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

July 28, 2009 updated by: Epix Pharmaceuticals, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

420

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • 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.
      • Ocala, Florida, United States, 34471
        • Renstar Medical Research
      • 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
    • Illinois
      • Elk Grove Village, Illinois, United States, 60007
        • Alexian Brothers Neroscience Institute
    • Kentucky
      • Paducah, Kentucky, United States, 42003
        • Four Rivers Clinical Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71104
        • J. Gary Booker, Md
    • Maine
      • Scarborough, Maine, United States, 04074
        • Maine Neurology
    • Massachusetts
      • Norwood, Massachusetts, United States, 02062
        • The ICPS Group
    • New Jersey
      • Long Beach, New Jersey, United States, 07740
        • Memory Center of America
      • Manchester, New Jersey, United States, 08759
        • Alzheimer's Research Corporation
      • Princeton, New Jersey, United States, 08540
        • Global Medical Institutes
    • New York
      • Albany, New York, United States, 12208
        • Neurological Associates of Albany, P.C.
      • 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
        • RI Mood and Memory Research Institute
    • Texas
      • Houston, Texas, United States, 77063
        • Todd Swick, MD, PA
    • Vermont
      • Bennington, Vermont, United States, 05201
        • The Memory Clinic
      • Burlington, Vermont, United States, 05401
        • University of Vermont
    • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Epix Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Anticipated)

January 1, 2010

Study Registration Dates

First Submitted

May 2, 2008

First Submitted That Met QC Criteria

May 5, 2008

First Posted (Estimate)

May 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

Other Study ID Numbers

  • Protocol 01340-202

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Alzheimer's Disease

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Norway

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe