Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)
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|ClinicalTrials.gov Identifier: NCT01565382|
Recruitment Status : Completed
First Posted : March 28, 2012
Results First Posted : June 27, 2012
Last Update Posted : June 27, 2012
|Condition or disease||Intervention/treatment||Phase|
|Alzheimer's Disease||Drug: florbetapir F 18||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Evaluation of Physician Training for Interpretation of Florbetapir-PET Scans: Evaluation of Inter-reader Reliability Using Images From Subjects With a Clinical Presentation of AD or MCI|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
- Drug: florbetapir F 18
IV injection, 370MBq (10mCi), single doseOther Names:
- Inter-reader Agreement - Median Kappa Statistic [ Time Frame: 50-60 min after injection ]Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Simple kappa statistics were calculated for each reader versus the other 6 readers. Primary outcome measure was the median kappa of each reader versus the other 6 readers.
- Overall Inter-reader Agreement - Fleiss' Kappa [ Time Frame: 50-60 min after injection ]Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01565382
|Study Director:||Chief Medical Officer||Avid Radiopharmaceuticals|