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

• Status: Terminated
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Epix Pharmaceuticals, Inc.
• Treatments: Donepezil

Criteria

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