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

Completed · Phase 3

Conditions studied: Alzheimer's Disease

In brief

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.

Key facts

Study ID

NCT01447719

Run by

Avid Radiopharmaceuticals

People needed

110

Starts

2010-03-01

Expected to finish

2011-07-01

Last updated by the study team

2025-03-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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