Positron Emission Tomography (PET) Imaging of Brain Amyloid Compared to Post-Mortem Levels

This study has been completed.
Sponsor:
Collaborators:
i3 Statprobe
Covance
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT01165554
First received: June 21, 2010
Last updated: November 8, 2013
Last verified: November 2013
  Purpose

To determine the level of association between quantitative regional estimates of brain uptake of [18F]flutemetamol and quantitative immunohistochemical regional estimates of brain levels of amyloid estimated from post-mortem analysis of corresponding brain tissue samples.


Condition Intervention Phase
Brain Fibrillarab Levels
Drug: [18F] Flutemetamol
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Principal Open-Label Study to Compare the Brain Uptake of [18F]Flutemetamol With Brain Amyloid Levels Determined Post-Mortem

Further study details as provided by GE Healthcare:

Primary Outcome Measures:
  • The Sensitivity of Blinded Visual Interpretations of [18F]Flutemetamol Positron Emission Tomography (PET) Images Without Anatomic Brain Images for Detecting Brain Fibrillar Amyloid β. [ Time Frame: Post flutemetamol administration. ] [ Designated as safety issue: No ]

    A calculation used to assess Sensitivity was (Number of Blinded Reads determined abnormal by Reader "N") divided by the (Total number of abnormal participants).

    Blinded visual interpretations of [18F]flutemetamol Positron Emission Tomography (PET) images without anatomic brain images for detecting brain fibrillar amyloid β.



Secondary Outcome Measures:
  • Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, Without Anatomic Brain Images. [ Time Frame: Post Flutemetamol administrations ] [ Designated as safety issue: No ]

    A calculation used to assess Specificity was (Number of Blinded Reads determined normal by Reader "N") divided by the (Total number of normal participants).

    Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, without anatomic brain images.


  • Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Abnormal, With Anatomic CT Brain Images for Reference. [ Time Frame: Post flutemetamol administration. ] [ Designated as safety issue: No ]
    Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as abnormal, with anatomic CT brain images for reference.

  • Blinded Visual Interpretation of Each Subject's Flutemetamol F 18 Injection Brain PET Images as Normal, With Anatomic CT Brain Images for Reference. [ Time Frame: Post flutemetamol administration. ] [ Designated as safety issue: No ]
    Blinded visual interpretation of each subject's Flutemetamol F 18 Injection brain PET images as normal, with anatomic CT brain images for reference.


Enrollment: 203
Study Start Date: May 2010
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: [18F] Flutemetamol Drug: [18F] Flutemetamol
Flutemetamol (18F) Injection, 111 to 370 MBq (3 to 10 mCi), single intravenous injection.
Other Name: AH110690

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject has a short life expectancy (approximately 1 year or less) as estimated by the Investigator.
  • The subject is 70 years of age or older if cognitively normal, or 55 years of age or older if terminal because of dementia.
  • The subject's general health is adequate to undergo the study procedures.

Exclusion Criteria:

  • The subject has a contraindication for PET.
  • The subject has a known or suspected hypersensitivity/allergy to [18F]flutemetamol or to any of the excipients.
  • The subject is unable to tolerate or cooperate with study procedures.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01165554

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

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT01165554     History of Changes
Other Study ID Numbers: GE-067-007
Study First Received: June 21, 2010
Results First Received: May 7, 2013
Last Updated: November 8, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GE Healthcare:
Amyloid
PET-Positron Emission Tomography
SUVR-Standard uptake value ratios

ClinicalTrials.gov processed this record on April 17, 2014