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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-02-28

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.

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Detailed Description

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Conditions

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Cognitive Impairment

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Flutemetamol (18F)

There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007.

No interventions assigned to this group

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.