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.
Full Title of Study: “Phase 2 Double-Blind Study of PRX-03140 in Subjects With Alzheimer’s Disease Receiving a Stable Dose of Donepezil”
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
Gender Eligibility: All
Minimum Age: 50 Years
Maximum Age: 90 Years
Are Healthy Volunteers Accepted: No
Investigator Details
Lead Sponsor
Epix Pharmaceuticals, Inc.
Provider of Information About this Clinical Study
Elkan R. Gamzu, PhD, EPIX Pharmaceuticals, Inc
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