Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01020838
First received: November 16, 2009
Last updated: March 13, 2015
Last verified: March 2015
Results First Received: February 2, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Alzheimer Disease
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
Subjects were screened at 15 study centers in Australia, Germany, France, Japan, and the U.S.

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
All Study Participants All patients enrolling into the study

Participant Flow:   Overall Study
    All Study Participants  
STARTED     218  
Safety Analysis Set     216 [1]
Interim Analysis Set (Primary Efficacy)     41 [2]
Final Analysis Set (Whole Brain)     97 [3]
First Annual Repeat Injection     91 [4]
Second Annual Repeat Injection     34 [5]
COMPLETED     35  
NOT COMPLETED     183  
Death                 90  
Adverse Event                 1  
Withdrawal by Subject                 9  
Lost to Follow-up                 6  
Most common: Study ended by sponsor                 77  
[1] Two patients were excluded from this population because injection of florbetaben was not done.
[2] Primary efficacy analysis of initial study period (tissue-scan matched regional analysis)
[3] Final analysis set comparing PET scans with different histopathological evaluations.
[4] Patients returning for first follow-up administration and PET-scan.
[5] Patients returning for second follow-up administration and PET-scan.



  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.
Participants in the safety analysis set were treated with study drug.

Reporting Groups
  Description
Safety Analysis Set All study participants who received any amount of florbetaben were included in the safety analysis set.

Baseline Measures
    Safety Analysis Set  
Number of Participants  
[units: participants]
  216  
Age  
[units: years]
Mean ± Standard Deviation
  74.4  ± 15.4  
Gender  
[units: participants]
 
Female     104  
Male     112  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     3  
Not Hispanic or Latino     213  
Unknown or Not Reported     0  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     0  
Asian     55  
Native Hawaiian or Other Pacific Islander     0  
Black or African American     2  
White     159  
More than one race     0  
Unknown or Not Reported     0  
BMI (kg/m^2)  
[units: kg/m^2]
Mean ± Standard Deviation
  23.617  ± 5.213  
Body weight  
[units: kg]
Mean ± Standard Deviation
  64.95  ± 18.44  
Height  
[units: cm]
Mean ± Standard Deviation
  164.70  ± 12.34  
Baseline clinical diagnosis  
[units: participants]
 
Alzheimer's Disease     137  
Dementia with Lewy bodies     5  
Other dementia subject     31  
Healthy volunteers     32  
Healthy negative control     11  



  Outcome Measures
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1.  Primary:   Sensitivity and Specificity of the Majority Read of Visual Assessment of Tracer Uptake Compared to Histological Verification of the Presence or Absence of Cerebral Beta-amyloid in Postmortem Specimens   [ Time Frame: 90-110 minutes post injection (PET image acquisition) ]

2.  Secondary:   Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification With Bielschowsky Silver Staining (SOT 1).   [ Time Frame: 90-110 minutes post injection (PET image acquisition) ]

3.  Secondary:   Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With Histopathological Verification With Bielschowsky Silver Staining and Immunohistochemistry (SOT 2).   [ Time Frame: 90-110 minutes post injection (PET image acquisition) ]

4.  Secondary:   Sensitivity and Specificity of the Majority Read "Whole Brain" Visual Assessment in Detecting/Excluding Cerebral Neuritic β-amyloid Plaques Compared With the Histopathological Verification According to CERAD Criteria (SOT 3).   [ Time Frame: 90-110 minutes post injection (PET image acquisition) ]

5.  Secondary:   Sensitivity and Specificity of the Subject Level Composite SUVR Calculated Based on Pathology Results.   [ Time Frame: 90-110 minutes post injection (PET image acquisition) ]

6.  Secondary:   Subject Level Composite SUVRs by SOT for Baseline and Available Follow-Up Scans   [ Time Frame: 90-110 minutes post injection (PET image acquisition) ]


  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: NCT01020838     History of Changes
Other Study ID Numbers: 14595, 2009-012569-79
Study First Received: November 16, 2009
Results First Received: February 2, 2015
Last Updated: March 13, 2015
Health Authority: Australia: Human Research Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration