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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:
Collaborators:
Medpace, Inc.
i3 Statprobe
i3 Research
Quintiles
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01028053
First received: December 7, 2009
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: July 30, 2014  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: 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  
Number of Participants  
[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


No publications provided


Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01028053     History of Changes
Other Study ID Numbers: GE-067-005
Study First Received: December 7, 2009
Results First Received: July 30, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency