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

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of PRX-03140 as Monotherapy in Subjects With Alzheimer's Disease

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.

Study Overview

• Status: Terminated
• Conditions: Alzheimer's Disease
• Intervention / Treatment: Drug: Placebo; Drug: Donepezil; Drug: PRX-03140

• Study Type: Interventional
• Enrollment (Anticipated): 236
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
    • Phoenix, Arizona, United States, 85050
      • PsyPharma Clinical Research, Inc.
    • Tucson, Arizona, United States, 85741-3537
      • Northwest NeuroSpecialists, PLLC
  • California
    • National City, California, United States, 91950
      • Synergy Clinical Research Center
    • Oxnard, California, United States, 93030
      • Pacific Neuroscience Medical Group
    • Sherman Oaks, California, United States, 91403
      • California Neuroscience Research Medical Group, Inc.
    • Torrance, California, United States, 90505
      • Torrance Clinical Research
  • Florida
    • Bradenton, Florida, United States, 34205
      • Bradenton Research Center
    • Delray Beach, Florida, United States, 33445
      • Brain Matters Research
    • Jacksonville, Florida, United States, 32216
      • Clinical Neuroscience Solutions, Inc.
    • Orlando, Florida, United States, 32806
      • Compass Research
    • Plantation, Florida, United States, 33317
      • Berma Research Group
    • St. Petersburg, Florida, United States, 33709
      • Meridien Research
    • Tampa, Florida, United States, 33613
      • Stedman Clinical Trials
    • Tampa, Florida, United States, 33617
      • Roskamp Institute
  • Kentucky
    • Paducah, Kentucky, United States, 42003
      • Four Rivers Clinical Research
  • Louisiana
    • Shreveport, Louisiana, United States, 71104
      • J. Gary Booker, MD, APMC
  • Maine
    • Scarborough, Maine, United States, 04074
      • Maine Neurology
  • Massachusetts
    • Norwood, Massachusetts, United States, 02062
      • The ICPS Group
  • New Jersey
    • Manchester, New Jersey, United States, 08759
      • Alzheimer's Research Corporation
    • Princeton, New Jersey, United States, 08540
      • Global Medical Institutes
  • New York
    • Brooklyn, New York, United States, 11235
      • Social Psychiatry Research Institute
    • New York, New York, United States, 10029
      • The Mount Sinai Medical Center
    • Staten Island, New York, United States, 10305
      • Behavioral Medical Research Of Staten Island
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • The Neurological Institute, P.A.
    • Morgantown, North Carolina, United States, 28655
      • MedArk
  • Ohio
    • Toledo, Ohio, United States, 43623
      • Neurology and Neuroscience Center of Ohio
  • Oklahoma
    • Tulsa, Oklahoma, United States, 74104
      • Tulsa Clinical Research, LLC
  • Rhode Island
    • East Providence, Rhode Island, United States, 02914
      • Rhode Island mood and memory research institute
  • Texas
    • Houston, Texas, United States, 77063
      • Todd Swick, MD, PA
  • Vermont
    • Bennington, Vermont, United States, 05201
      • The Memory Clinic
  • Virginia
    • Norfolk, Virginia, United States, 23507
      • The Glennan Center for Geriatrics & Gerontology, Eastern Virginia Medical School
    • Williamsburg, Virginia, United States, 23185
      • The Center for Excellence in Aging and Geriatric Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebo
Experimental: PRX-03140	Drug: PRX-03140
Active Comparator: donepezil	Drug: Donepezil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Alzheimer's Disease Assessment Scale-Cognitive subscale.

Collaborators and Investigators

• Sponsor: Epix Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start: May 1, 2008
• Primary Completion (Anticipated): January 1, 2010

Study Registration Dates

• First Submitted: May 30, 2008
• First Submitted That Met QC Criteria: June 5, 2008
• First Posted (Estimate): June 6, 2008

Study Record Updates

• Last Update Posted (Estimate): July 30, 2009
• Last Update Submitted That Met QC Criteria: July 28, 2009
• Last Verified: July 1, 2009

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Dementia; Tauopathies; Alzheimer Disease; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Enzyme Inhibitors; Nootropic Agents; Cholinesterase Inhibitors; Donepezil
• Other Study ID Numbers: Protocol 03140-203