Evaluation of Inter-reader Reliability Using Images From Subjects With Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI)

Study Overview
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Brief Summary
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Re-read of brain amyloid scans acquired in previous AV-45 clinical studies by readers trained using updated reading methodology. The scans in this study came from subjects who had Alzheimer's Disease (AD) or Mild Cognitive Impairment (MCI).

Official Title
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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

Conditions
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Alzheimer's Disease

Intervention / Treatment
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* Drug: florbetapir F 18


Participation Criteria
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Eligibility Criteria
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Participants: Inclusion Criteria AD: Male or female >=50 years of age Meet National Institute of Neurological and Communicative Disorders and Stroke (NINCDS) criteria for probable AD with Mini-Mental State Examination (MMSE) score of 10-24 Inclusion Criteria MCI: Male or female >=50 years of age Have a Clinical Dementia Rating (CDR) of 0.5 MMSE >24 Exclusion Criteria: Have a history or current diagnosis of other neurologic disease Have had or currently have a diagnosis of other neurodegenerative disease Have participated in experimental therapy targeted to amyloid plaque Readers: •Private nuclear medicine physicians with no prior training in reading florbetapir-PET scans

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Independent, blinded reader trainees<br>Seven practicing nuclear medicine physicians with no prior training in reading scans from florbetapir-PET, or other amyloid imaging agents. | Drug: florbetapir F 18<br>* IV injection, 370MBq (10mCi), single dose (intervention for Study A05 participants, source of scans for this study)<br>* Other names: florbetapir;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-reader Agreement - Median Kappa Statistic | 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. | 50-60 min after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Inter-reader Agreement - Fleiss' Kappa | Seven readers blinded to all clinical information using the binary read methodology (amyloid positive/negative). Fleiss' kappa was calculated across all inter-reader comparisons. | 50-60 min after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyloid imaging, Positron Emission Tomography, 18F-AV-45, florbetapir F 18, Diagnostic imaging