Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain

Completed · Phase 3

Conditions studied: Alzheimer's Disease

In brief

The study is designed to test the relationship between measurements of brain amyloid using florbetapir F 18 PET imaging and true levels of amyloid by dissection of the brain at autopsy. Amyloid in the brain is a key feature of Alzheimer's Disease (AD).

Key facts

Study ID

NCT00857415

Run by

Avid Radiopharmaceuticals

People needed

226

Starts

2008-12-01

Expected to finish

2010-05-01

Last updated by the study team

2012-05-22

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may not qualify if…

• Have primary brain tumor, known metastases to the brain, central nervous system (CNS) lymphoma;
• Have any major, focal structural loss of brain matter;
• Are aggressively being treated with life sustaining measures (e.g. currently on respirator; receiving high dose chemotherapy);
• Have a clinically significant infectious disease, including Acquired Immune Deficiency Syndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive test for hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);
• Are receiving any investigational medications, or have participated in a trial with investigational medications within the last 30 days;
• Have ever participated in an experimental study with an amyloid targeting agent (e.g. anti-amyloid immunotherapy, secretase inhibitor);
• Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior to the study imaging session; or
• Are females of childbearing potential who are pregnant or not using adequate contraception.

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Scottsdale, 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 — San Francisco, 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
• Research Site — Bennington, Vermont, United States

Full record on ClinicalTrials.gov

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