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
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: 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 October 30, 2014