Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
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|ClinicalTrials.gov Identifier: NCT01265394|
Recruitment Status : Completed
First Posted : December 23, 2010
Results First Posted : June 21, 2013
Last Update Posted : July 2, 2013
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|Condition or disease||Intervention/treatment||Phase|
|Healthy||Drug: [18F] Flutemetamol||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||218 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Experimental: (18F) Flutemetamol||
Drug: [18F] Flutemetamol
Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Other Name: AH110690
- 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).
- 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.
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|Ages Eligible for Study:||18 Years to 40 Years (Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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.
- 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.
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
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Paul Sherwin, MD, PhD||GE Healthcare|
|Responsible Party:||GE Healthcare|
|Other Study ID Numbers:||
|First Posted:||December 23, 2010 Key Record Dates|
|Results First Posted:||June 21, 2013|
|Last Update Posted:||July 2, 2013|
|Last Verified:||June 2013|
Magnetic resonance imaging
Positron Emission Tomography
Standard uptake value ratios
Molecular Mechanisms of Pharmacological Action