Alzheimer's Disease
Conditions
Brief summary
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.
Interventions
Sponsors
Epix Pharmaceuticals, Inc.
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
50 Years to 90 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Alzheimer's Disease Assessment Scale-Cognitive subscale. | — |
Countries
United States
Outcome results
None listed