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

This study has been completed.
Sponsor:
Collaborators:
i3 Statprobe
Medpace, Inc.
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01265394
First received: December 21, 2010
Last updated: June 21, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Healthy
Drug: [18F] Flutemetamol
Phase 3

Study Type: Interventional
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

Further study details as provided by GE Healthcare:

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.



Enrollment: 218
Study Start Date: December 2010
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: (18F) Flutemetamol Drug: [18F] Flutemetamol
Flutemetamol (18F) Injection, 185 MBq/5 mCi, single intravenous injection.
Other Name: AH110690

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01265394

Locations
United States, New Jersey
GE Healthcare
Princeton, New Jersey, United States, 08540
Sponsors and Collaborators
GE Healthcare
i3 Statprobe
Medpace, Inc.
Investigators
Study Director: Paul Sherwin, MD, PhD GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01265394     History of Changes
Other Study ID Numbers: GE-067-015
Study First Received: December 21, 2010
Results First Received: March 27, 2013
Last Updated: June 21, 2013
Health Authority: 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:
Amyloid
Magnetic resonance imaging
Positron Emission Tomography
Standard uptake value ratios
Healthy Subjects

ClinicalTrials.gov processed this record on August 26, 2014