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This study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid plaque density as measured by histopathological assessment. The study will address the following specific aims:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | No study drug administered in this trial. Study subjects previously dosed with 18F-AV-45 in study 18F-AV-45-A07 (NCT00857415) are followed to autopsy in this extension study. |
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| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity Analysis in All Autopsy Population | Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative). | at autopsy within 24 months of florbetapir PET scan |
| Specificity Analysis in All Autopsy Population | Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative). | at autopsy within 24 months of florbetapir PET scan |
| Correlation of Florbetapir-PET Image and Amyloid Plaque Density | Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | at autopsy within 24 months of florbetapir PET scan |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan | Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative). | at autopsy within 12 months of florbetapir PET scan |
| Measure | Description | Time Frame |
|---|---|---|
| Median Sensitivity and Specificity vs. CERAD Diagnosis | Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria). | at autopsy within 24 months of florbetapir PET scan |
| Individual Reader Results (All Scans With Autopsy) |
Inclusion Criteria:
Subjects are enrolled in this study if they:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Phoenix | Arizona | 85006 | United States | ||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22749065 | Derived | Clark CM, Pontecorvo MJ, Beach TG, Bedell BJ, Coleman RE, Doraiswamy PM, Fleisher AS, Reiman EM, Sabbagh MN, Sadowsky CH, Schneider JA, Arora A, Carpenter AP, Flitter ML, Joshi AD, Krautkramer MJ, Lu M, Mintun MA, Skovronsky DM; AV-45-A16 Study Group. Cerebral PET with florbetapir compared with neuropathology at autopsy for detection of neuritic amyloid-beta plaques: a prospective cohort study. Lancet Neurol. 2012 Aug;11(8):669-78. doi: 10.1016/S1474-4422(12)70142-4. Epub 2012 Jun 28. |
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Demographic results are only provided for primary analysis populations of subjects who came to autopsy. Demographic characteristics for the entire population of 152 subjects are reported with the results of study A07 (NCT00857415).
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| ID | Title | Description |
|---|---|---|
| FG000 | Autopsy Cohort | End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan | Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative). | at autopsy within 12 months of florbetapir PET scan |
Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy. |
| at autopsy within 24 months of florbetapir PET scan |
| Individual Reader Results (Autopsy Within 1 Year of Scan) | Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy. | at autopsy within 12 months of florbetapir PET scan |
| Sun City |
| Arizona |
| 85351 |
| United States |
| Research Site | Little Rock | Arkansas | 72211 | United States |
| Research Site | Irvine | California | 92697 | United States |
| Research Site | Fort Myers | Florida | 33912 | United States |
| Research Site | Miami | Florida | 33137 | United States |
| Research Site | Miami Beach | Florida | 33140 | United States |
| Research Site | Miami Springs | Florida | 33166 | United States |
| Research Site | Orlando | Florida | 32835 | United States |
| Research Site | Sarasota | Florida | 34231 | United States |
| Research Site | St. Petersburg | Florida | 33709 | United States |
| Research Site | West Palm Beach | Florida | 33407 | United States |
| Research Site | Baltimore | Maryland | 21221 | United States |
| Research Site | Hattiesburg | Mississippi | 39401 | United States |
| Research Site | St Louis | Missouri | 63141 | United States |
| Research Site | Albany | New York | 12208 | United States |
| Research Site | New Hyde Park | New York | 11040 | United States |
| Research Site | Durham | North Carolina | 27710 | United States |
| Research Site | Centerville | Ohio | 45459 | United States |
| Research Site | Oklahoma City | Oklahoma | 73112 | United States |
| Research Site | Charleston | South Carolina | 29425 | United States |
| Research Site | Johnson City | Tennessee | 37614 | United States |
| Valid AV-45 Scan Acquired |
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| Deceased <2 Years After AV-45 Scan |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Autopsy Population | Group of subjects with valid images who came to autopsy within 2 years of scan |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Baseline clinical diagnosis | Number | participants |
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| 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 Analysis in All Autopsy Population | Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD (Consortium to Establish a Registry for AD) criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative). | 39 of 59 subjects from all autopsy population had moderate to frequent neuritic plaques at autopsy | Posted | Number | participants | at autopsy within 24 months of florbetapir PET scan |
