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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:
ClinicalTrials.gov Identifier:
NCT01662882
First Posted: August 13, 2012
Last Update Posted: September 19, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
Results First Submitted: July 16, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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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  More Information