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

Cognitive Impairment. Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02090855
• Other study ID #: GE-067-026
• Status: Completed
• Phase: Phase 3
• First received: March 11, 2014
• Last updated: September 11, 2014
• Start date: September 2013
• Est. completion date: February 2014

Study information

• Verified date: September 2014
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationBelgium: Federal Agency for Medicinal Products and Health ProductsFinland: Finnish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: February 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 55 Years and older

Eligibility

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:

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Impairment.

Locations

Country	Name	City	State
United States	GE Healthcare	Princeton	New Jersey

Sponsors (3)

Lead Sponsor	Collaborator
GE Healthcare	Covance, H2O Clinical LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Number of Abnormal Blinded Visual PET Image Interpretations.	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.	Brain images will be assessed up to 1 year post subject's death.	No
Primary	Sensitivity Percentage of Blinded Visual PET Image Interpretations of Subjects With Abnormal Scans	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.	Brain images will be assessed up to 1 year post subject's death.	No
Secondary	Number of Blinded Visual PET Image Interpretations	Specificity of blinded visual image interpretations according to neuropathological criteria.	Brain images will be assessed up to 1 year post subject's death.	No
Secondary	Specificity Percentage of Blinded Visual PET Image Interpretations	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.	Brain images will be assessed up to 1 year post subject's death.	No