A Phase II Trial of 18F-AV-45 Positron Emission Tomography (PET) Imaging in Healthy Volunteers, Patients With Mild Cognitive Impairment (MCI) and Patients With Alzheimer's Disease (AD)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier:
NCT00702143
First received: June 19, 2008
Last updated: May 8, 2012
Last verified: May 2012
Results First Received: April 6, 2012  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Safety/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
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 Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
MCI Subjects MCI (mild cognitive impairment)
Healthy Controls cognitively normal (healthy) controls

Participant Flow:   Overall Study
    AD Subjects     MCI Subjects     Healthy Controls  
STARTED     45     60     79  
COMPLETED     45     60     78  
NOT COMPLETED     0     0     1  
Lost to Follow-up                 0                 0                 1  



  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
AD Subjects Probable Alzheimer's Disease (AD) according to the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association criteria
MCI Subjects MCI (mild cognitive impairment)
Healthy Controls cognitively normal (healthy) controls
Total Total of all reporting groups

Baseline Measures
    AD Subjects     MCI Subjects     Healthy Controls     Total  
Number of Participants  
[units: participants]
  45     60     79     184  
Age  
[units: years]
Mean ± Standard Deviation
  75.4  ± 9.21     71.7  ± 10.23     69.4  ± 11.04     71.6  ± 10.57  
Gender  
[units: participants]
       
Female     19     33     45     97  
Male     26     27     34     87  
Region of Enrollment  
[units: participants]
       
United States     45     60     79     184  



  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 ]

3.  Secondary:   Proportion of Positive Florbetapir-PET Scans   [ Time Frame: 50-60 min after injection ]


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


No publications provided


Responsible Party: Avid Radiopharmaceuticals
ClinicalTrials.gov Identifier: NCT00702143     History of Changes
Other Study ID Numbers: 18F-AV-45-A05
Study First Received: June 19, 2008
Results First Received: April 6, 2012
Last Updated: May 8, 2012
Health Authority: United States: Food and Drug Administration