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

Phase 3

Completed

• Conditions: Healthy
• Interventions: Drug: [18F] Flutemetamol

• Registration Number: NCT01265394
• Lead Sponsor: GE Healthcare

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 Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-21
• Study First Submitted QC: 2010-12-21
• Study First Posted: 2010-12-23
• Primary Completion: 2011-03
• Study Completion: 2011-04
• Results First Submitted: 2013-03-27
• Results First Submitted QC: 2013-05-14
• Status Verified: 2013-06
• Results First Posted: 2013-06-21
• Last Update Submitted: 2013-06-21
• Last Update Posted: 2013-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 218

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
(18F) Flutemetamol	[18F] Flutemetamol	-

Primary Outcome Measures

Name	Time	Method
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid	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

Name	Time	Method
Measurement of Amyloid Content in Different Parts of the Brain	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.

Trial Locations

Locations (1)

GE Healthcare; 🇺🇸 Princeton, New Jersey, United States