stop_circleTerminated/Withdrawn

Alzheimer Disease

Bayer Identifier:

14595

ClinicalTrials.gov Identifier:

NCT01020838

EudraCT Number:

2009-012569-79

EU CT Number:

Not Available
STUDY SPONSORSHIP TRANSFERRED - Phase III study of Florbetaben (BAY94-9172) PET imaging for detection/exclusion of cerebral β-amyloid compared to histopathology

Trial purpose

DISCLAIMER: This study was originally conducted and disclosed under Bayer sponsorship; sponsorship was however transferred to a new sponsor while the study was still ongoing. Therefore, this disclosure overview only reflects the study status at the last time that Bayer was responsible for the study – for the latest correct status and details of the study, please refer to the disclosure by the new sponsor under the study’s NCT number on www.ClinicalTrials.gov.

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

Key Participants Requirements

Sex

Both

Age

21 Years
  • - 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.
  • - 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)

Trial summary

Enrollment Goal
216
Trial Dates
November 2009 - December 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
NEURACEQ (Florbetaben F-18, BAY94-9172)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Leipzig, 04103, Germany
Completed
Sun City, 85351, United States
Completed
Teaneck, 07666, United States
Completed
Stanford, 94305, United States
Completed
Tampa, 33616, United States
Completed
LILLE, 59037, France
Withdrawn
Itabashi-ku, 173-0015, Japan
Terminated
Toyohashi, 441-8124, Japan
Withdrawn
Toyohashi, 441-8029, Japan
Completed
Heidelberg, 3084, Australia
Completed
Jülich, 52425, Germany
Completed
San Antonio, 78229, United States
Terminated
Itabashi-ku, 173-0015, Japan
Terminated
Isezaki, 372-0006, Japan
Withdrawn
Hamamatsu, 432-8580, Japan
Completed
Dallas, 75390, United States
Completed
Philadelphia, 19104, United States
Withdrawn
Toyohashi, 440-0045, Japan
Withdrawn
Houston, 77030, United States
Completed
STRASBOURG, 67091, France

Primary Outcome

  • 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
    date_rangeTime Frame:
    On day 1 - one scanning period after injection
    enhanced_encryption
    Safety Issue:
    no

Secondary Outcome

  • 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
    date_rangeTime Frame:
    On day 1 - one scanning period after injection
    enhanced_encryption
    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
    date_rangeTime Frame:
    On day 1 - one scanning period after injection
    enhanced_encryption
    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
    date_rangeTime Frame:
    On day 1 - one scanning period after injection
    enhanced_encryption
    Safety Issue:
    no
  • To evaluate the safety and tolerability of a single dose of BAY94-9172
    date_rangeTime Frame:
    8 days
    enhanced_encryption
    Safety Issue:
    yes

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Diagnostic
Allocation
N/A
Blinding
Open Label
Assignment
Single Group Assignment
Trial Arms
1

Additional Information

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