Overview

This trial is active, not recruiting.

Condition cognitive impairment.
Phase phase 3
Sponsor GE Healthcare
Collaborator Covance Laboratories Ltd.
Start date September 2013
End date May 2014
Trial size 107 participants
Trial identifier NCT02090855, GE-067-026

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective retrospective
Arm
There are no interventions in this study. This study is to assess the images taken previously from another study, GE-067-007.

Primary Outcomes

Measure
Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images
time frame: Brain images will be assessed up to 1 year post subject's death.

Secondary Outcomes

Measure
Sensitivity and specificity according to the recently published criteria
time frame: Brain images will be assessed up to 1 year post subject's death.

Eligibility Criteria

Male or female participants at least 55 years old.

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

Additional Information

Official title A Re-Read Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Neuritic Plaque Density Determined Post-mortem
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by GE Healthcare.