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

NCT02090855 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 108

Last updated 2017-03-27

Study results available
· View outcomes & findings →

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

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY
  • H2O Clinical LLC

    collaborator INDUSTRY
  • GE Healthcare

    lead INDUSTRY

Principal Investigators

  • Paul Sherwin, M.D. · GE Healthcare

Eligibility

Min Age
55 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2014-02-28
Completion
2014-02-28

Countries

  • United States

Study Locations

More Related Trials

Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02090855 on ClinicalTrials.gov