Short Term Effects of PRX-03140 in Patients With Mild Alzheimer's Disease Being Treated With Aricept

January 29, 2008 updated by: Epix Pharmaceuticals, Inc.

A Randomized, Double-Blind, Placebo-Controlled, Phase IIa Study to Assess the Short-Term Effects of PRX-03140 Alone and in Combination With Donepezil in Subjects With Mild Alzheimer's Disease.

This is a study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of PRX-03140 administered orally once daily for 14 days in subjects with mild Alzheimer's Disease who are using a stable, well-tolerated 10 mg dose of Aricept (donepezil) but continue to experience worsening AD symptoms.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

80

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
    • California
      • Paramount, California, United States, 90723
        • California Clinical Trials Medical Group, Inc
      • Rancho Mirage, California, United States, 94109
        • Southwest Clinical Research
      • San Diego, California, United States, 92103
        • Pacific Research Network, Inc
      • San Francisco, California, United States, 94109
        • San Francisco Clinical Research Center
      • Torrance, California, United States, 90505
        • Torrance Clinical Research
    • Connecticut
      • Darien, Connecticut, United States, 06820
        • Research Center for Clinical Studies
    • Florida
      • Miami, Florida, United States, 33137
        • Miami Jewish Home and Hospital for the Aged
      • Plantation, Florida, United States, 33317
        • Berma Research
      • St Petersburg, Florida, United States, 33709
        • Meridien Research
      • St. Petersburg, Florida, United States, 33702
        • Comprehensive NeuroScience, Inc
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Atlanta Center for Medical Research
    • Louisiana
      • Shreveport, Louisiana, United States, 71104
        • J. Gary Booker, Md
    • Massachusetts
      • Pittsfield, Massachusetts, United States, 01201
        • Neuroscience Research of the Berkshires
    • Ohio
      • Dayton, Ohio, United States, 45408
        • Neurology Specialists
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Saint Johns Office Building
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States, 19046
        • The Clinical Trial Center, LLC
    • South Carolina
      • Greenville, South Carolina, United States, 29615
        • Alliance for Neuro Research, LLC

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

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • At least 60 years old.
  • On a stable 10 mg dose of Aricept for at least 90 days and able to take it in the morning.
  • Diagnosis of probable Alzheimer's Disease.
  • Mild dementia.
  • You or your authorized representative provide voluntary written informed consent.
  • Not pregnant, planning a pregnancy, or capable of becoming pregnant.

Exclusion Criteria:

  • Any other medical condition which, in the opinion of the Investigator, would jeopardize your safety, impact the validity of the study results, or interfere with your ability to complete the study according to the protocol.
  • Intolerance to Aricept.
  • Dementia other than Alzheimer's type.
  • Parkinson's Disease.
  • History of seizure or epilepsy.
  • History of stroke.
  • Participation in another research study within last 30 days.
  • Enrollment in any previous research study testing PRX-03140.
  • Use of prescription cognitive enhancing medications (except Aricept) or MAO inhibitors within last 4 weeks.
  • Use of tobacco products within last 4 weeks.
  • Positive blood screen for Hepatitis B surface antigen or Hepatitis C antibody.
  • Positive urine screen for alcohol or drugs of abuse or history of drug or alcohol abuse within last 6 months.
  • Major surgery within last 4 weeks.

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
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Safety and tolerability of PRX-03140 during 2 weeks of treatment.
Electroencephalogram (EEG) changes through 14 days of treatment.

Secondary Outcome Measures

Outcome Measure
Changes in cognition after 2 weeks of treatment.
Blood concentrations of PRX-03140 and Aricept during 14 days of treatment.

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

October 1, 2006

Primary Completion (Actual)

October 1, 2007

Study Registration Dates

First Submitted

October 4, 2006

First Submitted That Met QC Criteria

October 4, 2006

First Posted (Estimate)

October 6, 2006

Study Record Updates

Last Update Posted (Estimate)

January 30, 2008

Last Update Submitted That Met QC Criteria

January 29, 2008

Last Verified

January 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRX-CP-018

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.

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