Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images

Study Overview
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Brief Summary
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To Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]flutemetamol Positron Emission Tomography (PET) Images.

Official Title
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A Study to Evaluate the Effectiveness of an Electronic Training Program for Orienting and Interpreting [18F]Flutemetamol Positron Emission Tomography (PET) Images.

Conditions
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Alzheimer's Disease, Mild Cognitive Impairment

Intervention / Treatment
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* Drug: [18F]Flutemetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject received a dose of Flutemetamol F 18 Injection ranging from approximately 185 MBq to approximately 370 MBq. The subject was classified as one of the following: End-of-life subject who expired and underwent brain autopsy, with histochemical (HC) confirmation of brain amyloid status. Subject with known/suspected normal pressure hydrocephalus (NPH) who underwent brain biopsy, with HC confirmation of brain amyloid status. Elderly healthy volunteer (age ≥55). Young healthy volunteer (age ≤40). Subject with probable Alzheimer Disease (pAD). Subject with amnestic Mild Cognitive Impairment (aMCI). Exclusion Criteria: Not Applicable

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F]Flutemetamol<br> | Drug: [18F]Flutemetamol<br>* No drug is administered in this intervention. These are scanned images being reviewed, previously acquired in various GE-067 studies.<br>* Other names: Flutemetamol;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Sensitivity of the Blinded Visual PET Image Interpretations Without Anatomic Images. | Statistical analysis of summary of the blinded visual PET Image Interpretations without Anatomic Images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study. These Readers examined the PET images for evidence of amyloid plaque. | Post flutemetamol administration | 
| Summary of Specificity of Blinded Visual PET Image Interpretations Without Anatomic Images. | Statistical analysis of summary of sensitivity of blinded visual PET image interpretations without anatomic images. This data consists of image interpretations by 5 Readers and No subjects were dosed in this study.These Readers examined the PET images for evidence of amyloid plaque. | Post flutemetamol administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inter-Reader Agreement of PET Images Without Anatomic Images | Statistical analysis of Inter-Reader Agreement of PET Images without anatomic Images. This data consists of image interpretations by investigators and No subjects were dosed in this study. | Post Flutemetamol Injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Alzheimer's Disease, Mild Cognitive Impairment, Positron Emission Tomography (PET), PET Images