A Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of [18F]NAV4694 PET for Detection of Cerebral Beta-Amyloid When Compared With Postmortem Histopathology

Inclusion Criteria

• •Male or female subjects will be at least 21 years of age.
• •Subjects will have a life expectancy of approximately 6 months
• •Subject health is adequate as determined by the investigator to receive \[18F\]NAV4694
• •Female subjects will not be of child-bearing potential or will have a negative urine pregnancy test on day of \[18F\]NAV4694 injection.
• •Must exhibit adequate visual, auditory, and communication capabilities to enable compliance with study procedures. This includes being able to lie down flat in the MRI or CT and PET scanner for a period of approximately 1 hour.
• •Subjects must be willing to donate their brains for post mortem examination upon death (this consent can be obtained in the manner specific to the country/region involved).
• •Subjects have 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 (LAR) (for individuals with dementia).