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| Primary | Specificity Analysis in All Autopsy Population | Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative). | 20 of 59 subjects from the all autopsy population had no or sparse neuritic plaques at autopsy | Posted | Number | participants | at autopsy within 24 months of florbetapir PET scan |
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| Primary | Correlation of Florbetapir-PET Image and Amyloid Plaque Density | Spearman's rank order correlation of the median visual read of the florbetapir-PET image and the amyloid plaque density assessed post-mortem by quantitative immunohistochemistry (IHC) averaged across 6 brain regions (precuneus, parietal cortex, frontal cortex, temporal cortex, posterior cingulate, anterior cingulate). Spearman's rank order correlation ranges from -1 to +1. A value of -1 indicates perfect negative correlation, and a value of +1 indicates a perfect positive correlation. | Posted | Number | 95% Confidence Interval | Correlation coefficient | at autopsy within 24 months of florbetapir PET scan |
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| Secondary | Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan | Sensitivity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative). | 28 of 46 subjects who died within 1 year of scan had moderate to frequent neuritic plaques at autopsy | Posted | Number | participants | at autopsy within 12 months of florbetapir PET scan |
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| Secondary | Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan | Specificity of florbetapir-PET scan to detect moderate to frequent amyloid plaques. Plaque density was calculated using CERAD criteria. Florbetpir-PET scans were read by five independent readers blinded to clinical information using the binary read method (amyloid positive/negative). | 18 of 46 subjects who died within 1 year of scan had no or sparse neuritic plaques at autopsy | Posted | Number | participants | at autopsy within 12 months of florbetapir PET scan |
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| Other Pre-specified | Median Sensitivity and Specificity vs. CERAD Diagnosis | Median sensitivity and specificity for 5 independent readers to detect moderate to frequent amyloid plaques (per CERAD criteria). | Posted | Median | Full Range | percentage of true positives/negatives | at autopsy within 24 months of florbetapir PET scan |
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| Other Pre-specified | Individual Reader Results (All Scans With Autopsy) | Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 39 positive and 20 negative scans based on histopathology at autopsy. | Posted | Number | florbetapir PET scans | at autopsy within 24 months of florbetapir PET scan |
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| Other Pre-specified | Individual Reader Results (Autopsy Within 1 Year of Scan) | Reader results (number of false negatives and number of false positives) for blinded independent readers. There were a total of 28 positive and 18 negative scans based on histopathology at autopsy. | Includes only those subjects with time from scan to autopsy less than one year. | Posted | Number | florbetapir PET scans | at autopsy within 12 months of florbetapir PET scan |
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No adverse events were collected in this study, as this study only followed study A07(NCT01447719) subjects to autopsy. Adverse events are reported with study A07 (NCT00857415).
No adverse events were collected in this study, as this study only followed study A07(NCT01447719) subjects to autopsy. Adverse events are reported with study A07 (NCT00857415).
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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 | Autopsy Cohort | End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection. | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Avid Radiopharmaceuticals | 215-298-0700 | clinicaloperations@avidrp.com |
| ID | Term |
|---|---|
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C545186 | florbetapir |
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| No history of cognitive impairment |
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| Mild cognitive impairment |
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| Title | Denominators | Categories |
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| Sensitivity |
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| Specificity |
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| Title | Denominators | Categories | ||||
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| Reader 1 - False Negatives |
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| Reader 1 - False Positives |
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| Reader 2 - False Negatives |
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| Reader 2 - False Positives |
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| Reader 3 - False Negatives |
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| Reader 3 - False Positives |
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| Reader 4 - False Negatives |
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| Reader 4 - False Positives |
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| Reader 5 - False Negatives |
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| Reader 5 - False Positives |
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