Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

Study Overview
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Brief Summary
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To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.

Official Title
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A Principal Open-Label Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Amyloid Levels Determined Post-Mortem

Conditions
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Brain Fibrillarab Levels

Intervention / Treatment
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* Drug: [18F] Flutemetamol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator. The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia. The subject's general health is adequate to undergo the study procedures. Exclusion Criteria: The subject has a contraindication for PET. The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients. The subject is unable to tolerate or cooperate with study procedures.

Ages Eligible for Study
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Minimum Age: 55 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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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: [18F] Flutemetamol<br> | Drug: [18F] Flutemetamol<br>* Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.<br>* Other names: AH110690;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. | A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader N) divided by the (Total number of abnormal participants). Blinded visual interpretations of [18F]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β. | Post flutemetamol administration. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images. | A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader N) divided by the (Total number of normal participants). Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images. | Post Flutemetamol administrations | 
| Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference. | Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference. | Post flutemetamol administration. | 
| Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference. | Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference. | Post flutemetamol administration. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyloid, PET-Positron Emission Tomography, SUVR-Standard uptake value ratios