A Study to Evaluate the Effectiveness of VIZAMYL™ Reader Training Programme in Europe

Study Overview
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Brief Summary
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This is a study to determine the effectiveness of the VIZAMYL™ reader training programme in clinical practice in Europe

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

Conditions
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Cognitive Impairment

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. The VIZAMYL™ scan was ordered as part of the clinical care of the subject and is not exclusively for a clinical trial. If informed consent is required by the local IEC, 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 de-identified demographic information. Exclusion Criteria: If informed consent is required by the local IEC, the subject (or representative) is not willing to consent to their de-identified images and other data being used in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the diagnostic accuracy determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice | Diagnostic accuracy is defined as the (number of true positives + number of true negatives) / total number of evaluable images. The 95% exact binomial confidence interval of the accuracy estimate will also be provided. | Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes. | 
| Determine the diagnostic sensitivity determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice | The sensitivity is defined as the number of true positives / (number of true positives + number of false negatives). The 95% exact binomial confidence interval of the sensitivity will also be provided. | Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes. | 
| Determine the specificity determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice | The specificity is defined as the number of true negatives / (number of true negatives + number of false positives). The 95% exact binomial confidence interval of the specificity will also be provided. | Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes. | 
| Determine the positive predictive value (PPV) determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice | The PPV is defined as the number of true positives / (number of true positives + number of false positives). The 95% exact binomial confidence interval of the specificity will also be provided. | Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes. | 
| Determine the negative predictive value (NPV) determined across all images (at least 200 images), as indicators of the collective proficiency of the clinical readers at interpreting VIZAMYL™ PET images obtained in clinical practice | The NPV is defined as the number of true negatives / (number of true negatives + number of false negatives). The 95% exact binomial confidence interval of the specificity will also be provided. | Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the impact of demographic and other factors (such as method of training, gap between training and reading, and country) on diagnostic accuracy to try to identify factors that may be associated with image interpretation errors | Diagnostic accuracy, estimated as (number of true positives + number of true negatives) / total number of evaluable images, will be provided for different subgroups of demographic and other factors. | Duration of 1 VIZAMYL™ injection and PET scan, approximately 90 minutes. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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flutemetamol, Vizamyl, Alzheimer's disease, cognitive impairment, dementia