Observational Study of Cognitive Outcomes for Subjects Who Have Had Prior PET Amyloid Imaging With Florbetapir F 18 (18F-AV-45)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00857506
First received: March 5, 2009
Last updated: March 26, 2013
Last verified: March 2013
Results First Received: December 31, 2012  
Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Diagnostic
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
Intervention: Drug: florbetapir F 18

  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
All subjects were recruited from participants in study 18F-AV-45-A05 (NCT00702143)

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Alzheimer's Disease Subject's with Alzheimer's Disease were recruited from study 18F-AV-45-A05 (NCT00702143). None of these subjects received additional interventions in study 18F-AV-45-A11.
Mild Cognitive Impairment Subject's with Mild Cognitive Impairment (MCI) were recruited from study 18F-AV-45-A05 (NCT00702143). 36 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.
Cognitively Normal Cognitively Normal (CN) subjects were recruited from study 18F-AV-45-A05 (NCT00702143). 50 of these subjects received a single dose of florbetapir F 18 370 MBq (10 mCi), IV injection at the 24 month time point of study 18F-AV-45-A11 and comprise the safety set discussed in the Adverse Events section.

Participant Flow:   Overall Study
    Alzheimer's Disease     Mild Cognitive Impairment     Cognitively Normal  
STARTED     31     52     69  
COMPLETED     16     37     51  
NOT COMPLETED     15     15     18  



  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
Alzheimer's Disease No text entered.
Mild Cognitive Impairment No text entered.
Cognitively Normal No text entered.
Total Total of all reporting groups

Baseline Measures
    Alzheimer's Disease     Mild Cognitive Impairment     Cognitively Normal     Total  
Number of Participants  
[units: participants]
  31     52     69     152  
Age  
[units: years]
Mean ± Standard Deviation
  76.7  ± 9.23     71.5  ± 10.09     69.8  ± 11.26     71.8  ± 10.73  
Gender  
[units: participants]
       
Female     13     29     41     83  
Male     18     23     28     69  
Region of Enrollment  
[units: participants]
       
United States     31     52     69     152  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change in ADAS-Cog for MCI Subjects   [ Time Frame: Baseline and 36 months ]

2.  Secondary:   Cognitive Decline in MCI Subjects   [ Time Frame: Baseline and 36 months ]

3.  Secondary:   Change in ADAS-Cog in CN and AD Subjects   [ Time Frame: Baseline and 36 months ]

4.  Secondary:   Cognitive Decline in CN and AD Subjects   [ Time Frame: Baseline and 36 months ]

5.  Secondary:   Covariate Adjusted Psychometric Score Change   [ Time Frame: Baseline and 36 months ]

6.  Secondary:   Correlation of Change in ADAS-Cog and SUVR   [ Time Frame: Baseline and 36 months ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Chief Medical Officer
Organization: Avid Radiopharmaceuticals, Inc.
phone: 215-298-0700
e-mail: clinicaloperations@avidrp.com


No publications provided


Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT00857506     History of Changes
Other Study ID Numbers: 18F-AV-45-A11
Study First Received: March 5, 2009
Results First Received: December 31, 2012
Last Updated: March 26, 2013
Health Authority: United States: Food and Drug Administration