Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Study Overview
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Brief Summary
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To determine the level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical and histochemistry estimates of amyloid levels in frontal lobe biopsy samples obtained from subjects during shunt placement for NPH.

Official Title
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A Principal, Prospective, Open-label Biopsy Study to Validate Detection of Cerebral Cortical Amyloid With Flutemetamol (18F) Injection in Normal Pressure Hydrocephalus (NPH) Subjects.

Conditions
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Normal Pressure Hydrocephalus

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 is at least 50 years of age. The subjects' general health is adequate to comply with study procedures. The subject has been scheduled for a shunt placement procedure for the treatment of NPH. Exclusion Criteria: The subject has a contraindication for MRI or PET. The subject is pregnant or lactating. The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients. The subject has participated in any clinical study using an investigational agent within 30 days of dosing.

Ages Eligible for Study
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Minimum Age: 50 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: Arm 1<br> | Drug: [18F]Flutemetamol<br>* All subjects will receive an IV dose of [18F]flutemetamol (less than 10 mg flutemetamol). The nominal activity of a single administration of [18F]flutemetamol will be 185 MBq.<br>* Other names: AH110690;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Cerebellum (CER) as the Reference Region. | The level of association between the quantitative estimates of brain uptake of [18F]flutemetamol and the quantitative immunohistochemical estimates of amyloid levels in biopsy samples obtained during shunt placement in patients who have Normal Pressure Hydrocephalus (NPH). The quantitative estimates of brain uptake of [18F]flutemetamol (SUVR) will be made from the analysis of PET images. | Post flutemetamol Injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard Uptake Value Ratio (SUVR) at the Site of the Biopsy Based on the Pons as the Reference Region. | The level of association between SUVR and the quantitative estimates (area percents) of amyloid levels for the following regions: Biopsy site and Contralateral and Composite Regions. | Post flutemetamol administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Amyloid, Normal pressure hydrocephalus (NPH), Positron Emission Tomography (PET), Standard uptake value ratios (SUVR)