Analysis of 18F-AV-1451 PET Imaging in Cognitively Healthy, MCI and AD Subjects

Inclusion Criteria:

Exploratory Cognitively Healthy Subjects

- ≥ 20 to ≤ 40 years of age OR ≥ 50 years of age

- Mini-mental state examination (MMSE) ≥ 29

- No significant history of cognitive impairment

Exploratory MCI Subjects

- ≥ 50 years of age

- MMSE ≥ 24

- Have MCI consistent with National Institute on Aging-Alzheimer's Association (NIA-AA)
working group's diagnostic guidelines for AD

- Have a study partner that can report on subject's activities of daily living

Exploratory AD Subjects

- ≥ 50 years of age

- MMSE > 10

- Have possible or probable AD based on the NIA-AA working group's diagnostic guidelines
for AD

- Have a study partner that can report on subject's activities of daily living

Confirmatory Subjects

- ≥ 50 years of age

- MMSE ≥ 20 and ≤ 27

- Cognitively impaired subjects with either MCI or dementia with a suspected
neurodegenerative cause

- Have a study partner that can report on subject's activities of daily living

Exclusion Criteria:

- Current clinically significant psychiatric disease

- Evidence of structural brain abnormalities

- History of moderate or severe traumatic brain injury

- Current clinically significant cardiovascular disease or ECG abnormalities, or
additional risk factors for Torsades de Pointes

- Current clinically significant infectious disease, endocrine or metabolic disease,
pulmonary, renal or hepatic impairment, or cancer

- History of alcohol or substance abuse or dependence

- Females of childbearing potential who are not surgically sterile, not refraining from
sexual activity or not using reliable methods of contraception

- Have received or participated in a trial with investigational medications in the past
30 days

- Have had a non-study related radiopharmaceutical imaging or treatment procedure within
7 days prior to the study imaging session.