Potential of Florbetapir F 18 PET to Inform Clinical Diagnosis and Management of Patients With Progressive Cognitive Decline

Inclusion Criteria:

• Are one of the following:

1. Group A: Recently completed (within the past 18 months) a comprehensive clinicalevaluation for progressive cognitive decline.

2. Group B: Currently being evaluated for progressive cognitive decline with furtherclinical or laboratory testing still planned.

• Have a site enrolling physician who has

1. less than high confidence in their diagnosis for the subject related to thecognitive decline at the time of enrollment. The level of confidence in thediagnosis should be rated by the physician as less than 85%, and should beinterpreted as the physician estimating that their diagnosis will be correct inless than 85% of patients with the same presentation as the subject; and

2. suspicion that the subject's cognitive decline is caused, at least in part, byAlzheimer's disease. The level of suspicion should be rated by the physician asthere being at least 15% of patients with the same presentation as the subjectwould have Alzheimer's disease;

• Can tolerate a 10 minute PET scan. The Principal Investigator will carefully assesseach subject and use sound medical judgment to determine whether the subject cantolerate the PET scan procedure;

• Have the ability to cooperate and comply with all study procedures;

• Have a study partner willing to accompany the subject on all of the study visits; and

• Give informed consent for study procedures (If the subject is incapable of givinginformed consent, the subject's designated decision maker may consent on behalf of thesubject but the subject must still confirm assent. This person may serve as the studypartner as well).

Exclusion Criteria:

• Subject or site enrolling physician knows the result of a previous amyloid imagingscan.

• Are considered medically unstable;

• Require additional laboratory tests or workup between enrollment and completion of theflorbetapir F 18 PET scan;

• Have a clinically significant infectious disease, including Acquired ImmunodeficiencySyndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection;

• Are receiving any investigational medications, or have participated in a trial withinvestigational medications within the last 30 days;

• Have ever participated in an experimental study with an amyloid targeting agent unlessit can be documented that the subject received only placebo during the course of thetrial;

• Have had a radiopharmaceutical imaging or treatment procedure within 7 days prior tothe study imaging session; or

• Are females of childbearing potential who are not surgically sterile, not refrainingfrom sexual activity or not using reliable methods of contraception. Females ofchildbearing potential must not be pregnant (negative serum β-hCG at the time ofscreening and negative urine β-hCG on the day of imaging) or breast feeding atscreening. Females must avoid becoming pregnant, and must agree to refrain from sexualactivity or to use reliable contraceptive methods such as prescribed birth control orintrauterine device (IUD) for 24 hours following administration of florbetapir F 18.