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Positron Emission Tomography Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

NCT ID: NCT01092546

Last Updated: 2013-12-13

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.

Detailed Description

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Conditions

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Normal Pressure Hydrocephalus

Keywords

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Amyloid Normal pressure hydrocephalus (NPH) Positron Emission Tomography (PET) Standard uptake value ratios (SUVR)

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

Sponsors

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i3 Statprobe

INDUSTRY

Sponsor Role collaborator

GE Healthcare

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim A Mansfield, MS

Role: STUDY_DIRECTOR

GE Healthcare

Locations

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GE Healthcare

Princeton, New Jersey, United States

Site Status

Countries

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United States

Other Identifiers

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GE-067-009

Identifier Type: -

Identifier Source: org_study_id