Phase III Study of Florbetaben (BAY94-9172) PET Imaging for Detection/Exclusion of Cerebral β-amyloid Compared to Histopathology
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Intervention: Florbetaben (BAY94-9172)
Intervention description: Single intravenous injection 1-5ml, 300 MBq (+/- 20%)
Phase: Phase 3
Study type: Interventional
Primary purpose: Diagnostic
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 218.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No
Keywords: Florbetaben; Amyloid beta-protein; Alzheimer's disease

Summary:

      To determine the sensitivity and specificity of the visual assessment of 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
    

Eligibility 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)