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

Primary Purpose

Healthy

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
[18F] Flutemetamol
Sponsored by
GE Healthcare
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Healthy focused on measuring Amyloid, Magnetic resonance imaging, Positron Emission Tomography, Standard uptake value ratios, Healthy Subjects

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • GE Healthcare

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

(18F) Flutemetamol

Arm Description

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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.

Full Information

First Posted
December 21, 2010
Last Updated
June 21, 2013
Sponsor
GE Healthcare
Collaborators
i3 Statprobe, Medpace, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01265394
Brief Title
Positron Emission Tomography (PET) Amyloid Imaging of the Brain in Healthy Young Adult Subjects
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GE Healthcare
Collaborators
i3 Statprobe, Medpace, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy
Keywords
Amyloid, Magnetic resonance imaging, Positron Emission Tomography, Standard uptake value ratios, Healthy Subjects

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
218 (Actual)

8. Arms, Groups, and Interventions

Arm Title
(18F) Flutemetamol
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
[18F] Flutemetamol
Other Intervention Name(s)
AH110690
Intervention Description
Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Primary Outcome Measure Information:
Title
Number of Brain Scans in Healthy Young Adults Subjects Which do Not Show Amyloid
Description
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).
Time Frame
PET scans performed on patients 90 minutes post Flutemetmol Administration
Secondary Outcome Measure Information:
Title
Measurement of Amyloid Content in Different Parts of the Brain
Description
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.
Time Frame
PET scans performed on patients 90 minutes post Flutemetmol Administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul Sherwin, MD, PhD
Organizational Affiliation
GE Healthcare
Official's Role
Study Director
Facility Information:
Facility Name
GE Healthcare
City
Princeton
State/Province
New Jersey
ZIP/Postal Code
08540
Country
United States

12. IPD Sharing Statement

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

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