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The purpose of this study is re-read of brain amyloid positron emission tomography (PET) scans acquired in previous florbetapir F 18 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had an autopsy to reveal the subject's true amyloid status.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | IV injection, 370MBq (10mCi), single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque | Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers. | 50-60 min after injection |
| Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque | Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers. | 50-60 min after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Inter-reader Agreement | Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers | 50-60 min after injection |
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Inclusion Criteria (Study A07[NCT00857415]):
Exclusion Criteria (Study A07[NCT00857415]):
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| Name | Affiliation | Role |
|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | Study Director |
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NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies
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| ID | Title | Description |
|---|---|---|
| FG000 | All A07 Autopsy Subjects | Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All A07 Autopsy Subjects | Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07 |
| 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 | Sensitivity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque | Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Sensitivity will be calculated as the percent of true positives (as determined by the reference standard, moderate or frequent amyloid plaque at autopsy) that are correctly identified as amyloid positive by the PET scan read. Reported as the median sensitivity of the nine readers. | 19 of the 35 subjects had moderate or frequent plaques at autopsy | Posted | Median | Full Range | percentage of true positives | 50-60 min after injection |
|
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No subjects received florbetapir in this study. This study consisted of rereads of scans previously acquired in another clinical study (A07).
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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 | All A07 Autopsy Subjects | Subjects who had a valid florbetapir-PET scan and came to autopsy in Study A07 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-798-0700 | 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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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Specificity of Florbetapir PET Scans to Detect Moderate to Frequent Amyloid Plaque | Nine readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Specificity will be calculated as the percent of true negatives (as determined by the reference standard, no or sparse amyloid plaque at autopsy) that are correctly identified as amyloid negative by the PET scan read. Reported as the median specificity of the nine readers. | 16 of the 35 subjects had none or sparse plaques at autopsy | Posted | Median | Full Range | percentage of true negatives | 50-60 min after injection |
|
|
|
| Secondary | Inter-reader Agreement | Percentage of individual scan reads that agreed or disagreed with the majority read across nine readers | 315 scans = 35 subjects x 9 readers | Posted | Number | percentage of scans | 50-60 min after injection | florbetapir PET scan reads | Participants |
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| 0 |
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| 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |