0 |
Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values \>0 indicate an improvement in scan interpretation accuracy and values \<0 indicate a decline in scan interpretation accuracy after application of quantitation software. NRI = \[P(up,event)-P(down,event)\]-\[P(up,nonevent)-P(down,nonevent)\] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative Only the 46 scans with autopsy from A16 are used for this outcome measure.
| Net Reclassification Index | Physician Readers |
|---|---|
| Change in Reader Accuracy After Application of Quantitation Software | 0.0746 |
Evaluate whether the use of quantitation software improves florbetapir (18F) scan interpretation by using the net reclassification index (NRI). The NRI is a prospective measure that quantifies the correctness of upward and downward reclassification or movement of predicted probabilities as a result of adding a new marker. NRI Values \>0 indicate an improvement in scan interpretation accuracy and values \<0 indicate a decline in scan interpretation accuracy after application of quantitation software. NRI = \[P(up,event)-P(down,event)\]-\[P(up,nonevent)-P(down,nonevent)\] Where P(up,event) = # events up/# events P(down,event) = # events down/# events P(up,nonevent) = # nonevents up/# nonevents P(down,nonevent) = # nonevents down/# nonevents and events: true positive case nonevents: true negative case up: scan change from negative to positive down: scan change from positive to negative Only the 46 scans with autopsy from A16 are used for this outcome measure.
| Fleiss Kappa | All Study Cases | Autopsy Cases | Non-autopsy Cases |
|---|---|---|---|
| Kappa VisQ | 0.73 (0.712 to 0.740) | 0.72 (0.703 to 0.743) | 0.73 (0.709 to 0.747) |
| Kappa Qualitative | 0.66 (0.647 to 0.675) | 0.66 (0.644 to 0.684) | 0.66 (0.638 to 0.676) |
| Change in Kappa | 0.06 (0.017 to 0.112) | 0.06 (-0.015 to 0.132) | 0.07 (0.008 to 0.133) |
Collected over No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A16, and A17).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Florbetapir PET Scans | — | — | — |
| Age, Continuous(years) | Florbetapir PET Scans |
|---|---|
| Mean | 76.9 ± 10.23 |
| Sex: Female, Male(Participants) | Florbetapir PET Scans |
|---|---|
| Female | 48 |
| Male | 48 |
| Ethnicity (NIH/OMB)(Participants) | Florbetapir PET Scans |
|---|---|
| Hispanic or Latino | 4 |
| Not Hispanic or Latino | 92 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(participants) | Florbetapir PET Scans |
|---|---|
| Asian | 1 |
| Black or African American | 5 |
| White | 89 |
| Other | 1 |
| Region of Enrollment(participants) | Florbetapir PET Scans |
|---|---|
| United States | 96 |
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Avid Radiopharmaceuticals