Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem

Study Overview
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Brief Summary
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Data from subjects who had previously been dosed with Flutemetamol (18F) Injection and imaged in Study GE-067-007, and who died on or before 10 June 2013, will be analyzed. The PET brain images previously obtained in Study GE-067-007 will be interpreted visually in randomized by 5 independent readers who are blinded to all other subject information, and the images will be classified as abnormal (positive for abnormal neuritic plaque density) or normal (negative for abnormal neuritic plaque density). The numbers of images in each category will be used to calculate sensitivity and specificity.

Official Title
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A Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Postmortem.

Conditions
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Cognitive Impairment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject was enrolled in prior Study GE067-007. The subject died on or before 10 June 2013. The subject's brain is judged to be of suitable quality for analysis, including all regions necessary for analysis. Exclusion Criteria: Not Applicable

Ages Eligible for Study
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Minimum Age: 55 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Flutemetamol (18F)<br>There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Abnormal Blinded Visual PET Image Interpretations. | Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program. | Brain images will be assessed up to 1 year post subject's death. | 
| Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans | Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program. | Brain images will be assessed up to 1 year post subject's death. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Blinded Visual PET Image Interpretations | Specificity of blinded visual image interpretations according to neuropathological criteria. | Brain images will be assessed up to 1 year post subject's death. | 
| Specificity Percentage of Blinded Visual PET Image Interpretations | Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain. | Brain images will be assessed up to 1 year post subject's death. |