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Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Independent, blinded reader trainees | Experimental | Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Inter-reader Agreement - Median Kappa Statistic | Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers. | 50-60 min after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Overall Inter-reader Agreement - Fleiss' Kappa | Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons. | 50-60 min after injection |
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Participants:
Inclusion Criteria AD:
Inclusion Criteria MCI:
Exclusion Criteria:
Readers:
•Private nuclear medicine physicians with no prior training in reading florbetapir-PET scans
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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 40 scans obtained from 25 mild cognitive impairment (MCI) subjects and 15 Alzheimer's Disease (AD) subjects randomly selected from Study A05 (NCT00702143).
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| ID | Title | Description |
|---|---|---|
| FG000 | A05 Florbetapir-PET Scans | Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | A05 Florbetapir-PET Scans | Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143) |
| 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 | Inter-reader Agreement - Median Kappa Statistic | Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers. | Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads) as either amyloid positive or negative. | Posted | Number | median kappa | 50-60 min after injection | florbetapir PET scan reads | florbetapir PET scan reads |
|
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Adverse Events were not collected for this study. No subjects received florbetapir in this study. This study consisted of rereads of scans previously acquired in another clinical study (A05[NCT00702143]).
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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 | A05 Florbetapir-PET Scans | Subjects who received a valid florbetapir-PET scan in Study A05 (NCT00702143) |
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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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|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| florbetapir PET scan reads |
|
|
| Secondary | Overall Inter-reader Agreement - Fleiss' Kappa | Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons. | Seven private practice nuclear medicine physicians with no prior training in reading florbetapir-PET scans each rated 40 florbetapir-PET scans (7 readers x 40 scans = 280 scan reads) as either amyloid positive or negative. | Posted | Number | Fleiss' kappa | 50-60 min after injection | florbetapir PET scans | florbetapir PET scans |
|
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| 0 |
| 0 |
| 0 |
| 0 |
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| D024801 |
| Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |