Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol

August 1, 2008 updated by: Myrexis Inc.

Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type

Open-label treatment with MPC-7869 for participants in a previous randomized study.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Phase 3

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

  • Canada
    • Manitoba
      • Winnepeg, Manitoba, Canada
    • Nova Scotia
      • Halifax, Nova Scotia, Canada
    • Ontario
      • Kingston, Ontario, Canada
      • Ottawa, Ontario, Canada
      • Toronto, Ontario, Canada
    • Saskatchewan
      • Regina, Saskatchewan, Canada
  • United States
    • Alabama
      • Alabaster, Alabama, United States
      • Huntsville, Alabama, United States
    • Arizona
      • Phoenix, Arizona, United States
      • Sun City, Arizona, United States
      • Tucson, Arizona, United States
    • California
      • Costa Mesa, California, United States
      • Irvine, California, United States
      • Lafayette, California, United States
      • Laguna Hills, California, United States
      • Long Beach, California, United States
      • Rancho Mirage, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • San Francisco, California, United States
      • Vista, California, United States
    • Connecticut
      • Danbury, Connecticut, United States
      • Darien, Connecticut, United States
      • New Haven, Connecticut, United States
    • District of Columbia
      • Washington D.C, District of Columbia, United States
    • Florida
      • Deerfield Beach, Florida, United States
      • Fort Myers, Florida, United States
      • Ft Meyers, Florida, United States
      • Hollywood, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Naples, Florida, United States
      • Sunrise, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Fort Wayne, Indiana, United States
      • Indianapolis, Indiana, United States
    • Kentucky
      • Lexington, Kentucky, United States
    • Maryland
      • Baltimore, Maryland, United States
      • Glen Burnie, Maryland, United States
    • Massachusetts
      • Boston, Massachusetts, United States
      • West Yarmouth, Massachusetts, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Grand Rapids, Michigan, United States
    • Minnesota
      • Rochester, Minnesota, United States
    • Missouri
      • St. Louis, Missouri, United States
    • New Hampshire
      • Lebanon, New Hampshire, United States
    • New Jersey
      • Kenilworth, New Jersey, United States
      • Morristown, New Jersey, United States
      • Princeton, New Jersey, United States
      • Stratford, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Brooklyn, New York, United States
      • Elmsford, New York, United States
      • New York, New York, United States
      • Olean, New York, United States
      • Rochester, New York, United States
      • Syracuse, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Centerville, Ohio, United States
      • Columbus, Ohio, United States
      • Toledo, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Jenkintown, Pennsylvania, United States
      • Philadelphia, Pennsylvania, United States
      • Pittsburg, Pennsylvania, United States
      • Scotland, Pennsylvania, United States
    • Rhode Island
      • East Providence, Rhode Island, United States
    • South Carolina
      • Beaufort, South Carolina, United States
      • Charleston, South Carolina, United States
      • Greer, South Carolina, United States
    • Tennessee
      • Memphis, Tennessee, United States
      • Nashville, Tennessee, United States
    • Texas
      • Dallas, Texas, United States
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Ogden, Utah, United States
      • Salt Lake City, Utah, United States
    • Vermont
      • Bennington, Vermont, United States
    • Virginia
      • Alexandria, Virginia, United States
      • Charlottesville, Virginia, United States
      • Virginia Beach, Virginia, United States
    • Wisconsin
      • Middleton, Wisconsin, United States
      • Milwaukee, Wisconsin, United States

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

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participation in a previous MPC-7869 randomized protocol
  • Have had a diagnosis of probable Alzheimer's disease.
  • Men or women ages 55 years or greater and living in the community at the time of enrollment (i.e., not living in a rest home or nursing care facility).
  • Signed the subject Informed Consent Form and is willing and able to participate for the duration of the study.
  • Female subjects must be surgically sterile or postmenopausal for > 1 year.
  • Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria:

  • History or evidence of, active malignancy, except for basal cell carcinoma or squamous cell carcinoma of the skin, within the 24 months prior to entry. Men with prostate cancer may be enrolled at the discretion of the sponsor.
  • Chronic or acute renal, hepatic or metabolic disorder.
  • Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Open Label Arm
Treatment is open-label
Drug: MPC-7869
800 mg BID Oral dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Primary Safety
Time Frame: For study duration
For study duration

Collaborators and Investigators

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

Sponsor

Myrexis Inc.

Investigators

  • Study Director: Mark Laughlin, MD, Myrexis 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

September 1, 2006

Study Completion (Anticipated)

December 1, 2008

Study Registration Dates

First Submitted

September 21, 2006

First Submitted That Met QC Criteria

September 22, 2006

First Posted (Estimate)

September 25, 2006

Study Record Updates

Last Update Posted (Estimate)

August 5, 2008

Last Update Submitted That Met QC Criteria

August 1, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MPC-7869-05-009

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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