We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
IMPORTANT: Due to the lapse in government funding, the information on this web site may not be up to date, transactions submitted via the web site may not be processed, and the agency may not be able to respond to inquiries until appropriations are enacted. Updates regarding government operating status and resumption of normal operations can be found at opm.gov.

A Study of Florbetapir (18F) in Japanese Healthy Volunteers

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.
ClinicalTrials.gov Identifier: NCT01660815
Recruitment Status : Completed
First Posted : August 9, 2012
Results First Posted : September 19, 2013
Last Update Posted : September 19, 2013
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Condition: Alzheimer's Disease
Intervention: Drug: florbetapir (18F)

  Participant Flow


  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.
No text entered.

Reporting Groups
  Description
Healthy Volunteers

Cognitively normal, healthy volunteers at least 45 years of age.

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


Baseline Measures
   Healthy Volunteers 
Overall Participants Analyzed 
[Units: Participants]
 7 
Age 
[Units: Years]
Mean (Standard Deviation)
 54.4  (5.71) 
Gender 
[Units: Participants]
 
Female   1 
Male   6 
Region of Enrollment 
[Units: Participants]
 
Japan   7 


  Outcome Measures

1.  Primary:   Whole Body Radiation Dosimetry   [ Time Frame: 0-360 minutes ]


  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