N/A Completed N=108

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

Mild Cognitive Impairment

Source: ClinicalTrials.gov NCT02090855 ↗

Enrolled (actual)

108

Serious AEs

—

Results posted

Aug 2014

Primary outcomePrimary: The Number of Abnormal Blinded Visual PET Image Interpretations. — 73; 68; 67; 67 Number of Blinded Image Interpretations

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY The Number of Abnormal Blinded Visual PET Image Interpretations.	73; 68; 67; 67; 72; 69	—
PRIMARY Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans	96.1; 89.5; 88.2; 88.2; 94.7; 90.8	—
SECONDARY Number of Blinded Visual PET Image Interpretations	25; 27; 28; 25; 26; 27	—
SECONDARY Specificity Percentage of Blinded Visual PET Image Interpretations	83.3; 90.0; 93.3; 83.3; 86.7; 90.0	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02090855). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.