Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07

Alzheimer's Disease Clinical Trial

Official title:

Autopsy Follow-up of Subjects Previously Imaged With Florbetapir F 18 (18F-AV-45) PET in Trial 18F-AV-45-A07

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01447719
• Other study ID #: 18F-AV-45-A16
• Status: Completed
• Phase: Phase 3
• First received: May 20, 2011
• Last updated: May 17, 2012
• Start date: March 2010
• Est. completion date: July 2011

Study information

• Verified date: May 2012
• Source: Avid Radiopharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: July 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

Drug:
• florbetapir F 18
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.

Locations

Country	Name	City	State
United States	Research Site	Albany	New York
United States	Research Site	Baltimore	Maryland
United States	Research Site	Centerville	Ohio
United States	Research Site	Charleston	South Carolina
United States	Research Site	Durham	North Carolina
United States	Research Site	Fort Myers	Florida
United States	Research Site	Hattiesburg	Mississippi
United States	Research Site	Irvine	California
United States	Research Site	Johnson City	Tennessee
United States	Research Site	Little Rock	Arkansas
United States	Research Site	Miami	Florida
United States	Research Site	Miami Beach	Florida
United States	Research Site	Miami Springs	Florida
United States	Research Site	New Hyde Park	New York
United States	Research Site	Oklahoma City	Oklahoma
United States	Research Site	Orlando	Florida
United States	Research Site	Phoeniz	Arizona
United States	Research Site	Sarasota	Florida
United States	Research Site	St. Louis	Missouri
United States	Research Site	St. Petersburg	Florida
United States	Research Site	Sun City	Arizona
United States	Research Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Avid Radiopharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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).	at autopsy within 24 months of florbetapir PET scan	No
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).	at autopsy within 24 months of florbetapir PET scan	No
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.	at autopsy within 24 months of florbetapir PET scan	No
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).	at autopsy within 12 months of florbetapir PET scan	No
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).	at autopsy within 12 months of florbetapir PET scan	No