PET Imaging of Brain Amyloid in Normal Pressure Hydrocephalus

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-12-31

Study Completion Date

2010-08-31

Brief Summary

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This study will determine 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 previously obtained during shunt placement in patients who have normal pressure hydrocephalus (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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1 flutemetamol

Group Type EXPERIMENTAL

[18F] Flutemetamol

Intervention Type DRUG

All subjects will receive an intravenous (IV) dose of \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels (MBq).

Interventions

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[18F] Flutemetamol

All subjects will receive an intravenous (IV) dose of \[18F\]flutemetamol (less than 10µg flutemetamol). The nominal activity of a single administration of \[18F\]flutemetamol will be 185 megabecquerels (MBq).

Intervention Type DRUG

Other Intervention Names

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Flutemetamol AH110690

Eligibility Criteria

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Inclusion Criteria

* The subject is 50 years old or older.
* The subject has had a frontal lobe cortical biopsy adequate for the detection and quantitation of amyloid.
* Informed consent has been signed and dated by the subject/and/or subjects' legally acceptable representative, if applicable, in accordance with local regulations.

Exclusion Criteria

* The subject has a contraindication for MRI or PET.
* The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol.
* 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