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


  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 ]

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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