NCT02090855

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 108 (actual)
• Sponsor: GE Healthcare · Industry
• Sex: All
• Age: 55 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Cognitive Impairment

Timeline

• Start date: 2013-09-01
• Primary completion: 2014-02-01
• Completion: 2014-02-01
• First posted: 2014-03-18
• Last updated: 2017-03-27
• Results posted: 2014-08-27

Locations

1 site across 1 country: United States