A Post-Authorisation Safety Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training in Europe

Study type

• Study topic:
  Disease /health condition
• Study type:
  Non-interventional study
• Scope of the study:
  Safety study (incl. comparative)

  Other
• If ‘other’, further details on the scope of the study:
  Assessment Reading Training Programme
• Data collection methods:
  Primary data collection

Non-interventional study

• Non-interventional study design:
  Other
• Non-interventional study design, other:
  Phase 4, post-authorisation safety study

Study drug and medical condition

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

Population studied

• Short description of the study population:
  The study population included patients aged 18 years or older diagnosed with Alzheimer’s disease (AD) and other causes of cognitive impairment who had been referred by the physician for a clinically indicated VIZAMYL™ PET brain scan in European countries. ; Inclusion criteria:; 1. The subject is an adult (aged 18 years or older) of any race or gender and has been referred for a VIZAMYL™ PET brain scan as part of the assessment of his/her cognitive impairment.; 2. The VIZAMYL™ scan was ordered as part of the clinical care of the subject and is not exclusively for a clinical trial. ; 3. The subject, or his/her legally authorised representative, is willing and able to sign consent for use of their de-identified VIZAMYL™ PET images and associated anatomic images (brain CT and/or MRI) used in the interpretation of the VIZAMYL™ images as well as deidentified demographic information. ; ; Exclusion criteria:; 1. The subject (or representative) is not willing to consent to their de-identified images and other data being used in this study.
• 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 Alzheimer’s disease
• Estimated number of subjects:
  200

Study design details

• Main study objective:
  Assess effectiveness of the VIZAMYL™ reader training programmes (in-person or electronic) in Europe by estimating the diagnostic accuracy, sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of the visual interpretation of VIZAMYL™ images obtained in clinical practice.
• Outcomes:
  Diagnostic accuracy (point estimates and exact 95% CIs) determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images. Diagnostic accuracy will give an indication of the overall image interpretation error rate (1 minus diagnostic accuracy). Sensitivity, specificity, PPV, and NPV.
• Data analysis plan:
  Diagnostic accuracy, sensitivity, specificity, PPV, and NPV value will be determined for each reader, and reported as point estimates with exact 95% confidence intervals (CIs).