Clinical Trial: Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
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 Adul
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.
Detailed Summary:
Sponsor: GE Healthcare
Current Primary Outcome: 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).
Original Primary Outcome: Percent of brain scans not showing amyloid [ Time Frame: The duration of subject involvement after imaging will be about 24 hours. ]
Current Secondary Outcome: 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.
Original Secondary Outcome: Amyloid content in different parts of the Brain [ Time Frame: The duration of subject involvement after imaging will be about 24 hours. ]
Information By: GE Healthcare
Dates:
Date Received: December 21, 2010
Date Started: December 2010
Date Completion:
Last Updated: June 21, 2013
Last Verified: June 2013
