A Study of Two Doses of 18F-AV-45 in Alzheimer's Disease and Healthy Volunteers

Inclusion Criteria (AD group):

- Greater than 50 years of age

- Probable AD according to the National Institute of Neurological and Communication
Disorders and Stroke-Alzheimer's Disease and Related Disorders Association
(NINCDS-ADRDA) criteria

- Mild/moderate dementia as evidenced by a Mini-Mental State Examination (MMSE) score
ranging from 10 to 24, boundaries included, at screening

- History of cognitive decline gradual in onset and progressive over a period of at
least 6 months

Inclusion Criteria (healthy volunteer group):

- 35 to 55 years of age, inclusive

- MMSE of 29 or greater

Exclusion Criteria (both groups):

- Neurodegenerative disorders other than AD, including, but not limited to Parkinson's
disease, Pick's disease, fronto-temporal dementia, Huntington's chorea, Down
syndrome, Creutzfeldt-Jacob disease, normal pressure hydrocephalus, and progressive
supranuclear palsy

- Diagnosis of other dementing / neurodegenerative disease

- Diagnosis of mixed dementia

- Cognitive impairment resulting from trauma, hypoxic damage, vitamin deficiency,
brain infection, brain cancer, endocrine disease, or mental retardation

- Clinically significant infarct or possible multi-infarct dementia as defined by the
NINCDS criteria

- Evidence on screening MRI or other biomarker that suggests alternate etiology for
cognitive deficit (for healthy controls, evidence suggesting the presence of AD
pathology)

- Clinically significant psychiatric disease

- History of epilepsy or convulsions

- Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine
disturbances

- Current clinically significant cardiovascular disease

- Received investigational medication within the last 30 days