PET Imaging Study Using [11C]PIB in Subjects With AD & Healthy Volunteers

The objectives of the study are:

1. To perform PET scans with [11C]PIB to use for direct (i.e., same-subjects) comparison of
[11C]PIB and [18F]AV-45

2. To establish the most effective and reliable PET imaging method to detect amyloid
deposition in AD, in order to understand disease progression and subsequently evaluate
treatment effects.

3. To ascertain a PET imaging method that will minimize discomfort for subjects, thus
increasing the potential for clinical follow-up scans, by reducing the patient burden
and potential cost of future PET examinations.

A separate protocol/study will be conducted using [18F] AV-45. Participants who enroll in
this protocol using [11C] PIB will be consented to participate in the [18F] AV-45 (IRB #
NA_00033155) protocol/study as it is a mandatory requirement that participants participate in
both protocols.Up to 20 participants with mild to moderate Alzheimer's Disease and 10 healthy
volunteers will participate in this study.

Inclusion Criteria:

- Male or female subjects at least 18 years of age

- Subjects who in the opinion of the investigator based on medical history and physical
exam can tolerate the PET scan procedures

Exclusion Criteria:

- Have clinically significant hepatic, renal, pulmonary, metabolic, or endocrine
disturbances

- Have current clinically significant cardiovascular disease.

- Have a history of drug or alcohol abuse within the last year, or prior prolonged
history of abuse

- Have a clinically significant infectious disease, including Acquired Immune Deficiency
Syndrome (AIDS) or Human Immunodeficiency Virus (HIV) infection or previous positive
test for hepatitis

- Women of childbearing potential must not be pregnant (negative urine beta-hCG at the
time of screening and negative urine beta-hCG on the day of imaging) or lactating at
screening or at day of imaging

- Have a history of relevant severe drug allergy or hypersensitivity (Relevant severe
drug allergies should be determined by the PI, and any questions about a subject's
eligibility can be directed to Avid. If a subject has a history of severe drug
allergies, it may be dangerous for them to participate in a study with a novel
compound

- Have received an investigational medication within the last 30 days. Current
clinically significant or unstable medical comorbidities, as indicated by history or
physical exam

- Have received a radiopharmaceutical for imaging or therapy within the past 7 days
prior to the imaging session for this study

- Body weight > 300 pounds

- History of significant radiation exposure

- Participants with pacemakers, implanted electronic hearing devices, aneurysm clips,
shrapnel, unallowed prosthetic or other metallic device in their bodies

- Pre-existing CNS disease (other than dementia), endocrine, or severe cardiovascular
disease (MI, CABG, angioplasty)