Study type

Study type

Non-interventional study

Scope of the study

Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cross-sectional
Other

Non-interventional study design, other

Cross-sectional assessment of specialist physicians who read florbetapir PET scans in routine EU medical practice at two points in time after commercial launch.
Study drug and medical condition

Anatomical Therapeutic Chemical (ATC) code

(V09AX05) florbetapir (18F)
florbetapir (18F)

Medical condition to be studied

Dementia Alzheimer's type
Population studied

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

75
Study design details

Main study objective

(1) to assess the frequency of reading errors in routine clinical practice after training implementation, and (2) to assess reader understanding of, and compliance with, the indication with respect to image interpretation after training implementation.

Data analysis plan

No formal a priori hypothesis will be tested in this study. Scan interpretation results from clinical practice readers will be compared to results from an expert consensus panel on the same scan using accuracy, sensitivity, specificity, error rate, false negative rate, false positive rate with corresponding 95% confidence intervals based on the Wilson score method. Reader understanding of the florbetapir indication will be calculated as the proportion of responses correctly identifying example reports as consistent/inconsistent with the EU Summary of Product Characteristics.