We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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


  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

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.
Total Total of all reporting groups

Baseline Measures
   Autopsy Cohort   Specificity Cohort   Total 
Overall Participants Analyzed 
[Units: Participants]
 152   74   226 
Age 
[Units: Years]
Mean (Standard Deviation)
 78.1  (13.35)   26.6  (6.50)   61.3  (26.84) 
Gender 
[Units: Participants]
     
Female   81   26   107 
Male   71   48   119 
Region of Enrollment 
[Units: Participants]
     
United States   152   74   226 


  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
  Hide Limitations and Caveats

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
No text entered.


  More Information