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

NCT ID: NCT00380276

Last Updated: 2008-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

1000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2008-12-31

Brief Summary

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

Detailed Description

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Conditions

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Alzheimer's Disease

Keywords

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Alzheimer's Dementia Dementia of Alzheimer Type

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Open Label Arm

Treatment is open-label

Group Type OTHER

MPC-7869

Intervention Type DRUG

800 mg BID Oral dosing

Interventions

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MPC-7869

800 mg BID Oral dosing

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Myrexis Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Myriad Pharmaceuticals

Principal Investigators

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Mark Laughlin, MD

Role: STUDY_DIRECTOR

Myrexis Inc.

Locations

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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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Countries

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United States Canada

Other Identifiers

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MPC-7869-05-009

Identifier Type: -

Identifier Source: org_study_id