A prospective observational study to assess effectiveness of the training and risk minimisation measures recommended for the usage of the diagnostic agent NeuraCeqTM in the post-authorisation clinical situation: A post-authorisation safety study (PASS)

Study type

• Study topic:
  Human medicinal product

  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Assessment of risk minimisation measure implementation or effectiveness

  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Effectiveness evaluation of training material
• Data collection methods:
  Combined primary data collection and secondary use of data

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Prospective observational study to assess effectiveness of the training and risk minimisation measures recommended for the usage of the diagnostic agent NeuraCeqTM in the post-authorisation clinical situation, post-authorisation safety study

Study drug and medical condition

• Anatomical Therapeutic Chemical (ATC) code:
  (V09AX06) florbetaben (18F)

  florbetaben (18F)
• Medical condition to be studied:
  Dementia Alzheimer's type

Population studied

• Short description of the study population:
  Physicians who order Neuraceq for clinical usage after marketing authorisation in Europe.
• 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:
  100

Study design details

• Main study objective:
  1. To monitor effectiveness of nationally approved material to enable PET scan readers to correctly classify abnormal or normal Florbetaben (18F) tracer uptake in the brain.2. To monitor the understanding and compliance of readers with the approved indication, limitation of use and interpretation of Florbetaben (18F) images.
• Data analysis plan:
  Due to the exploratory nature of the study, the analysis will be mostly descriptive. For categorical data, absolute and relative frequencies (in %) will be calculated. Quantitative data will be shown by descriptive statistics (mean, SD, min, max, median, quartiles). 95%-confidence intervals will be computed for frequencies and means as appropriate. For both primary variables the variation among the readers will be addressed by displaying the frequency distribution of readers on the number of reading errors resp. incorrect answers (e.g. number of readers who show reading errors 0-10%, >10-20%, >20-30% etc.).