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This study will evaluate whether the addition of quantitation as an adjunct to visual interpretations significantly improves the accuracy of Amyvid scan interpretation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician Readers | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Florbetapir (18F) | Drug | No Florbetapir (18F) will be administered in this study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Scan acquired 50-60 minutes post injection |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Leiden | 2316XC | Netherlands |
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| ID | Title | Description |
|---|---|---|
| FG000 | Florbetapir PET Scans | No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Florbetapir PET Scans | No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Number | Net Reclassification Index | Scan acquired 50-60 minutes post injection |
|
No subjects received florbetapir in this study. This study consisted of re-reads of scans previously acquired in other clinical studies (A16, and A17).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Florbetapir PET Scans | No subjects were enrolled in this study. Readers interpreted 96 Florbetapir scans from subjects enrolled in previous studies (A16[NCT01447719] and A17[NCT01400425]). Scans used in the study included 46 scans with autopsy (A16) and 50 randomly selected non-autopsy scans (A17). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-298-0700 | clinicaloperations@avidrp.com |
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| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
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| Scan acquired 50-60 minutes post injection |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| OG000 |
| Physician Readers |
All 21 physician readers. |
|
|
|
| Secondary | 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. | Posted | Number | 95% Confidence Interval | Fleiss Kappa | Scan acquired 50-60 minutes post injection |
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|
| 0 |
| 0 |
| 0 |
| 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
|
| Change in Kappa |
|
| Monte Carlo test |
| 0.1229 |
| 2-Sided |
| No |
| Superiority or Other |
| Evaluate whether the VisQ interpretation significantly improves the reliability of Amyvid Scan interpretation. | Monte Carlo test | 0.0260 | 2-Sided | No | Superiority or Other |