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A Phase II Trial of Florbetapir (18F) Positron Emission Tomography (PET) Imaging in Japan of Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT01662882
First received: August 7, 2012
Last updated: July 16, 2013
Last verified: July 2013
Results First Received: July 16, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Conditions: Alzheimer's Disease
Mild Cognitive Impairment
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
No text entered.

Reporting Groups
  Description
AD Subjects florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
Healthy Controls florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
MCI Subjects

MCI (mild cognitive impairment)

florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose


Participant Flow:   Overall Study
    AD Subjects     Healthy Controls     MCI Subjects  
STARTED     15     18     15  
COMPLETED     15     18     15  
NOT COMPLETED     0     0     0  



  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
AD Subjects florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
Healthy Controls florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
MCI Subjects

MCI (mild cognitive impairment)

florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose

Total Total of all reporting groups

Baseline Measures
    AD Subjects     Healthy Controls     MCI Subjects     Total  
Number of Participants  
[units: participants]
  15     18     15     48  
Age  
[units: participants]
Mean ± Standard Deviation
  73.3  ± 7.80     70.0  ± 11.15     73.3  ± 5.09     72.1  ± 8.57  
Gender  
[units: participants]
       
Female     14     10     6     30  
Male     1     8     9     18  
Region of Enrollment  
[units: participants]
       
Japan     15     18     15     48  



  Outcome Measures
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1.  Primary:   Qualitative Amyloid Image Assessment   [ Time Frame: 50-60 min after injection ]

2.  Primary:   Mean Cortical to Cerebellum SUVR   [ Time Frame: 50-60 min after injection ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   0%  

Reporting Groups
  Description
AD Subjects florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose
MCI Subjects

MCI (mild cognitive impairment)

florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose

Healthy Controls florbetapir (18F) : IV injection, 370 MBq(10mCi), single dose

Other Adverse Events
    AD Subjects     MCI Subjects     Healthy Controls  
Total, other (not including serious) adverse events        
# participants affected / at risk     0/15     1/15     5/18  
Eye disorders        
Vision blurred * 1      
# participants affected / at risk     0/15 (0.00%)     0/15 (0.00%)     1/18 (5.56%)  
# events     0     0     1  
Gastrointestinal disorders        
Nausea * 1      
# participants affected / at risk     0/15 (0.00%)     0/15 (0.00%)     1/18 (5.56%)  
# events     0     0     1  
General disorders        
Fatigue * 1      
# participants affected / at risk     0/15 (0.00%)     0/15 (0.00%)     1/18 (5.56%)  
# events     0     0     1  
Malaise * 1      
# participants affected / at risk     0/15 (0.00%)     0/15 (0.00%)     1/18 (5.56%)  
# events     0     0     1  
Vessel puncture site pain * 1      
# participants affected / at risk     0/15 (0.00%)     0/15 (0.00%)     1/18 (5.56%)  
# events     0     0     1  
Investigations        
Blood pressure increased † 1      
# participants affected / at risk     0/15 (0.00%)     1/15 (6.67%)     1/18 (5.56%)  
# events     0     1     1  
Musculoskeletal and connective tissue disorders        
Back pain * 1      
# participants affected / at risk     0/15 (0.00%)     1/15 (6.67%)     0/18 (0.00%)  
# events     0     1     0  
Nervous system disorders        
Headache * 1      
# participants affected / at risk     0/15 (0.00%)     0/15 (0.00%)     1/18 (5.56%)  
# events     0     0     1  
Skin and subcutaneous tissue disorders        
Dermatitis diaper * 1      
# participants affected / at risk     0/15 (0.00%)     0/15 (0.00%)     1/18 (5.56%)  
# events     0     0     1  
Events were collected by systematic assessment
* Events were collected by non-systematic assessment
1 Term from vocabulary, MedDRA 15.0



  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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