1. Males or females greater than or equal to 50 years of age.
2. Diagnosis of Alzheimer's Disease according to Diagnostic and Statistical Manual of
Mental Disorders, Fourth Edition, Text Revision (DSM-IV TR) and Mini Mental State Exam
between 10 and 24, inclusive and Modified Hachinski Ischemia Score less than or equal
to 4.
3. Brain imaging such as MRI and/or CT within one year of enrollment.
4. Subjects must have a guardian or caregiver who assists the subject at least 5 days per
week (at least 3 hours/day).
5. Subjects must be able to cooperate with drug administration (including the ability to
ingest oral medications) and study procedures and abide by study restrictions.
6. Subjects must have at least 6 years of prior education and should have previously (in
pre-Alzheimer's condition) been capable of reading, writing and communicating
effectively with others.
7. Subjects must be willing and able to give informed consent or have a mentally
competent legal representative authorized to provide informed consent on their behalf.
8. Residence in an assisted care facility is allowed if subject is living independently.
1. Major structural brain disease
2. Major medical illness or unstable medical condition within 6 months of screening that
may interfere with the subject's ability to comply with study procedures and abide by
study restrictions.
3. Residence in a nursing home or assisted care facility that provides the subject with
24-hour care and supervision.
4. Women who are pregnant, nursing, or if of child-bearing potential not using a
medically accepted, highly effective method of birth control.
5. Active alcohol dependence or drug abuse.
6. Use of the following medications within 60 days prior to enrollment:cognition
enhancing agents, narcotic analgesics, low potency neuroleptics, antihypertensive
agents with frequent Central Nervous System (CNS) side effects, anti-Parkinsonian
medications, medications with central anticholinergic activity, medications for
epilepsy, lithium.
7. Participation in an investigational drug or device study within 30 days prior to study
entry, or 60 days prior to study entry if the investigational drug study involved
therapy for Alzheimer's Disease.