A Phase II Trial of Florbetapir (18F) Positron Emission Tomography (PET) Imaging in Japan of Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01662882
First received: August 7, 2012
Last updated: July 16, 2013
Last verified: July 2013
Results First Received: July 16, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Intervention: Drug: florbetapir (18F)

  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
AD Subjects florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
Healthy Controls florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
MCI Subjects

MCI (mild cognitive impairment)

florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose


Participant Flow:   Overall Study
    AD Subjects     Healthy Controls     MCI Subjects  
STARTED     15     18     15  
COMPLETED     15     18     15  
NOT COMPLETED     0     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.
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Reporting Groups
  Description
AD Subjects florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
Healthy Controls florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
MCI Subjects

MCI (mild cognitive impairment)

florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose

Total Total of all reporting groups

Baseline Measures
    AD Subjects     Healthy Controls     MCI Subjects     Total  
Number of Participants  
[units: participants]
  15     18     15     48  
Age  
[units: participants]
Mean ± Standard Deviation
  73.3  ± 7.80     70.0  ± 11.15     73.3  ± 5.09     72.1  ± 8.57  
Gender  
[units: participants]
       
Female     14     10     6     30  
Male     1     8     9     18  
Region of Enrollment  
[units: participants]
       
Japan     15     18     15     48  



  Outcome Measures
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1.  Primary:   Qualitative Amyloid Image Assessment   [ Time Frame: 50-60 min after injection ]
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Measure Type Primary
Measure Title Qualitative Amyloid Image Assessment
Measure Description Five readers blinded to all clinical information classified florbetapir-Positron Emission Tomography (PET) images as either positive for amyloid or negative for amyloid. The majority read was the primary efficacy endpoint for the qualitative evaluation.
Time Frame 50-60 min after injection  
Safety Issue No  

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.
No text entered.

Reporting Groups
  Description
AD Subjects florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
MCI Subjects

MCI (mild cognitive impairment)

florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose

Healthy Controls florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose

Measured Values
    AD Subjects     MCI Subjects     Healthy Controls  
Number of Participants Analyzed  
[units: participants]
  15     15     18  
Qualitative Amyloid Image Assessment  
[units: participants]
     
Positive for amyloid     12     5     3  
Negative for amyloid     3     10     15  


Statistical Analysis 1 for Qualitative Amyloid Image Assessment
Groups [1] AD Subjects vs. MCI Subjects
Method [2] Fisher Exact
P Value [3] 0.0253
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 2 for Qualitative Amyloid Image Assessment
Groups [1] AD Subjects vs. Healthy Controls
Method [2] Fisher Exact
P Value [3] 0.0004
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 3 for Qualitative Amyloid Image Assessment
Groups [1] MCI Subjects vs. Healthy Controls
Method [2] Fisher Exact
P Value [3] 0.4184
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.

Statistical Analysis 4 for Qualitative Amyloid Image Assessment
Groups [1] All groups
Method [2] Fisher Exact
P Value [3] 0.0008
[1] Additional details about the analysis, such as null hypothesis and power calculation:
  Fisher exact test comparing the proportion of amyloid positive subjects between clinical diagnosis groups.
[2] Other relevant method information, such as adjustments or degrees of freedom:
  No text entered.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
  No text entered.



2.  Primary:   Mean Cortical to Cerebellum SUVR   [ Time Frame: 50-60 min after 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: 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: NCT01662882     History of Changes
Other Study ID Numbers: 18F-AV-45-J05, I6E-AV-AVBB
Study First Received: August 7, 2012
Results First Received: July 16, 2013
Last Updated: July 16, 2013
Health Authority: Japan: Ministry of Health, Labor and Welfare
Japan: Pharmaceuticals and Medical Devices Agency