Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07
This study has been completed.
Sponsor:
Avid Radiopharmaceuticals
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01447719
First received: May 20, 2011
Last updated: May 17, 2012
Last verified: May 2012
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Purpose
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:
- To expand the number of subjects included in the A07 (NCT00857415) trial correlation analysis (measuring the correlation between the global visual rating of brain amyloid plaque density on an independent blinded read of the florbetapir F 18 PET scan and the cortical amyloid plaque density at autopsy as assessed by histopathology for subjects in the autopsy cohort).
- To determine the sensitivity and specificity of an independent blinded visual read assessment of the florbetapir F 18 PET scan (Aβ+ or Aβ-) versus the final blinded neuropathological assessment made at autopsy.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: florbetapir F 18 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07 |
Resource links provided by NLM:
Genetics Home Reference related topics:
Alzheimer disease
Drug Information available for:
Florbetapir F-18
U.S. FDA Resources
Further study details as provided by Avid Radiopharmaceuticals:
Primary Outcome Measures:
- Sensitivity Analysis in All Autopsy Population [ Time Frame: at autopsy within 24 months of florbetapir PET scan ] [ Designated as safety issue: No ]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).
- Specificity Analysis in All Autopsy Population [ Time Frame: at autopsy within 24 months of florbetapir PET scan ] [ Designated as safety issue: No ]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).
- Correlation of Florbetapir-PET Image and Amyloid Plaque Density [ Time Frame: at autopsy within 24 months of florbetapir PET scan ] [ Designated as safety issue: No ]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.
Secondary Outcome Measures:
- Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan [ Time Frame: at autopsy within 12 months of florbetapir PET scan ] [ Designated as safety issue: No ]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).
- Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan [ Time Frame: at autopsy within 12 months of florbetapir PET scan ] [ Designated as safety issue: No ]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).
| Enrollment: | 110 |
| Study Start Date: | March 2010 |
| Study Completion Date: | July 2011 |
| Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
Intervention Details:
-
Drug: florbetapir F 18
- 18F-AV-45
- Amyvid
- florbetapir
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.
Other Names:
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
Subjects are enrolled in this study if they:
- Met entrance criteria and were enrolled and imaged in trial 18F-AV-45-A07 (NCT00857415)
- Gave informed consent for the 18F-AV-45-A07 (NCT00857415) study procedures and brain donation consistent with the legal requirements of the State in which they are enrolled and the State in which they die
- Consent to participate in the 18F-AV-45-A16 (NCT01447719) extension protocol, if required by the IRB
- Reconfirm their consent to a research brain autopsy, if required by the IRB.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01447719
Locations
| United States, Arizona | |
| Research Site | |
| Phoeniz, Arizona, United States, 85006 | |
| Research Site | |
| Sun City, Arizona, United States, 85351 | |
| United States, Arkansas | |
| Research Site | |
| Little Rock, Arkansas, United States, 72211 | |
| United States, California | |
| Research Site | |
| Irvine, California, United States, 92697 | |
| United States, Florida | |
| Research Site | |
| Fort Myers, Florida, United States, 33912 | |
| Research Site | |
| Miami, Florida, United States, 33137 | |
| Research Site | |
| Miami Beach, Florida, United States, 33140 | |
| Research Site | |
| Miami Springs, Florida, United States, 33166 | |
| Research Site | |
| Orlando, Florida, United States, 32835 | |
| Research Site | |
| Sarasota, Florida, United States, 34231 | |
| Research Site | |
| St. Petersburg, Florida, United States, 33709 | |
| Research Site | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Maryland | |
| Research Site | |
| Baltimore, Maryland, United States, 21221 | |
| United States, Mississippi | |
| Research Site | |
| Hattiesburg, Mississippi, United States, 39401 | |
| United States, Missouri | |
| Research Site | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New York | |
| Research Site | |
| Albany, New York, United States, 12208 | |
| Research Site | |
| New Hyde Park, New York, United States, 11040 | |
| United States, North Carolina | |
| Research Site | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Research Site | |
| Centerville, Ohio, United States, 45459 | |
| United States, Oklahoma | |
| Research Site | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, South Carolina | |
| Research Site | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Research Site | |
| Johnson City, Tennessee, United States, 37614 | |
Sponsors and Collaborators
Avid Radiopharmaceuticals
More Information
No publications provided
| Responsible Party: | Avid Radiopharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT01447719 History of Changes |
| Other Study ID Numbers: | 18F-AV-45-A16 |
| Study First Received: | May 20, 2011 |
| Results First Received: | April 6, 2012 |
| Last Updated: | May 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 16, 2013