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Completed

NCT Number: NCT02090855

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

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.

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Key information

Conditions

Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

55 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

GE Healthcare

Princeton, New Jersey, 08540, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. The Number of Abnormal Blinded Visual PET Image Interpretations.

    Time frame: Brain images will be assessed up to 1 year post subject's death.

    Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.

  2. Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans

    Time frame: Brain images will be assessed up to 1 year post subject's death.

    Blinded visual assessment of each subject's Flutemetamol (18F) Injection brain PET images as positive or negative will be performed by 5 independent blinded readers trained in the interpretation of [18F]flutemetamol PET images through an electronic training program.

Secondary outcomes

  1. Number of Blinded Visual PET Image Interpretations

    Time frame: Brain images will be assessed up to 1 year post subject's death.

    Specificity of blinded visual image interpretations according to neuropathological criteria.

  2. Specificity Percentage of Blinded Visual PET Image Interpretations

    Time frame: Brain images will be assessed up to 1 year post subject's death.

    Specificity of blinded visual image interpretations according to neuropathological criteria, which is defined as the neuritic plaque density, neurofibriilary tangles and vasculpoathy in the brain.

Sponsors and collaborators

Lead sponsor

GE Healthcare

Industry

Collaborators

  • Covance
  • H2O Clinical LLC

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Mar 18, 2014
Registry last updated
Mar 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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