Magnetic Resonance Spectroscopy Study of Memantine in Alzheimer's Disease

Exclusion Criteria

• •Clinically significant vitamin B12 deficiency at Screening.
• •Patients with a modified Hachinski ischemia score greater than 4 at Screening.
• •Patients with evidence of clinically significant and active pulmonary, gastrointestinal, renal, hepatic, endocrine, or cardiovascular system disease. Patients with controlled hypertension and right bundle branch block (complete or partial) may be included in the study. Patients with thyroid disease may also be included in the study provided they are euthyroid on treatment. Patients with controlled diabetes may also be included.
• •Patients with severe renal impairment (estimated creatinine clearance \< 35 mL/min).
• •Patients with systolic blood pressure (while sitting) greater then than 180 mm Hg or less then 90 mm Hg, or diastolic blood pressure (while sitting) greater than 100 mm Hg or less than 50 mm Hg at Screening.
• •Patients with evidence of other neurological disorders including, but not limited to, stroke, Parkinson's disease, seizure disorder, hydrocephalus, or head injury with loss of consciousness within the past five years at Screening.
• •Patients with a current DSM-IV Axis I disorder other than Alzheimer's disease, including schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic disorder, or post-traumatic stress disorder.
• •Patients with dementia complicated by other organic disease.
• •Patients who have had a previous brain scan (MRI or CT) with results inconsistent with a diagnosis of probable Alzheimer's disease.
• •Patients with an oncological diagnosis (hematological or solid tumor) which is currently being treated, or for which there has been treatment within the year preceding Screening, or for which there is still evidence of active disease. (Note: Patients with local dermatological tumors at such as basal or squamous cell carcinoma may be included.)
• •Patients with an object in the head or neck which would invalidate or obstruct the successful completion of an MRI scan, or patients who have other contraindications to MRI, including those with implanted ferromagnetic material or devices such as cardiac pacemakers, deep brain stimulators, cochlear implants, or intraocular metallic shards.
• •Patients who are claustrophobic and/or unable to tolerate MRI at Screening, or whom the Investigator believes will not be able to tolerate further scans scheduled during the course of the study.
• •Patients with a known or suspected history (within the past 5 years at Screening) of alcoholism or drug abuse.
• •Patients who are on an unstable dose of a cholinesterase inhibitor (donepezil, rivastigmine, or galantamine), are currently taking more than one cholinesterase inhibitor at Screening, who are likely to require a change in cholinesterase drug dose during the course of the study, or for whom a cholinesterase inhibitor therapy is contraindicated.
• •Patients with a history of severe drug allergy or hypersensitivity, or patients with known hypersensitivity to memantine, amantadine, rimantadine, or lactose.
• •Patients who have been previously treated with or have participated in an investigational study of neramexane, memantine, or amantadine.
• •Patients previously treated with commercial memantine.
• •Patients who have been in an investigational drug study or who have received treatment with an investigational drug within 30 days or 5 half-lives (whichever is longer) of Screening.
• •Patients or caregivers who are unwilling or unable to abide by the visit schedule and other requirements of the study.
• •Any condition which would make the patient or caregiver unsuitable for the study in the opinion of the Investigator.