Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07
1 other identifier
interventional
110
1 country
22
Brief Summary
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:
- 1.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).
- 2.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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2010
Shorter than P25 for phase_3
22 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 20, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedFirst Posted
Study publicly available on registry
October 6, 2011
CompletedResults Posted
Study results publicly available
May 7, 2012
CompletedMarch 21, 2025
March 1, 2025
1 year
May 20, 2011
April 6, 2012
March 7, 2025
Conditions
Outcome Measures
Primary Outcomes (3)
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
Secondary Outcomes (2)
Sensitivity Analysis in Subjects With Autopsy Within 1 Year of Scan
at autopsy within 12 months of florbetapir PET scan
Specificity Analysis in Subjects With Autopsy Within 1 Year of Scan
at autopsy within 12 months of florbetapir PET scan
Other Outcomes (3)
Median Sensitivity and Specificity vs. CERAD Diagnosis
at autopsy within 24 months of florbetapir PET scan
Individual Reader Results (All Scans With Autopsy)
at autopsy within 24 months of florbetapir PET scan
Individual Reader Results (Autopsy Within 1 Year of Scan)
at autopsy within 12 months of florbetapir PET scan
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (22)
Research Site
Phoenix, Arizona, 85006, United States
Research Site
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
Related Publications (1)
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. Erratum In: Lancet Neurol. 2012 Aug;11(8):658.
PMID: 22749065DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Avid Radiopharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2011
First Posted
October 6, 2011
Study Start
March 1, 2010
Primary Completion
March 1, 2011
Study Completion
July 1, 2011
Last Updated
March 21, 2025
Results First Posted
May 7, 2012
Record last verified: 2025-03