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Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Piramal Imaging SA
ClinicalTrials.gov Identifier:
NCT01020838
First received: November 16, 2009
Last updated: May 9, 2013
Last verified: May 2013
  Purpose

To determine the sensitivity and specificity of the visual assessment of regional tracer uptake in the Florbetaben PET images compared to histological verification of the presence or absence of cerebral β-amyloid in the respective histopathologic post mortem specimens as the standard of truth


Condition Intervention Phase
Alzheimer Disease
Drug: Florbetaben (BAY94-9172)
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: An Open-label, Non-randomized Study to Evaluate the Efficacy and Safety of BAY94-9172 (ZK 6013443) Positron Emission Tomography (PET) Imaging for Detection/Exclusion of Cerebral Beta-amyloid When Compared to Postmortem Histopathology

Resource links provided by NLM:


Further study details as provided by Piramal Imaging SA:

Primary Outcome Measures:
  • Sensitivity and specificity of the visual assessment of tracer uptake compared to histological verification of the presence or absence of cerebral beta-amyloid in postmortem specimens [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sensitivity and specificity of the composite "whole brain" regional visual assessment in detecting/excluding cerebral β-amyloid plaques based on the "whole brain" histopathological verification of the presence/absence of ß-amyloid deposition [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of the quantitative assessment of regional tracer uptake in BAY94-9172 PET images compared to histological verification of presence/absence of cerebral ß-amyloid in the respective postmortem specimens as the standard of truth [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
  • Sensitivity and specificity of the visual assessment of BAY 94-9172 PET images on the subject level (according to the RCTU and BAPL rating scale) in detecting/excluding cerebral β-amyloid compared to the onsite neuropathological diagnosis [ Time Frame: On day 1 - one scanning period after injection ] [ Designated as safety issue: No ]
  • To evaluate the safety and tolerability of a single dose of BAY94-9172 [ Time Frame: 8 days ] [ Designated as safety issue: Yes ]

Enrollment: 216
Study Start Date: November 2009
Estimated Study Completion Date: August 2014
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Florbetaben (BAY94-9172)
Single intravenous injection 1-5ml

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Females, no child-bearing potential or negative urine pregnancy test on day of BAY94-9172 injection
  • Exhibits visual, auditory, and communicative capabilities adequate to provide informed consent or assent and comply with study procedures
  • Is willing and able to lie down in magnetic resonance imaging (MRI) and positron emission tomography (PET) scanners
  • Is willing to donate their brain for postmortem examination in case of death
  • The subject, or the subject and/or legally acceptable representative will be compliant and have a high probability of completing the study in the opinion of the investigator
  • Has been fully informed about the study, including provisions of the Health Insurance Portability and Accountability Act (HIPAA), as applicable, and informed consent or assent has been signed and dated (with time) by the subject and/or the subject's legally acceptable representative
  • The subjects who have participated in a previous florbetaben study e.g. study 311741 may be included in the present study. The MRI- and florbetaben PET scan do not need to be repeated if both scans were performed within twelve months prior to inclusion.

Exclusion Criteria:

  • Has severe cerebral macrovascular (ie, multi-stroke) disease or brain tumor (metastasis/brain cancer) as verified by MRI
  • Has any contraindication to magnetic resonance imaging (MRI) examination, eg, metal implants or phobia as determined by the onsite radiologist performing the scan
  • Has been previously enrolled in this study or participated in a clinical study involving an investigational pharmaceutical product within 30 days prior to screening and/or was administered a radiopharmaceutical within 10 radioactive half-lives prior to study drug administration in this study
  • Has severe cardio-vascular instability requiring intensive care surveillance and/or therapeutic intervention (i.e. catecholamine infusion)
  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: NCT01020838

Locations
United States, Arizona
Sun City, Arizona, United States, 85351
United States, California
Stanford, California, United States, 94305
United States, Florida
Tampa, Florida, United States, 33616
United States, New Jersey
Teaneck, New Jersey, United States, 07666
United States, Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Texas
Dallas, Texas, United States, 75390
Houston, Texas, United States, 77030
San Antonio, Texas, United States, 78229
Australia, Victoria
Heidelberg, Victoria, Australia, 3084
France
Lille, France, 59037
Strasbourg, France, 67091
Germany
Jülich, Nordrhein-Westfalen, Germany, 52425
Leipzig, Sachsen, Germany, 04103
Japan
Toyohashi, Aichi, Japan, 441-8021
Toyohashi, Aichi, Japan, 440-0045
Toyohashi, Aichi, Japan, 441-8124
Isezaki, Gunma, Japan, 372-0006
Hamamatsu, Shizuoka, Japan, 432-8580
Itabashi-ku, Tokyo, Japan, 173-0015
Sponsors and Collaborators
Piramal Imaging SA
Investigators
Study Director: Piramal Imaging SA Study Director Piramal Imaging SA
  More Information

Additional Information:
No publications provided

Responsible Party: Piramal Imaging SA
ClinicalTrials.gov Identifier: NCT01020838     History of Changes
Other Study ID Numbers: 14595, 2009-012569-79
Study First Received: November 16, 2009
Last Updated: May 9, 2013
Health Authority: Australia: Human Research Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Germany: Federal Institute for Drugs and Medical Devices
Japan: Pharmaceuticals and Medical Devices Agency
United States: Food and Drug Administration

Keywords provided by Piramal Imaging SA:
Florbetaben
Amyloid beta-protein
Alzheimer's disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Dementia
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on November 25, 2014