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Effectiveness of Florbetapir (18F) PET Imaging in Changing Patient Management and the Relationship Between Scan Status and Cognitive Decline

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01703702
First received: October 5, 2012
Last updated: July 8, 2016
Last verified: July 2016
Results First Received: April 1, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Alzheimer's Disease
Intervention: Drug: florbetapir (18F)

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
641 patients enrolled in the study. 21 patients withdrew before receiving a florbetapir (F18) PET scan. 620 patients received florbetapir and comprise the Safety Population; 2 patients did not have a valid PET scan. Therefore; 618 patients were randomized to the intervention or control arms and comprise the Efficacy Population.

Reporting Groups
  Description
Intervention

Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.

florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Control

Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months

florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration


Participant Flow:   Overall Study
    Intervention     Control  
STARTED     308     310  
COMPLETED     272     288  
NOT COMPLETED     36     22  



  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.
No text entered.

Reporting Groups
  Description
Intervention

Subjects will receive florbetapir (18F) PET scans and physicians will have immediate access to PET scan results.

florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Control

Subjects will receive florbetapir (18F) PET scans but physicians will be blinded to PET scan results for 12 months

florbetapir (18F): Single i.v. bolus injection of 370MBq (10 mCi) followed by saline flush, 50 minutes prior to imaging, 10 minute image duration

Total Total of all reporting groups

Baseline Measures
    Intervention     Control     Total  
Number of Participants  
[units: participants]
  308     310     618  
Age  
[units: years]
Mean (Standard Deviation)
  73.1  (8.2)     72.7  (7.94)     72.9  (8.07)  
Gender  
[units: participants]
     
Female     142     160     302  
Male     166     150     316  
Region of Enrollment  
[units: participants]
     
United States     112     111     223  
Italy     109     112     221  
France     87     87     174  



  Outcome Measures
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1.  Primary:   Clinical and Diagnostic Change in Patient Management   [ Time Frame: Baseline and 3 months ]

2.  Primary:   Change in ADAS-Cog 11 Total Score   [ Time Frame: Baseline and 12 months ]

3.  Secondary:   Change in Patient's Clinical Diagnosis   [ Time Frame: Baseline and 3 months ]

4.  Secondary:   Change in Diagnostic Confidence   [ Time Frame: Baseline and 3 months ]

5.  Secondary:   Change in Patient Management: Advice/Counseling   [ Time Frame: Baseline and 3 months ]

6.  Secondary:   Change in Caregiver Self-efficacy   [ Time Frame: Baseline and 3 months ]

7.  Secondary:   Change in Patient Management: Individual Categories   [ Time Frame: Baseline and 3 months ]


  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 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 more than 60 days but less than or equal to 180 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
phone: 215-298-0700
e-mail: clinicaloperations@avidrp.com



Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT01703702     History of Changes
Other Study ID Numbers: 18F-AV-45-A18
Study First Received: October 5, 2012
Results First Received: April 1, 2016
Last Updated: July 8, 2016
Health Authority: United States: Food and Drug Administration
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Italy: The Italian Medicines Agency