Phase 4
N=96
The Feasibility of Florbetapir Quantitation
Alzheimers Disease
Bottom Line
View on ClinicalTrials.gov: NCT01946243 ↗Enrolled (actual)
96
Serious AEs
—
Results posted
Jun 2015
Primary outcome: Primary: Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers) — 81.7; 88.8; 7.1 Percent Accuracy — p=0.0029
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Florbetapir F18 (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Avid Radiopharmaceuticals
- Primary completion
- Apr 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Total Accuracy (MIMNeuro Software, Low Accuracy Readers) |
81.7; 88.8; 7.1 | 0.0029 sig |
| PRIMARY Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm Low Accuracy Readers) |
87.0; 91.8; 4.9 | 0.0025 sig |
| SECONDARY Change in Total Accuracy (MIMNeuro Software, All Readers) |
89.5; 93.8; 4.2 | — |
| SECONDARY Change in Reliability (MIMNeuro Software) |
0.72; 0.79; 0.06; 0.73; 0.81; 0.08 | — |
| SECONDARY Change in Total Accuracy (Siemens Syngo.PET Software, Experimental Arm All Readers) |
91.6; 93.9; 2.3 | — |
| SECONDARY Change in Reliability (Siemens Syngo.PET Software) |
0.75; 0.82; 0.07; 0.76; 0.80; 0.04 | 0.0280 sig |
Summary
The overall objective of the study is to assess the feasibility of implementing a quantitative process of florbetapir F 18 scan interpretation. The hypothesis is that the use of quantitative analysis will increase the accuracy of florbetapir F 18 scan interpretation.
Eligibility Criteria
Inclusion Criteria
- Readers have undergone Amyvid reader training
- Readers have minimal experience with quantitation of amyloid PET scans
Exclusion Criteria
- Readers have previously been trained to quantitate amyloid PET scans
Data sourced from ClinicalTrials.gov (NCT01946243). 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.