Alzheimer's Disease
Conditions
Brief summary
This study is designed to evaluate the agreement between florbetapir F 18 scan interpretation in the clinic and by expert readers.
Interventions
DRUGflorbetapir F 18
No study drug will be administered in this study - scans previously acquired in the course of clinical practice.
Sponsors
Avid Radiopharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
\- Scan obtained for clinical reasons
Exclusion criteria
\- None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Agreement Between Expert Panel and Clinical Practice Reads | Scan acquired 50-60 minutes post injection | Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinical Practice Scans 241 florbetapir F 18 scans and final scan reports interpreted in a clinical setting were collected from physicians across the country. These results were then compared to expert panel interpretations for the same scans.
florbetapir F 18: No study drug was administered in this study - scans previously acquired in the course of clinical practice. | 241 |
| Total | 241 |
Baseline characteristics
| Characteristic | Clinical Practice Scans |
|---|---|
| Age, Customized Age Unknown | 241 scans |
| Region of Enrollment United States | 241 scans |
| Sex/Gender, Customized Gender Unknown | 241 scans |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
Primary
Agreement Between Expert Panel and Clinical Practice Reads
Agreement between expert panel consensus scan interpretations and clinical practice reader scan interpretations was calculated as a weighted Kappa value across all cases and all clinical practice readers.
Time frame: Scan acquired 50-60 minutes post injection
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinical Practice Scans | Agreement Between Expert Panel and Clinical Practice Reads | 0.745 Weighted Kappa statistic |