Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of PRX-03140 as Monotherapy in Subjects With Alzheimer's Disease

A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 monotherapy in subjects with Alzheimer's disease. The study consists of a 3-month double-blind treatment period and an optional 3-month extension period.

Inclusion Criteria:

• Men or Women with a clinical diagnosis of Probable AD
• MMSE score 16 to 24 inclusive
• Age >50 and <90 years
• Brain CT or MRI scan Consistent with a primary diagnosis of AD within 12 months
• Neurological examination without focal deficits (excluding changes attributable to peripheral nervous system disease, trauma or congenital birth deficits)
• No history or evidence of any other CNS disorder that could be interpreted as a cause of dementia
• No diagnosis of vascular dementia
• No history of significant psychiatric illness such as schizophrenia or bipolar affective disorder. Subjects with major depressive disorder on a stable dose of an antidepressant for >6 months may be eligible
• No evidence of the following: current vitamin B12 deficiency, positive syphilis serology, positive HIV test, or abnormalities in thyroid function
• No cognitive rehabilitation within 6 months of the study
• Subject has a regular caregiver willing to attend all study visits
• Signed informed consent by the subject (and legal guardian, if applicable)

Exclusion Criteria:

• No history of drug or alcohol abuse
• No clinically significant laboratory abnormalities or medical history
• No investigational drug within 30 days of Randomization
• Intolerance or allergy to cholinesterase inhibitors
• Cannot have been on cholinesterase inhibitors for AD for > 2 years
• If have been on cholinesterase inhibitors for < 2 years, must have been discontinued >= 2 months prior to randomization
• Cannot have received memantine within 2 months
• No clinically significant ECG abnormalities prior to randomization
• No history of uncontrolled seizure disorder within 12 months
• Cannot be taking MAO inhibitors, bupropion,fluoxetine, paroxetine, quinidine
• No history of malignancy within 3 years of randomization
• Women cannot be pregnant or breastfeeding