Clinical Trial: EPIX Pharmaceuticals Initiates Phase 2b Program In Alzheimer's Disease

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clipped from www.medicalnewstoday.com "We are encouraged by the PRX-03140 data we've seen to date, and based upon this, we are pleased to see EPIX begin the Phase 2b program with PRX-03140 in Alzheimer's disease," said Hugh Cowley, M.D., head of GSK's Center of Excellence for External Drug Discovery (CEEDD). "We believe that patients with Alzheimer's disease may ultimately be treated with combination therapy to manage the progression of the disease and to manage effectively the symptoms of Alzheimer's disease. As a result, we are evaluating PRX-03140 in a combination trial in concert with donepezil as well as in a monotherapy setting."

Phase 2 Double-Blind Study of PRX-03140 Monotherapy in Subjects With Alzheimer's Disease Receiving a Stable Dose of Donepezil

Detailed description of the Clinical Trial

Contacts
Contact: Julia Kazakin, MD 781-761-7646 jkazakin@epixpharma.com

Sponsors and Collaborators
Epix Pharmaceuticals, Inc.

Eligibility Criteria

* Men or Women with a clinical diagnosis of Probable AD
* MMSE score 12 to 22 inclusive
* Age >50 and <90>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

The Alzheimer's Action Plan: The Experts' Guide to the Best Diagnosis and Treatment for Memory Problems