Pattern of use, safety and tolerability of the diagnostic agent NeuraCeqTM in European clinical practice: A cross-sectional, retrospective, non-interventional post-authorisation safety study (PASS) (FBB-01_03_13)

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

  Drug utilisation
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Cross-sectional

  Other
• Non-interventional study design, other:
  Physicians survey, Post-authorization 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 have referred at least one patient for a clinical NeuraCeqTM PET scan in European countries where the radiopharmaceutical is commercially available
• 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:
  Renal impaired

  Hepatic impaired
• Estimated number of subjects:
  400

Study design details

• Main study objective:
  1.Describe the Usage Pattern of NeuraCeq in routine clinical practice2.Monitor off-label use of in cognitively normal and in persons with Down’s syndrome3.Monitor the safety profile of NeuraCeq in a real life population including:- patients with renal impairment - patients with hepatic impairment- potential effects of drug-drug interactions- occurence of hypersensitivity reactions.
• Data analysis plan:
  No a priori hypothesis has been formulated and the analysis will be purely descriptive. Variables collected during the study will mainly be categorical, such as the reason why patients are receiving imaging, or whether imaging was done in accordance with the SmPC or off-label.The power calculation for this study is based on defining an acceptable width for the confidence intervals for the percentage of patients with off label use. Overall study population will be analysed and reported AEs compared to the Phase III data. Data for patients with renal or hepatic impairment will be analyzed with regards to reported AEs and this will be compared to the overall study population to identify a potential difference. Analysis and comparison of the proportion of patients taking concomitant medications including disulfiram, and those with co-morbidities vs. those patients who are not receiving medication and without co-morbidities, will be conducted.