Phase II Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT00928304
First received: June 24, 2009
Last updated: January 29, 2014
Last verified: January 2014
Results First Received: December 9, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Down Syndrome
Amyloid Beta-protein
Intervention: Drug: Florbetaben (BAY94-9172)

  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
The study was conducted at two sites in the US.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 130 subjects were screened. 21 subjects were considered as screen failures and were not enrolled into the study. 9 subjects did not meet the inclusion/exclusion criteria. 10 subjects withdrew their consent. 1 subject was lost to follow-up and 1 subjected exceeded the weight limit for the camera.

Reporting Groups
  Description
Down Syndrome Group 39 Down Syndrome subjects received Florbetaben (BAY94-9172) : 300 megabecquerels (MBq) single IV injection of 2 to 10 mL
Healthy Volunteer Group 70 healthy volunteer subjects received Florbetaben (BAY94-9172): 300 MBq single IV injection of 2 to 10 mL

Participant Flow:   Overall Study
    Down Syndrome Group     Healthy Volunteer Group  
STARTED     39     70  
COMPLETED     39     70  
NOT COMPLETED     0     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.
All Down Syndrome subjects and healthy volunteers enrolled into the study were included in the Baseline Analysis Population

Reporting Groups
  Description
Subjects Enrolled in Study All Down Syndrome and healthy volunteer subjects

Baseline Measures
    Subjects Enrolled in Study  
Number of Participants  
[units: participants]
  109  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     109  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
 
Down Syndrome Group     46.3  ± 4.7  
Healthy Volunteer Group     27.7  ± 5.1  
Gender  
[units: participants]
 
Female     60  
Male     49  
Region of Enrollment  
[units: participants]
 
United States     109  



  Outcome Measures
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1.  Primary:   Sensitivity of the Independent Visual Assessment of Detecting Cerebral Amyloid-beta in Individuals With Down Syndrome and Specificity in Subjects Without Down Syndrome   [ Time Frame: 100-120 min ]

2.  Secondary:   Sensitivity Results in the Down Syndrome Age Subgroups   [ Time Frame: 100 - 120 min ]

3.  Secondary:   Quantitative Parameters Standard Uptake Value Ratio   [ Time Frame: 100 - 120 min p.i. ]

4.  Secondary:   Consistency Between Visual and Quantitative Efficacy   [ Time Frame: 100 - 120 min ]


  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
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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.


Results Point of Contact:  
Name/Title: Dr. Juergen Hirschfeld
Organization: Piramal Imaging
phone: 49 30 461 1246 15
e-mail: juergen.hirschfeld@piramal.com


No publications provided


Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT00928304     History of Changes
Other Study ID Numbers: 14311
Study First Received: June 24, 2009
Results First Received: December 9, 2013
Last Updated: January 29, 2014
Health Authority: United States: Food and Drug Administration