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This study is designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physician Readers | Experimental | Physician readers will interpret 60 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 |
|---|---|---|
| Inter Rater Reliability | Measure of agreement among readers using a binary visual read method (amyloid positive/negative) calculated using Fleiss' kappa. All scans were read in a blinded fashion without access to clinical information. | Scan acquired 50-60 minutes post injection |
| Percent Agreement with Expert Panel | Individual reader scan results will be compared to the expert panel's consensus rating for each scan. | Scan acquired 50-60 minutes post-injection |
| Measure | Description | Time Frame |
|---|---|---|
| Change in inter reader reliability after application of quantitation software | Evaluate the percent change in inter reader reliability after implementation of quantitation analysis. | Scan acquired 50-60 minutes post injection |
| Change in agreement with expert panel |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Tokyo | 100-0005 | Japan |
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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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The percent change in individual reader agreement with the expert panel's consensus rating will determined after implementation of quantitation analysis. |
| Scan acquired 50-60 minutes post-injection |
| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |