Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

218 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2011-04-30

Brief Summary

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Amyloid is an abnormal chemical found in the brain of patients with Alzheimer's Disease (AD). The study drug helps produce pictures of amyloid in the brain. The purpose of this study is to determine how well the study drug performs in young healthy subjects.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NON_RANDOMIZED

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, 185 MBq/5 mCi, single intravenous injection.

Interventions

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[18F] Flutemetamol

Flutemetamol (18F) Injection, 185 MBq/5 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 age is 18 to 40 years.
* The subject has no evidence of thinking or memory problems by medical history.
* The subject has a normal MRI scan.
* The subject's general health is adequate to comply with study procedures.
* The subject is willing and able to participate in all study procedures.

Exclusion Criteria

* The subject has received any medical ionizing radiation exposure in the last 12 months (except planar x-ray or head CT).
* The subject has a contraindication for (cannot undergo) MRI.
* The subject has a history of head injury with loss of consciousness.
* The subject has any significant medical, psychiatric or neurological condition that might be associated with brain pathology.
* The subject has a family history of Alzheimer's Disease (AD); more than 1 first-degree relative.

Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes