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This study will re-read 10-minute positron emission tomography (PET) scans acquired in previous clinical studies of AV-45 at 30 and 50 minutes after injection and compare the results.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| florbetapir F 18 | Drug | IV injection, 111 or 370MBq (3 or 10mCi), single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation | Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan. | Scans acquired 30-40 min and 50-60 min after injection |
| Measure | Description | Time Frame |
|---|---|---|
| Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation | Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic. |
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Eligibility for subjects scans to be used in this study is determined by subject's eligibility/enrollment in Study A01(NCT01565291) or A03(NCT01565330).
Inclusion Criteria (AD group):
Inclusion Criteria (A01[NCT01565291] healthy volunteer group):
50 years of age, inclusive
Inclusion Criteria (A03[NCT01565330] healthy volunteer group):
Exclusion Criteria (both groups):
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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 Subject Scans | 22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Subject Scans | 22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03 |
| 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 | Percent Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Qualitative Evaluation | Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported as amyloid positive or amyloid negative. Results show the percentage of agreement between the majority read of 30-40 min scan and the majority read of the 50-60 min scan. | Posted | Number | percentage of agreement | Scans acquired 30-40 min and 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 other clinical studies (A01,A03).
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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 Subject Scans | 22 florbetapir-PET scans obtained in Study A01 and and 19 scans obtained in A03 |
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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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| Scans acquired 30-40 min and 50-60 min post-injection |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
|
|
| Secondary | Agreement of Interpretation Between 30-40 and 50-60 Min Reads - Semi-quantitative Evaluation | Three independent readers blinded to subject identification, subject diagnosis, subject demographics and PET scan time points post-injection read each scan and reported the results using a 5-point scale (0=no amyloid; 4=high levels of amyloid deposition). Results are reported as a weighted kappa statistic. | Posted | Number | 95% Confidence Interval | weighted kappa | Scans acquired 30-40 min and 50-60 min 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 |