Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects

Study Overview
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Brief Summary
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Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.

Official Title
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A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40

Conditions
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Healthy

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 age is 18 to 40 years. The subject has no evidence of thinking or memory problems by medical history. The subject has a normal MRI scan. The subject's general health is adequate to comply with study procedures. The subject is willing and able to participate in all study procedures. Exclusion Criteria: The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT). The subject has a contraindication for (cannot undergo) MRI. The subject has a history of head injury with loss of consciousness. The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology. The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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
Allocation: Non-Randomized
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, 185 MBq/5 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 |
| --- | --- | --- |
| Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid | The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging. The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading). | PET scans performed on patients 90 minutes post Flutemetmol Administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of Amyloid Content in Different Parts of the Brain | Is the computerized measurement of amyloid content in different parts of the brain. The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection. The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements. | PET scans performed on patients 90 minutes post Flutemetmol Administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyloid, Magnetic resonance imaging, Positron Emission Tomography, Standard uptake value ratios, Healthy Subjects