NCT00380276

Brief Summary

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

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Sep 2006

Geographic Reach
2 countries

90 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 25, 2006

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
Last Updated

August 5, 2008

Status Verified

August 1, 2008

First QC Date

September 21, 2006

Last Update Submit

August 1, 2008

Conditions

Keywords

Alzheimer'sDementiaDementia of Alzheimer Type

Outcome Measures

Primary Outcomes (1)

  • Primary Safety

    For study duration

Study Arms (1)

Open Label Arm

OTHER

Treatment is open-label

Drug: MPC-7869

Interventions

800 mg BID Oral dosing

Open Label Arm

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (90)

Unknown Facility

Alabaster, Alabama, United States

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Huntsville, Alabama, United States

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Phoenix, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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Costa Mesa, California, United States

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Irvine, California, United States

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Lafayette, California, United States

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Laguna Hills, California, United States

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Long Beach, California, United States

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Rancho Mirage, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Francisco, California, United States

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Vista, California, United States

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Danbury, Connecticut, United States

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Darien, Connecticut, United States

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New Haven, Connecticut, United States

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Washington D.C., District of Columbia, United States

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Deerfield Beach, Florida, United States

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Fort Meyers, Florida, United States

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Fort Myers, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, Florida, United States

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Miami, Florida, United States

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Naples, Florida, United States

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Sunrise, Florida, United States

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Tampa, Florida, United States

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West Palm Beach, Florida, United States

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Atlanta, Georgia, United States

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Chicago, Illinois, United States

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Fort Wayne, Indiana, United States

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Indianapolis, Indiana, United States

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Lexington, Kentucky, United States

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Baltimore, Maryland, United States

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Glen Burnie, Maryland, United States

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Boston, Massachusetts, United States

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West Yarmouth, Massachusetts, United States

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Ann Arbor, Michigan, United States

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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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Kenilworth, New Jersey, United States

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Morristown, New Jersey, United States

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Princeton, New Jersey, United States

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Stratford, New Jersey, United States

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Albuquerque, New Mexico, United States

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Albany, New York, United States

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Brooklyn, New York, United States

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Elmsford, New York, United States

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New York, New York, United States

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Olean, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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Durham, North Carolina, United States

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Raleigh, North Carolina, United States

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Centerville, Ohio, United States

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Columbus, Ohio, United States

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Toledo, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Jenkintown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Scotland, Pennsylvania, United States

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East Providence, Rhode Island, United States

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Beaufort, South Carolina, United States

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Charleston, South Carolina, United States

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Greer, South Carolina, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Ogden, Utah, United States

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Salt Lake City, Utah, United States

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Bennington, Vermont, United States

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Alexandria, Virginia, United States

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Charlottesville, Virginia, United States

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Virginia Beach, Virginia, United States

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Middleton, Wisconsin, United States

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Milwaukee, Wisconsin, United States

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Winnepeg, Manitoba, Canada

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Halifax, Nova Scotia, Canada

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Kingston, Ontario, Canada

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Ottawa, Ontario, Canada

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Toronto, Ontario, Canada

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Regina, Saskatchewan, Canada

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MeSH Terms

Conditions

Alzheimer DiseaseDementia

Interventions

tarenflurbil

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Mark Laughlin, MD

    Myrexis Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 21, 2006

First Posted

September 25, 2006

Study Start

September 1, 2006

Study Completion

December 1, 2008

Last Updated

August 5, 2008

Record last verified: 2008-08

Locations