Post-Authorisation Survey of Nuclear Medicine Physicians and Radiologists in Europe to Evaluate Trends and Patterns in VIZAMYL™ Use in Everyday Clinical Practice in the EU

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation

  Safety study (incl. comparative)
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Retrospective post-authorisation study

Study drug and medical condition

• Medical condition to be studied:
  Dementia Alzheimer's type

Population studied

• Short description of the study population:
  A survey of physicians practicing nuclear medicine or radiologist in at least one of the target countries, had reviewed at least three VIZAMYL™ scans.
• Age groups:
  • Adults (18 to < 46 years)
  • Adults (46 to < 65 years)
  • Adults (65 to < 75 years)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with Alzheimer’s disease
• Estimated number of subjects:
  0

Study design details

• Main study objective:
  To retrospectively determine post-authorisation use of VIZAMYL in everyday clinical practice in the EU.
• Outcomes:
  Summary across survey respondents of reported percentage of patients referred for a VIZAMYL scan for the indication listed in the SmPC. This will be determined separately for each survey round (3 rounds, conducted at 12-month intervals). To retrospectively describe use in everyday clin. practice with regard to: Indication, admin. dose of radioactivity, body region imaged, time from dosing to scan initiation, duration of scanning, type of other images used to assist in interpret. of images, percent. of patients with a contraind who were scanned and not scanned, percent. of readers who have compl training in interpret of PET images
• Data analysis plan:
  Tabulations of summary statistics, graphical presentations, and statistical analyses will be performed using SAS software, Version 9.3 or higher. Descriptive statistics for continuous data in summary tables will include the number of subjects in the analysis (n), mean, standard deviation, median, and range (minimum, maximum). Descriptive statistics for categorical data in summary tables will include counts and percentages. All data entered into the database will be provided in separate data listings showing individual subject values. The planning and reporting of statistical analysis will be carried out as described in the Sponsor and CRO’s standard operating procedures governing clinical studies. Details of the analysis will be provided in the Statistical Analysis Plan. Missing values will not be substituted by estimated values, but treated as missing in the statistical evaluation. All data from all subjects enrolled and imaged in the study will be included in all listings.