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Florbetaben (BAY94-9172) PET (Positron Emission Tomography) Imaging in MCI (Mild Cognitive Impairment) Patients

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ClinicalTrials.gov Identifier: NCT01138111
Recruitment Status : Completed
First Posted : June 7, 2010
Results First Posted : June 25, 2014
Last Update Posted : June 25, 2014
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Alzheimer Disease
Amyloid Beta-Protein
Intervention: Drug: Florbetaben (BAY94-9172)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
A total of 71 patients were screened at one study center in Australia. The first subject's consent was obtained on 02 JUN 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
26 subjects were screen failures and did not have study drug administered.

Reporting Groups
  Description
MCI Subjects Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection of 300 megaBecqerels (MBq) florbetaben, at baseline, at 12 and 24 months

Participant Flow:   Overall Study
    MCI Subjects
STARTED   45 
COMPLETED   36 
NOT COMPLETED   9 
Withdrawal by Subject                5 
Adverse Event                1 
Death                1 
Lost to Follow-up                2 



  Baseline Characteristics

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 enrolled subjects who received at least one florbetaben (BAY94-9172) injection

Reporting Groups
  Description
MCI Subjects Subjects with mild cognitive impairment (MCI) receiving florbetaben (BAY94-9172) : single intravenous injection 2 mL to 10 mL, at baseline, at 12 and 24 months

Baseline Measures
   MCI Subjects 
Overall Participants Analyzed 
[Units: Participants]
 45 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   6 
>=65 years   39 
Age 
[Units: Years]
Mean (Standard Deviation)
 72.7  (6.5) 
Gender 
[Units: Participants]
 
Female   16 
Male   29 
Region of Enrollment 
[Units: Participants]
 
Australia   45 


  Outcome Measures

1.  Primary:   Quantitative Assessment of Neocortical SUVRs (Mean Standard Uptake Value Ratios) as a Measure of Florbetaben Uptake   [ Time Frame: 1 scanning period post injection to be evaluated at baseline, 12 months and 24 months ]

2.  Secondary:   Number of Normal and Abnormal Scans in Patients With MCI Progressing to AD and Those Who do Not Progress Based on a Threshold of Neocortical SUVR=1.4   [ Time Frame: 1 scanning period post injection to be evaluated at baseline, at 12 months and at 24 months ]

3.  Secondary:   Number and Proportion of Normal and Abnormal Scans Based on Brain ß-amyloid Plaque Load (BAPL) in Subjects With MCI Converting to AD and Those Who do Not Progress   [ Time Frame: 2 scanning periods post injection to be evaluated each at baseline, at 12 months, and at 24 months ]

4.  Secondary:   Sensitivity/Specificity/Negative Predictive Value (NPV)/Positive Predictive Value (PPV) at Baseline, 12, and 24 Months in the Detection of Significant Brain ß-amyloid Plaque Load in Patients With MCI Progressing to AD Compared to Those Who do Not Progress   [ Time Frame: 2 scanning periods post injection to be evaluated at baseline ]


  Serious Adverse Events


  Other Adverse Events


  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
No text entered.


  More Information

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: Juergen Hirschfeld, Senior Director Regulatory Affairs
Organization: Piramal Imaging
phone: +49 30 461 1246 15
e-mail: juergen.hirschfeld@piramal.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01138111     History of Changes
Other Study ID Numbers: 312043
First Submitted: April 1, 2010
First Posted: June 7, 2010
Results First Submitted: January 10, 2014
Results First Posted: June 25, 2014
Last Update Posted: June 25, 2014