A Principal Open-Label Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Amyloid Levels Determined Post-Mortem
Overview
- Phase
- Phase 3
- Intervention
- [18F] Flutemetamol
- Conditions
- Brain Fibrillarab Levels
- Sponsor
- GE Healthcare
- Enrollment
- 203
- Locations
- 1
- Primary Endpoint
- The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Eligibility Criteria
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.
Arms & Interventions
[18F] Flutemetamol
Intervention: [18F] Flutemetamol
Outcomes
Primary Outcomes
The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β.
Time Frame: 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 Outcomes
- 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 Normal, Without Anatomic Brain Images.(Post Flutemetamol administrations)
- 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.)