Phase III Study of the Correlation Between Florbetapir F18 PET Imaging and Amyloid Pathology in the Brain

Inclusion Criteria (autopsy cohort):

• Have a projected life expectancy of ≤ 6 months as determined by the principalinvestigator (e.g. terminal medical condition) or are already enrolled in alongitudinal study of aging with an autopsy component;

• Can tolerate a 10 minute PET scan; and

• Give informed consent for study procedures and brain donation consistent with thelegal requirements of the State in which they are enrolled and the State in which theydie. Inclusion Criteria (specificity cohort):

• Cognitively and neurologically healthy males and females 18 to 40 years of age;

• Who had no known risk factors for AD, including:

• Known genetic risk factors for AD, including an ApoE ε4 allele (note: ApoE genotypewas determined after enrollment and was not disclosed to healthy control subjects).Scans from subjects carrying an ApoE ε4 allele were not included in the primaryspecificity analysis, but were included in an exploratory analysis;

• First degree relative with a known progressive dementing disorder;

• History of cognitive decline;

• History of neurologic, neurodegenerative, or psychiatric disease;

• History of head trauma; or

• Evidence of brain abnormality on a MRI scan;

• Who performed in an age-appropriate normal range on the Wechsler Logical Memory I &II, story A;

• Who could tolerate a 10-minute PET scan; and

• Who provided informed consent before any study procedures were performed.

Exclusion Criteria:

• Have primary brain tumor, known metastases to the brain, central nervous system (CNS)lymphoma;

• Have any major, focal structural loss of brain matter;

• Are aggressively being treated with life sustaining measures (e.g. currently onrespirator; receiving high dose chemotherapy);

• Have a clinically significant infectious disease, including Acquired Immune DeficiencySyndrome (AIDS), Human Immunodeficiency Virus (HIV) infection, previous positive testfor hepatitis or HIV or Creutzfeldt-Jakob disease (CJD);

• 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 (e.g.anti-amyloid immunotherapy, secretase inhibitor);

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

• Are females of childbearing potential who are pregnant or not using adequatecontraception.