Phase 3
N=276
Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images
Alzheimer's Disease · Mild Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01672827 ↗Enrolled (actual)
276
Serious AEs
—
Results posted
Dec 2013
Primary outcome: Primary: Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. — 94; 92; 90; 94 Percentage (True Positive)
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- [18F]Flutemetamol (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- GE Healthcare
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. |
94; 92; 90; 94; 84; 94 | — |
| PRIMARY Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. |
79; 81; 93; 77; 96; 92 | — |
| SECONDARY Inter-Reader Agreement of PET Images Without Anatomic Images |
248; 257; 242; 251; 255; 250 | — |
Summary
To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.
Eligibility Criteria
Inclusion Criteria
- Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq.
- The subject was classified as one of the following:
- End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status.
- Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status.
- Elderly healthy volunteer (age ≥55).
- Young healthy volunteer (age ≤40).
- Subject with probable Alzheimer Disease (pAD).
- Subject with amnestic Mild Cognitive Impairment (aMCI).
Exclusion Criteria
- Not Applicable
Data sourced from ClinicalTrials.gov (NCT01672827). 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.