Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2011-04-30

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.

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Detailed Description

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Conditions

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Normal Pressure Hydrocephalus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Arm 1

Group Type EXPERIMENTAL

[18F]Flutemetamol

Intervention Type DRUG

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.

Interventions

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[18F]Flutemetamol

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.

Intervention Type DRUG

Other Intervention Names

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Flutemetamol AH110690

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.

Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No