Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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|
- 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.
|Study Start Date:||December 2010|
|Study Completion Date:||April 2011|
|Primary Completion Date:||March 2011 (Final data collection date for primary outcome measure)|
|Experimental: (18F) Flutemetamol||
Drug: [18F] Flutemetamol
Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Other Name: AH110690
|United States, New Jersey|
|Princeton, New Jersey, United States, 08540|
|Study Director:||Paul Sherwin, MD, PhD||GE Healthcare|