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

This study has been terminated.
(Myriad has discontinued the development of Flurizan.)
Sponsor:
Information provided by:
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00380276
First received: September 21, 2006
Last updated: August 1, 2008
Last verified: August 2008
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: MPC-7869
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type

Resource links provided by NLM:


Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:
  • Primary Safety [ Time Frame: For study duration ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: September 2006
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
Open Label Arm
Treatment is open-label
Drug: MPC-7869
800 mg BID Oral dosing

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380276

  Hide Study Locations
Locations
United States, Alabama
Alabaster, Alabama, United States
Huntsville, Alabama, United States
United States, Arizona
Phoenix, Arizona, United States
Sun City, Arizona, United States
Tucson, Arizona, United States
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
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Sacramento, California, United States
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San Francisco, California, United States
Vista, California, United States
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Danbury, Connecticut, United States
Darien, Connecticut, United States
New Haven, Connecticut, United States
United States, District of Columbia
Washington D.C, District of Columbia, United States
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
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Chicago, Illinois, United States
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Fort Wayne, Indiana, United States
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United States, Kentucky
Lexington, Kentucky, United States
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Baltimore, Maryland, United States
Glen Burnie, Maryland, United States
United States, Massachusetts
Boston, Massachusetts, United States
West Yarmouth, Massachusetts, United States
United States, Michigan
Ann Arbor, Michigan, United States
Grand Rapids, Michigan, United States
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Rochester, Minnesota, United States
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St. Louis, Missouri, United States
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Lebanon, New Hampshire, United States
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Albuquerque, New Mexico, United States
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Albany, New York, United States
Brooklyn, New York, United States
Elmsford, New York, United States
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Rochester, New York, United States
Syracuse, New York, United States
United States, North Carolina
Durham, North Carolina, United States
Raleigh, North Carolina, United States
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Centerville, Ohio, United States
Columbus, Ohio, United States
Toledo, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Eugene, Oregon, United States
Portland, Oregon, United States
United States, Pennsylvania
Jenkintown, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburg, Pennsylvania, United States
Scotland, Pennsylvania, United States
United States, Rhode Island
East Providence, Rhode Island, United States
United States, South Carolina
Beaufort, South Carolina, United States
Charleston, South Carolina, United States
Greer, South Carolina, United States
United States, Tennessee
Memphis, Tennessee, United States
Nashville, Tennessee, United States
United States, Texas
Dallas, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
United States, Utah
Ogden, Utah, United States
Salt Lake City, Utah, United States
United States, Vermont
Bennington, Vermont, United States
United States, Virginia
Alexandria, Virginia, United States
Charlottesville, Virginia, United States
Virginia Beach, Virginia, United States
United States, Wisconsin
Middleton, Wisconsin, United States
Milwaukee, Wisconsin, United States
Canada, Manitoba
Winnepeg, Manitoba, Canada
Canada, Nova Scotia
Halifax, Nova Scotia, Canada
Canada, Ontario
Kingston, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Canada, Saskatchewan
Regina, Saskatchewan, Canada
Sponsors and Collaborators
Myrexis Inc.
Investigators
Study Director: Mark Laughlin, MD Myrexis Inc.
  More Information

No publications provided

Responsible Party: Ed Swabb, MD, Myriad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00380276     History of Changes
Other Study ID Numbers: MPC-7869-05-009
Study First Received: September 21, 2006
Last Updated: August 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:
Alzheimer's
Dementia
Dementia of Alzheimer Type

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on October 19, 2014