Comparative Study to Test Safety and Efficacy of Neurotrophic and Cholinergic Treatment of Alzheimer's Disease

Exclusion Criteria

• •Any clinically significant laboratory abnormalities on the battery of screening tests
• •Patients who in the past have not tolerated treatment with 10 mg Aricept or treatment with a corresponding dose of another cholinesterase inhibitor
• •Severe psychotic features, depression, agitation or behavioral problems within the last three months that could lead to difficulty complying with the protocol
• •Any significant systemic illness or unstable medical condition that could lead to difficulty complying with the protocol
• •Patients who in the Investigator's opinion would not comply with study procedures
• •Any significant neurological disease other than Alzheimer's Disease, within the past five years, or with residual effects
• •Delusional symptoms are often characteristic of Alzheimer's Disease, but patients with symptoms so pronounced that they warrant an alternative diagnosis are excluded
• •History of alcohol or substance abuse or dependence within the past two years (DSM-IV)
• •History of schizophrenia (DSM-IV)
• •Patients with a history of systemic cancer within the past two years are excluded
• •History of myocardial infarction in the past year or unstable or severe cardiovascular disease, including uncontrolled hypertension
• •Uncontrolled insulin-requiring diabetes or non-insulin dependent diabetes mellitus (Haemoglobin A1c \[HBA1c\] \> 10.0)
• •Use of:
• •* systemic corticosteroids for more than one week within three months prior to Baseline (BL)
• •* Anti-Parkinsonian agents within two months prior to baseline (BL)
• •* Approved or investigational Cholinesterase Inhibitors within 30 days or five half-lives, whichever is longer, prior to BL
• •* Memantine or other N-methyl-D-aspartic acid (NMDA) antagonists within 30 days or five half-lives, whichever is longer, prior to BL
• •* Treatment with high potency neuroleptics or narcotic analgesics within four weeks prior to BL
• •* Cimetidine within four weeks prior to BL
• •* Sedatives more frequently than two times per week for sleep within four weeks prior to BL