Rasagiline 1 mg and 2 mg Added to Aricept 10 mg Daily in Patients With Mild to Moderate Alzheimer's Disease (AD)

Exclusion Criteria

• •1. Patients taking (a) Aricept® doses other than 10 mg daily (or 10 mg for \< 8 weeks); (b) other medications for Alzheimer's Disease except for stable, prescribed doses of 20 mg daily memantine for at least 4 weeks (preceded by titration to 20 mg daily).
• •2. No reliable caregiver.
• •3. Neurological disorders affecting cognition or the ability to assess it that are not associated with Alzheimer's Disease, such as Parkinson's disease, multi-infarct dementia, dementia due to cerebrovascular disease, Huntington's disease, Pick's disease, Creutzfeld-Jacob disease, Lewy Body disease, normal pressure hydrocephalus, brain tumor, progressive supranuclear palsy, seizure disorder, subdural hematoma, or multiple sclerosis, as well as patients with human immunodeficiency virus (HIV) disease, neurosyphilis, or a history of significant head trauma followed by persistent neurological deficits or known structural brain abnormalities.
• •4. Psychiatric disorders affecting the ability to assess cognition such as schizophrenia, bipolar or unipolar depression, and sleep disorders.
• •5. Dementia complicated by other organic disease or Alzheimer's Disease with delusions (DSM 290.20 or 290.12), delirium (DSM 290.30 or 290.11), or depression (DSM 290.21 or 290.13).
• •6. Drug or alcohol abuse or dependence in \<= 5 years by DSM IV criteria.
• •7. Any active or clinically significant conditions affecting absorption, distribution, or metabolism of the study medication (e.g., inflammatory bowel disease, gastric or duodenal ulcers, hepatic disease, or severe lactose intolerance).
• •8. Uncontrolled hypertension (sitting systolic \>= 160 mmHg and/or diastolic \>= 95 mmHg) as assessed by the Investigator regardless of whether or not the patient is taking antihypertensive medications.
• •9. Insulin-dependent diabetes or diabetes not stabilized by diet and/or oral hypoglycemic agents as demonstrated by an Hb A1c of \> 8.0% or a random serum glucose value of \> 170 mg/dL.
• •10. Evidence of clinically significant, active gastrointestinal, renal, hepatic, respiratory, endocrine, or cardiovascular system disease. Patients with right bundle branch block (complete or partial) may be included in the study, but patients with left bundle branch block are excluded.
• •11. History of malignant neoplasms (does not include basal or squamous cell carcinoma of the skin) treated within 5 years prior to study entry, current evidence of malignant neoplasm, recurrent, metastatic disease, or major risk factors for malignant melanoma (xeroderma pigmentosum, personal history of melanoma, more than 100 moles, and puva or other radiotherapy.
• •12. Donation of blood or blood products during 30 days prior to Screening or plans to donate blood while participating in the study or within 30 days after completion of the study.
• •13. Women who are pregnant or breast-feeding.
• •14. Patients and/or caregivers who are unwilling or unable to fulfill the requirements of the study.
• •15. Known hypersensitivity to cholinesterase inhibitors or MAO or MAO-B inhibitors.
• •16. Use of any unapproved prior or concomitant medications, including:
• •* Recent (\<= 12 weeks) or concomitant use of other MAO inhibitors.
• •* Recent (\<= 6 weeks) or concomitant use of SSRIs. (SSRIs and tricyclic and tetracyclic antidepressants in low doses are permissible, as follows: citalopram \<= 20 mg daily, escitalopram \<= 10 mg daily, and sertraline 25-100 mg daily).
• •* Recent (\<= 1 week) or concomitant use of sympathomimetics (including ephedra supplements).
• •* Recent (\<= 1 week) or concomitant use of meperidine.
• •* Recent (\<= 1 week) or concomitant use of dextromethorphan.
• •* Recent (\<= 1 week) or concomitant use of gentamicin.
• •17. Any condition that would make the patient or the caregiver, in the opinion of the Investigator, unsuitable for the study.
• •18. Involvement in any other investigational trial in the preceding 3 months or likely involvement in any other investigational trial during the course of this study.
• •19. Contraindications to MRI scanning, including CNS aneurysm clips, implanted neural stimulators, implanted cardiac pacemakers or defibrillators, cochlear implants, metallic ocular foreign body, insulin pump, or metal shrapnel or bullet.