European Drug Usage Survey for Amyvid (I6E-MC-AVBF)

Study type

• Study topic:
  Disease /health condition

  Human medicinal product
• Study type:
  Non-interventional study
• Scope of the study:
  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

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

• Short description of the study population:
  Healthcare providers who were referrers for Amyvid PET scans with following criteria:; • physicians in active clinical practice; • hospital- or office-based,; • who practice in an EU country
• 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)
• Special population of interest:
  Other
• Special population of interest, other:
  Patients with Dementia Alzheimer's type
• Estimated number of subjects:
  100

Study design details

• Main study objective:
  To assess the usage patterns of Amyvid in European clinical practice,To assess the level of off-label use in European clinical practice.
• Data analysis plan:
  Reasons for the Amyvid referral will be summarized using responses to the survey questions. The level of off-label use will be reported for each relevant question as a proportion of the total responses and as the total number of questions consistent with off-label use. Results will also be analysed by temporal period (1, 2, or 3 years elapsed since commercial launch of Amyvid) to evaluate if there are trends in patterns of Amyvid use. Reasons for non-response will be evaluated to assess the potential existence of selection bias. Additional information is available in the report.