Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

Phase 3

Completed

• Conditions: Brain Fibrillarab Levels
• Interventions: Drug: [18F] Flutemetamol

• Registration Number: NCT01165554
• Lead Sponsor: GE Healthcare

Brief Summary

To determine the level of association between quantitative regional estimates of brain uptake of \[18F\]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-21
• Study First Submitted QC: 2010-07-19
• Study First Posted: 2010-07-20
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2013-05-07
• Status Verified: 2013-11
• Results First Submitted QC: 2013-11-08
• Last Update Submitted: 2013-11-08
• Results First Posted: 2013-12-04
• Last Update Posted: 2013-12-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 203

Inclusion Criteria

• The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator.
• The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia.
• The subject's general health is adequate to undergo the study procedures.

Exclusion Criteria

• The subject has a contraindication for PET.
• The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
• The subject is unable to tolerate or cooperate with study procedures.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F] Flutemetamol	[18F] Flutemetamol	-

Primary Outcome Measures

Name	Time	Method
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.	Post flutemetamol administration.	A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants).; Blinded visual interpretations of \[18F\]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.

Secondary Outcome Measures

Name	Time	Method
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference.	Post flutemetamol administration.	Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images.	Post Flutemetamol administrations	A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader "N") divided by the (Total number of normal participants).; Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images.
Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference.	Post flutemetamol administration.	Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States