Phase 3
N=203
Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels
Brain Fibrillarab Levels
Bottom Line
View on ClinicalTrials.gov: NCT01165554 ↗Enrolled (actual)
203
Serious AEs
2.2%
Results posted
Dec 2013
Primary outcome: Primary: The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. — 81; 88; 93; 93 Percentage of Sensitivity by Reader
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- [18F] Flutemetamol (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Nov 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. |
81; 88; 93; 93; 88 | — |
| SECONDARY Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images. |
88; 92; 44; 80; 92 | — |
| SECONDARY Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference. |
91; 95; 98; 91; 91 | — |
| SECONDARY Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference. |
92; 88; 56; 88; 92 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT01165554). 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.