Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
This study has been completed.
Information provided by (Responsible Party):
First received: December 21, 2010
Last updated: June 21, 2013
Last verified: June 2013
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.
Drug: [18F] Flutemetamol
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
||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
Primary Outcome Measures:
- 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).
Secondary Outcome Measures:
- 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:
| Study Completion Date:
| 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
|Ages Eligible for Study:
||18 Years to 40 Years (Adult)
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01265394
|Princeton, New Jersey, United States, 08540 |
||Paul Sherwin, MD, PhD
History of Changes
|Other Study ID Numbers:
|Study First Received:
||December 21, 2010
|Results First Received:
||March 27, 2013
||June 21, 2013
||United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Finland: Finnish Medicines Agency
Sweden: Medical Products Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Keywords provided by GE Healthcare:
ClinicalTrials.gov processed this record on December 02, 2016
Magnetic resonance imaging
Positron Emission Tomography
Standard uptake value ratios