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

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

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 Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [18F] Flutemetamol

• Study Type: Interventional
• Enrollment (Actual): 218
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Princeton, New Jersey, United States, 08540
      • GE Healthcare

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: (18F) Flutemetamol	Drug: [18F] Flutemetamol; Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.; Other Names: AH110690

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid	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).	PET scans performed on patients 90 minutes post Flutemetmol Administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Measurement of Amyloid Content in Different Parts of the Brain	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.	PET scans performed on patients 90 minutes post Flutemetmol Administration

Collaborators and Investigators

• Sponsor: GE Healthcare
• Collaborators: Medpace, Inc.; i3 Statprobe
• Investigators: Study Director: Paul Sherwin, MD, PhD, GE Healthcare

Study record dates

Study Major Dates

• Study Start: December 1, 2010
• Primary Completion (Actual): March 1, 2011
• Study Completion (Actual): April 1, 2011

Study Registration Dates

• First Submitted: December 21, 2010
• First Submitted That Met QC Criteria: December 21, 2010
• First Posted (Estimate): December 23, 2010

Study Record Updates

• Last Update Posted (Estimate): July 2, 2013
• Last Update Submitted That Met QC Criteria: June 21, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Positron Emission Tomography; Healthy Subjects; Amyloid; Standard uptake value ratios
• Additional Relevant MeSH Terms: Metabolic Diseases; Proteostasis Deficiencies; Amyloidosis; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Flutemetamol
• Other Study ID Numbers: GE-067-015