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

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.