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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.
Ages:50 - 90
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
Sponsor: Epix Pharmaceuticals, Inc.
Phase: Phase 2
Trial ID: NCT00693004
Not Accepting Healthy Volunteers