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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00857415
First Posted: March 6, 2009
Last Update Posted: May 23, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
Results First Submitted: April 6, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition: Alzheimer's Disease
Intervention: Drug: florbetapir F 18

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Autopsy Cohort End-of-life subjects consenting to brain donation at autopsy. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.
Specificity Cohort Younger healthy controls presumed to be devoid of beta-amyloid plaques. Subjects received a single intravenous injection of 370 MBq florbetapir followed by a 10-minute PET scan 50 minutes post-injection.

Participant Flow:   Overall Study
    Autopsy Cohort   Specificity Cohort
STARTED   152   74 
Deceased Within One Year of AV-45 Scan   37   0 [1] 
COMPLETED   35   74 
NOT COMPLETED   117   0 
Image acquisition failure                2                0 
Invalid image or not imaged                3                0 
Subject still living at end of study                110                0 
Deceased with no autopsy                2                0 
[1] Subjects in the specificity cohort were not followed to autopsy



  Baseline Characteristics


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Correlation of Florbetapir-PET Image and Amyloid Plaque Density   [ Time Frame: at autopsy up to 12 months post-scan ]

2.  Primary:   Specificity Analysis   [ Time Frame: 50-60 min after injection ]

3.  Secondary:   Regional Correlation Analysis   [ Time Frame: at autopsy up to 12 months post-scan ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information