Florbetapir F 18 PET Imaging of Beta-amyloid in Parkinson's Disease Patients

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00857532
First received: March 5, 2009
Last updated: February 1, 2013
Last verified: February 2013
Results First Received: November 30, 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: Parkinson'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
Subjects With Parkinson's Disease Subjects with diagnosed Parkinson's Disease received a 370 megabecquerel (MBq) injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.

Participant Flow:   Overall Study
    Subjects With Parkinson's Disease  
STARTED     31  
COMPLETED     31  
NOT COMPLETED     0  



  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
Subjects With Parkinson's Disease Subjects with diagnosed Parkinson's Disease received a 370 MBq injection of florbetapir F 18 followed by a 10 minute PET scan 50 minutes post-injection.

Baseline Measures
    Subjects With Parkinson's Disease  
Number of Participants  
[units: participants]
  31  
Age  
[units: years]
Mean ± Standard Deviation
  71.3  ± 6.72  
Gender  
[units: participants]
 
Female     6  
Male     25  
Region of Enrollment  
[units: participants]
 
United States     31  



  Outcome Measures
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1.  Primary:   Mean Cortical Amyloid Burden   [ Time Frame: 50-60 min after injection ]

2.  Secondary:   Correlation Between Global Amyloid Burden and Clinical Measures of Cognitive Decline.   [ Time Frame: 50-60 min after injection ]

3.  Secondary:   Correlation of Florbetapir SUVR With CSF Biomarker Values   [ Time Frame: 50-60 min after injection ]


  Serious Adverse Events


  Other Adverse Events


  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 more than 60 days but less than or equal to 180 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, Inc.
phone: 215-298-0700
e-mail: clinicaloperations@avidrp.com


No publications provided


Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT00857532     History of Changes
Other Study ID Numbers: 18F-AV-45-A12, 5R43NS063607-02
Study First Received: March 5, 2009
Results First Received: November 30, 2012
Last Updated: February 1, 2013
Health Authority: United States: Food and Drug Administration