Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's

NCT ID: NCT00105547

Last Updated: 2009-05-05

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

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-02-28

Study Completion Date

2008-05-31

Brief Summary

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The purpose of the study is to evaluate the change in cognitive ability and activities of daily living in patients with Alzheimer's disease (AD) as measured by specific evaluations during 18 months of dosing.

Detailed Description

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This trial is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of MPC-7869 to placebo. The study subjects will have the diagnosis of mild dementia of the Alzheimer's type. Subjects may be taking approved medication for Alzheimer's disease provided the dose has been stable for at least 6 months.

The primary objective of the study is to evaluate the change in cognition and activities of daily living.

Conditions

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Alzheimer Disease Dementia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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1

800 mg BID

Group Type EXPERIMENTAL

MPC-7869

Intervention Type DRUG

oral 800 mg BID

2

BID dosing

Group Type PLACEBO_COMPARATOR

MPC-7869

Intervention Type DRUG

Oral BID dosing

Interventions

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MPC-7869

oral 800 mg BID

Intervention Type DRUG

MPC-7869

Oral BID dosing

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 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.
* Ability to read and understand English or Spanish to ensure compliance with cognitive testing and study visit procedures.
* Female subjects must be surgically sterile or postmenopausal for \> 1 year.
* Subjects currently taking approved medication for Alzheimer's disease for at least six months prior to day 1 may be enrolled.
* Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria

* Current evidence of other causes of dementia.
* 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.
* Major surgery and related complications not resolved within 12 weeks prior to Day 1.
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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Ed Swabb, 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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Mesa, Arizona, United States

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Peoria, Arizona, 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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Little Rock, Arkansas, United States

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Fresno, California, United States

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Irvine, California, United States

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La Jolla, 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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Los Angeles, California, United States

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Newport Beach, California, United States

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Newport Beach, California, United States

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Oceanside, 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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San Francisco, California, United States

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Vista, California, United States

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Denver, Colorado, 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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Bay Harbor, Florida, United States

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Boca Raton, Florida, United States

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Clearwater, Florida, United States

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Derrfield Beach, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Myers, Florida, United States

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Fort Myers, Florida, United States

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Hialeah, Florida, United States

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Hollywood, Florida, United States

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Jacksonville, 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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North Miami, Florida, United States

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Ocala, Florida, United States

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Orlando, Florida, United States

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Plantation, Florida, United States

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Pompano Beach, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Tampa, 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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Decatur, 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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New Orleans, Louisiana, 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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Brockton, Massachusetts, United States

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West Yarmouth, Massachusetts, United States

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Farmington Hills, Michigan, United States

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Grand Rapids, Michigan, United States

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Rochester, Minnesota, United States

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Kansas City, Missouri, 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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Piscataway, 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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Toms River, 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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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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New York, 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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Winston-Salem, North Carolina, United States

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Centerville, Ohio, United States

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Cincinnati, 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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Oklahoma City, Oklahoma, 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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Portland, Oregon, United States

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Bala-Cynwyd, Pennsylvania, United States

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Jenkintown, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, 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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East Providence, Rhode Island, United States

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Providence, Rhode Island, United States

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Beaufort, South Carolina, United States

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Greer, South Carolina, United States

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North Charleston, South Carolina, United States

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Johnson City, Tennessee, United States

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Memphis, Tennessee, United States

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Nashville, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Galveston, Texas, United States

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Houston, Texas, United States

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San Antonio, Texas, United States

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Wichita Falls, 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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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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Countries

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United States

References

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Green RC, Schneider LS, Amato DA, Beelen AP, Wilcock G, Swabb EA, Zavitz KH; Tarenflurbil Phase 3 Study Group. Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease: a randomized controlled trial. JAMA. 2009 Dec 16;302(23):2557-64. doi: 10.1001/jama.2009.1866.

Reference Type DERIVED
PMID: 20009055 (View on PubMed)

Other Identifiers

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MPC-7869-04-005.02

Identifier Type: -

Identifier Source: org_study_id

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