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Evaluation of Web-based Training to Educate Physicians in the Methods of Interpreting Florbetapir-PET Scans

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01550549
First received: March 6, 2012
Last updated: May 3, 2012
Last verified: May 2012
History of Changes
Results First Received: April 6, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Neurodegenerative Diseases
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
NO SUBJECTS WERE ENROLLED IN THIS STUDY - this study re-read scans obtained in other clinical studies

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
Florbetapir-PET Scans All subject scans with a valid florbetapir-PET scan

Participant Flow:   Overall Study
    Florbetapir-PET Scans  
STARTED     151  
COMPLETED     151  
NOT COMPLETED     0  



  Baseline Characteristics
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Reporting Groups
  Description
Florbetapir-PET Scans All subjects with a valid florbetapir-PET scan (59 from study A07/A16 and 92 from study A05)

Baseline Measures
    Florbetapir-PET Scans  
Number of Participants  
[units: participants]
 		  151  
Age  
[units: years]
Mean ± Standard Deviation 		  74.9  ± 11.87  
Gender  
[units: participants]
 		 
Female     75  
Male     76  
Region of Enrollment  
[units: participants]
 		 
United States     151  



  Outcome Measures
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1.  Primary:   Inter-rater Reliability   [ Time Frame: Scan acquired 50-60 min post-injection ]
  Show Outcome Measure 1

2.  Secondary:   Sensitivity of Florbetapir-PET to Detect Moderate to Frequent Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)   [ Time Frame: at autopsy, within 2 years of scan ]
  Show Outcome Measure 2

3.  Secondary:   Specificity of Florbetapir-PET to Detect no or Sparse Beta-amyloid Neuritic Plaques (Probable/Definite Alzheimer's Disease)   [ Time Frame: at autopsy, within 2 years of scan ]
  Show Outcome Measure 3

4.  Post-Hoc:   Inter-reader Reliability   [ Time Frame: Scan acquired 50-60 min post-injection ]
  Show Outcome Measure 4

5.  Other Pre-specified:   Median Sensitivity and Specificity vs. CERAD Diagnosis   [ Time Frame: Baseline scan ]
  Show Outcome Measure 5

6.  Post-Hoc:   Individual Reader Results (All Scans With Autopsy)   [ Time Frame: Baseline scan ]
  Show Outcome Measure 6

7.  Post-Hoc:   Individual Reader Results (Autopsy Within 1 Year of Scan)   [ Time Frame: Baseline scan ]
  Show Outcome Measure 7


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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
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Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals
phone: 215-298-0700
e-mail: clinicaloperations@avidrp.com


No publications provided


Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01550549     History of Changes
Other Study ID Numbers: 18F-AV-45-PT01
Study First Received: March 6, 2012
Results First Received: April 6, 2012
Last Updated: May 3, 2012
Health Authority: United States: Food and Drug Administration