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Assess the Prognostic Usefulness of Flutemetamol (18F) Injection for Identifying Subjects With Amnestic Mild Cognitive Impairment Who Will Convert to Clinically Probable Alzheimer's Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01028053
First Posted: December 9, 2009
Last Update Posted: September 11, 2014
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.
Collaborators:
Medpace, Inc.
i3 Statprobe
i3 Research
Quintiles, Inc.
Information provided by (Responsible Party):
GE Healthcare
Results First Submitted: July 30, 2014  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Diagnostic
Conditions: Mild Cognitive Impairment
Alzheimer's Disease
Intervention: Drug: Flutemetamol (18F) Injection

  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
Flutemetamol (18F) Injection Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.

Participant Flow:   Overall Study
    Flutemetamol (18F) Injection
STARTED   365 
COMPLETED   232 
NOT COMPLETED   133 
Screen Failure                113 
Patient Request                11 
Protocol Violation                1 
Physician Decision                2 
Technical Problem                1 
Terminated by Sponsor                1 
Various reasons                4 



  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
Flutemetamol (18F) Injection Flutemetamol (18F) Injection: All subjects will receive an i.v. dose of (18F) flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of (18F) flutemetamol will be 185 MBq.

Baseline Measures
   Flutemetamol (18F) Injection 
Overall Participants Analyzed 
[Units: Participants]
 232 
Age 
[Units: Years]
Mean (Standard Deviation)
 71.1  (8.62) 
Age 
[Units: Participants]
 
<=18 years   0 
Between 18 and 65 years   63 
>=65 years   169 
Gender 
[Units: Participants]
 
Female   118 
Male   114 
Region of Enrollment 
[Units: Participants]
 
United States   109 
Belgium   13 
Denmark   8 
Finland   15 
Sweden   7 
United Kingdom   80 


  Outcome Measures
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1.  Primary:   Hazard Ratio (HR) by PET Scan Readers for Conversion to Probable Alzheimer’s Disease Based on Visual Image Interpretation.   [ Time Frame: Up to 36 months post flutemetamol administration ]

2.  Secondary:   The of Normal and Abnormal Subjects Who Convert to Probable Alzheimer’s Disease (pAD) Within the Follow up Period.   [ Time Frame: Up to 36 months post flutemetamol administration. ]


  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 NOT 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.


Results Point of Contact:  
Name/Title: Paul Sherwin M.D.
Organization: GE Healthcare
phone: 16095146820
e-mail: Paul.Sherwin@ge.com



Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01028053     History of Changes
Other Study ID Numbers: GE-067-005
First Submitted: December 7, 2009
First Posted: December 9, 2009
Results First Submitted: July 30, 2014
Results First Posted: September 11, 2014
Last Update Posted: September 11, 2014