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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01265394
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : June 21, 2013
Last Update Posted : July 2, 2013
Sponsor:
Collaborators:
i3 Statprobe
Medpace, Inc.
Information provided by (Responsible Party):
GE Healthcare

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Healthy Drug: [18F] Flutemetamol Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Single-arm, Open-label, Multi-center Study to Determine the Specificity of Flutemetamol (18F) Injection for Excluding the Presence of Brain Amyloid in Healthy Young Adult Subjects Aged 18 to 40
Study Start Date : December 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amyloidosis

Arms and Interventions
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Arm Intervention/treatment
Experimental: (18F) Flutemetamol Drug: [18F] Flutemetamol
Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Other Name: AH110690


Outcome Measures
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Primary Outcome Measures :
  1. Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid [ Time Frame: PET scans performed on patients 90 minutes post Flutemetmol Administration ]

    The visual assessment of Flutemetamol PET image was performed by independent readers trained in the evaluation of PET brain amyloid imaging.

    The measure would consisted of the number of brain scans with amyloid (abnormal reading) or without amyloid (normal reading).



Secondary Outcome Measures :
  1. Measurement of Amyloid Content in Different Parts of the Brain [ Time Frame: PET scans performed on patients 90 minutes post Flutemetmol Administration ]

    Is the computerized measurement of amyloid content in different parts of the brain.

    The Standard Uptake Value Ratio (SUVR) is defined as an average of frontal, anterior cingulate, pariteal, lateral-temporal and posterior cingulate / precuneous uptake following administration of Flutemetamol F18 Injection.

    The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions.

    The Standard Uptake Value Ratio is calculated for two regions of the brain, the Cerebullum and the Pons regions. Both regions of the brain will provide the SUVR measurements.



Eligibility Criteria
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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01265394


Locations
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United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Medpace, Inc.
Investigators
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Study Director: Paul Sherwin, MD, PhD GE Healthcare
More Information
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01265394    
Other Study ID Numbers: GE-067-015
First Posted: December 23, 2010    Key Record Dates
Results First Posted: June 21, 2013
Last Update Posted: July 2, 2013
Last Verified: June 2013
Keywords provided by GE Healthcare:
Amyloid
Magnetic resonance imaging
Positron Emission Tomography
Standard uptake value ratios
Healthy Subjects
Additional relevant MeSH terms:
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Amyloidosis
Proteostasis Deficiencies
Metabolic Diseases
 Flutemetamol
Radiopharmaceuticals
Molecular Mechanisms of Pharmacological Action