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Clinical Evaluation of Florbetapir F 18 (18F-AV-45)

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ClinicalTrials.gov Identifier: NCT01518374
Recruitment Status : Completed
First Posted : January 26, 2012
Results First Posted : June 14, 2018
Last Update Posted : June 14, 2018
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Alzheimer Disease
Mild Cognitive Impairment
Neurodegenerative Diseases
Intervention: Drug: Florbetapir F 18

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
All enrolled subjects who received an injection of florbetapir and completed safety assessment were considered to have completed the study.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
This was a standardized imaging protocol designed to support companion studies where amyloid imaging was used as a biomarker in longitudinal studies of aging or studies of biomarkers for neurodegenerative diseases. Subjects had to meet additional inclusion/exclusion criteria for the companion protocol before being injected and imaged under A14.

Reporting Groups
  Description
Florbetapir-PET Scans Florbetapir F 18: 370 MBq (10 mCi)

Participant Flow:   Overall Study
    Florbetapir-PET Scans
STARTED   1768 
COMPLETED   1761 
NOT COMPLETED   7 
Withdrawal by Subject                2 
Protocol Violation                3 
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.
No text entered.

Reporting Groups
  Description
Florbetapir-PET Scans Florbetapir F 18: 370 MBq (10 mCi)

Baseline Measures
   Florbetapir-PET Scans 
Overall Participants Analyzed 
[Units: Participants]
 1768 
Age [1] 
[Units: Years]
Mean (Standard Deviation)
 
Participants Analyzed   1762 
   68.3  (13.43) 
[1] 6 participants did not have baseline age in the database
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Participants Analyzed   1768 
Female      920  52.0% 
Male      848  48.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
 
Participants Analyzed   1768 
American Indian or Alaska Native      7   0.4% 
Asian      28   1.6% 
Native Hawaiian or Other Pacific Islander      0   0.0% 
Black or African American      233  13.2% 
White      1487  84.1% 
More than one race      0   0.0% 
Unknown or Not Reported      13   0.7% 
Region of Enrollment 
[Units: Participants]
 
United States   
Participants Analyzed   1768 
United States   1768 


  Outcome Measures

1.  Primary:   Safety Assessment   [ Time Frame: 48 hours ]


  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 less than or equal to 60 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



Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01518374     History of Changes
Other Study ID Numbers: 18F-AV-45-A14
First Submitted: July 20, 2011
First Posted: January 26, 2012
Results First Submitted: May 16, 2018
Results First Posted: June 14, 2018
Last Update Posted: June 14, 2018