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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00857415
First received: March 5, 2009
Last updated: May 17, 2012
Last verified: May 2012
Results First Received: April 6, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (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
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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.
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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.
Total Total of all reporting groups

Baseline Measures
    Autopsy Cohort     Specificity Cohort     Total  
Number of Participants  
[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
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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 ]
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Measure Type Primary
Measure Title Specificity Analysis
Measure Description Specificity of florbetapir-PET scan in younger healthy controls presumed to be negative for amyloid. Specificity results are reported as the number of subjects who had a negative scan based on majority of 3 blinded readers.
Time Frame 50-60 min after injection  
Safety Issue No  

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.
Per protocol, 27 subjects who were genetic carriers for ApoE e4 or whose genetic status was unknown were excluded from the analysis

Reporting Groups
  Description
Specificity Cohort Younger healthy controls presumed to be devoid of beta-amyloid plaques

Measured Values
    Specificity Cohort  
Number of Participants Analyzed  
[units: participants]
  47  
Specificity Analysis  
[units: participants]
 
Positive for amyloid     0  
Negative for amyloid     47  


Statistical Analysis 1 for Specificity Analysis
Groups [1] Specificity Cohort
Specificity [2] 100
95% Confidence Interval ( 91 to 100 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Proportion of subjects who had a negative scan based on majority of 3 blinded readers
[2] Other relevant estimation information:
  95% CI calculated by Wilson score method



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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