A Study of PRX-03140 in Subjects With Alzheimer’s Disease Receiving a Stable Dose of Donepezil

Overview

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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Primary Purpose: Treatment
  • Study Primary Completion Date: January 2010

Interventions

  • Drug: PRX-03140
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: PRX-03140
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary Measures

  • Alzheimer’s Disease Assessment Scale-Cognitive subscale.

Participating in This Clinical Trial

  • 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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