Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

203 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2011-11-30

Brief Summary

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To determine the level of association between quantitative regional estimates of brain uptake of \[18F\]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.

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Detailed Description

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Conditions

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Brain Fibrillarab Levels

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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[18F] Flutemetamol

Group Type EXPERIMENTAL

[18F] Flutemetamol

Intervention Type DRUG

Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.

Interventions

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[18F] Flutemetamol

Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.

Intervention Type DRUG

Other Intervention Names

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AH110690

Eligibility Criteria

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Inclusion Criteria

* The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator.
* The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia.
* The subject's general health is adequate to undergo the study procedures.

Exclusion Criteria

* The subject has a contraindication for PET.
* The subject has a known or suspected hypersensitivity/allergy to \[18F\]flutemetamol or to any of the excipients.
* The subject is unable to tolerate or cooperate with study procedures.

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No