Phase II Study of Florbetaben (BAY 94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid in Patients With Probable Alzheimer's Disease Compared to Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT00750282
First received: September 9, 2008
Last updated: June 16, 2014
Last verified: June 2014
Results First Received: June 16, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Alzheimer Disease
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

There were two parts in this study, Part A and Part B. Part A was conducted in Australia, Germany, Switzerland and USA. Subjects were recruited from 17 centers. HVs were age matched to subjects with probable Alzheimer's (AD).

Part B was conducted in Australia, Germany, Japan, Switzerland, and USA, subjects recruited from 22 centers.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Part A screened 214 subjects; 113 AD and 101 HV. There were 63 screen failures (40 for inclusion criteria, 14 withdrew consent, 9 for other reasons) and one dropout prior to receiving study drug.

Part B screened 392 subjects; 204 AD and 188 HV. There were 118 screen failures for similar reasons and 2 dropouts prior to receiving study drug.


Reporting Groups
  Description
Part A Healthy Volunteers Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 megabequerel (MBq) single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions.
Part A Alzheimer Patients Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Part B Healthy Volunteers Florbetaben (BAY94-9172) : Healthy volunteers receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Part B Alzheimer Patients Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions

Participant Flow:   Overall Study
    Part A Healthy Volunteers     Part A Alzheimer Patients     Part B Healthy Volunteers     Part B Alzheimer Patients  
STARTED     69     82     126     148  
COMPLETED     69     81     125     147  
NOT COMPLETED     0     1     1     1  



  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.
  1. dropout in Part A occurred due to pre-treatment AEs.
  2. dropouts in Part B occurred due to withdrawal of consent.

Reporting Groups
  Description
Part A Healthy Volunteers Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Part A Alzheimer Patients Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Part B Healthy Volunteers Florbetaben (BAY94-9172) : Healthy volunteers receiving single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Part B Alzheimer Patients Florbetaben (BAY94-9172) : Patients with probable Alzheimer's disease receiving 300 MBq single injection of investigational medicinal product BAY 94-9172 followed by subsequent PET imaging sessions
Total Total of all reporting groups

Baseline Measures
    Part A Healthy Volunteers     Part A Alzheimer Patients     Part B Healthy Volunteers     Part B Alzheimer Patients     Total  
Number of Participants  
[units: participants]
  69     81     125     147     422  
Age  
[units: participants]
         
<=18 years     0     0     0     0     0  
Between 18 and 65 years     23     19     21     15     78  
>=65 years     46     62     104     132     344  
Age  
[units: years]
Mean ± Standard Deviation
  68.2  ± 6.86     70.7  ± 7.82     70.7  ± 6.30     73.9  ± 7.30     71.4  ± 7.36  
Gender  
[units: participants]
         
Female     39     36     52     73     200  
Male     30     45     73     74     222  
Region of Enrollment  
[units: participants]
         
United States     8     3     22     31     64  
Australia     9     6     11     5     31  
Germany     49     71     63     72     255  
Switzerland     3     1     0     11     15  
Japan     0     0     29     28     57  



  Outcome Measures
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1.  Primary:   Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part A Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth   [ Time Frame: 90 - 110 min after investigational medical product (IMP) injection ]

2.  Primary:   Specificity and Sensitivity of Florbetaben PET Scans Obtained in Part B Using Two Separate Algorithms and the Onsite Clinical Diagnosis as the Standard of Truth.   [ Time Frame: 90 - 110 min after IMP injection ]

3.  Secondary:   Sensitivity and Specificity for All Participants Using Two Additional Imaging Windows for the Visual Assessment   [ Time Frame: 45 - 60 min and 110 - 130 min after IMP injection ]

4.  Secondary:   Kappa Coefficient as a Measure of Agreement Between Readers Concerning the Visual Assessment of Abnormality of the Brain Scan (Based on BAPL Score)   [ Time Frame: 45-60 min, 90-110 min, 110-130 min ]

5.  Secondary:   Standard Uptake Value Ratios for Florbetaben Signal   [ Time Frame: 90-110 min post injection ]


  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


Publications of Results:

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT00750282     History of Changes
Other Study ID Numbers: 311741, 2007-002256-42, 311741
Study First Received: September 9, 2008
Results First Received: June 16, 2014
Last Updated: June 16, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Switzerland: Swissmedic
Australia: Department of Health and Ageing Therapeutic Goods Administration
Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration