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A randomized placebo-controlled study to evaluate the efficacy of PRX-03140 in subjects with
Alzheimer's Disease receiving a stable dose of donepezil. The study consists of a 26-week
double-blind treatment period.
Ages:50 - 90
- Men or Women with a clinical diagnosis of Probable AD - MMSE score 12 to 22 inclusive - Age >50 and <90 years - Received at least 4 months of a stable dose of donepezil 10mg QD for AD - Brain CT or MRI scan Consistent with a primary diagnosis of AD within 24 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) - No history of drug or alcohol abuse - No clinically significant laboratory abnormalities or medical history - No investigational drug within 30 days of Randomization - Cannot receive memantine within 2 months of enrollment - No other prescription acetylcholinesterase inhibitors for AD (other than donepezil) within 4 months of enrollment - No clinically significant ECG abnormalities or cardiac history - No history of uncontrolled seizure disorder within 12 months of enrollment - 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: NCT00672945
Not Accepting Healthy Volunteers