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

Completed

Conditions studied: Cognitive Impairment

In brief

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.

Key facts

Study ID

NCT02090855

Run by

GE Healthcare

People needed

108

Starts

2013-09-01

Expected to finish

2014-02-01

Last updated by the study team

2017-03-27

Who can join

Age: 55 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Not Applicable

Where it is running

• GE Healthcare — Princeton, New Jersey, United States

Full record on ClinicalTrials.gov

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