Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
Phase 3, Multicenter, Randomized, Double Blind, Placebo Controlled Study of the Effect of Daily Treatment With MPC-7869 on Measures of Cognition, Activities of Daily Living and Global Function in Subjects With Mild Dementia of the Alzheimer's Type
1 other identifier
interventional
1,600
1 country
132
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 alzheimer-disease
Started Feb 2005
Typical duration for phase_3 alzheimer-disease
132 active sites
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
February 1, 2005
CompletedFirst Submitted
Initial submission to the registry
March 15, 2005
CompletedFirst Posted
Study publicly available on registry
March 16, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedMay 5, 2009
May 1, 2009
March 15, 2005
May 3, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognition and activities of daily living
18 mos
Secondary Outcomes (1)
Global function and behavior
18 mos
Study Arms (2)
1
EXPERIMENTAL800 mg BID
2
PLACEBO COMPARATORBID dosing
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Myrexis Inc.lead
Study Sites (132)
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Alabaster, Alabama, 35007, United States
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Huntsville, Alabama, 35801, United States
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Mesa, Arizona, 85210, United States
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Peoria, Arizona, 85381, United States
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Phoenix, Arizona, 85013, United States
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Sun City, Arizona, 85351, United States
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Tucson, Arizona, 85741-3537, United States
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Little Rock, Arkansas, 72205, United States
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Fresno, California, 93720, United States
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Irvine, California, 92697-4540, United States
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La Jolla, California, 90237, United States
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Lafayette, California, 94549, United States
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Laguna Hills, California, 92653, United States
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Long Beach, California, 90822, United States
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Los Angeles, California, 90033, United States
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Newport Beach, California, 92660, United States
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Newport Beach, California, 92663, United States
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Oceanside, California, 92056, United States
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Rancho Mirage, California, 92270, United States
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Sacramento, California, 95816, United States
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San Diego, California, 92103, United States
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San Francisco, California, 94109, United States
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San Francisco, California, 94143, United States
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Vista, California, 92083, United States
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Denver, Colorado, 80218, United States
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Danbury, Connecticut, 06810, United States
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Darien, Connecticut, 06820, United States
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New Haven, Connecticut, 06510, United States
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Washington D.C., District of Columbia, 20007, United States
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Bay Harbor, Florida, 33154, United States
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Boca Raton, Florida, 33486, United States
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Clearwater, Florida, 33761-2010, United States
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Derrfield Beach, Florida, 33064, United States
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Fort Lauderdale, Florida, 33321, United States
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Fort Myers, Florida, 33912, United States
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Fort Myers, Florida, 33916, United States
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Hialeah, Florida, 33016, United States
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Hollywood, Florida, 33021, United States
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Jacksonville, Florida, 32216, United States
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Jacksonville, Florida, 32224, United States
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Miami, Florida, 33144, United States
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Naples, Florida, 34102, United States
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North Miami, Florida, 33161, United States
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Ocala, Florida, 34471, United States
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Orlando, Florida, 32806, United States
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Plantation, Florida, 33324, United States
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Pompano Beach, Florida, 33060, United States
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Tampa, Florida, 33609, United States
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Tampa, Florida, 33613, United States
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Tampa, Florida, 33617, United States
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Tampa, Florida, 33647, United States
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West Palm Beach, Florida, 33407, United States
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Atlanta, Georgia, 30328, United States
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Decatur, Georgia, 30033, United States
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Chicago, Illinois, 60194, United States
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Fort Wayne, Indiana, 46805, United States
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Indianapolis, Indiana, 46260, United States
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Lexington, Kentucky, 40504, United States
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New Orleans, Louisiana, 70112, United States
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Baltimore, Maryland, 21285, United States
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Glen Burnie, Maryland, 21061, United States
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Boston, Massachusetts, 02118, United States
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Brockton, Massachusetts, 02301, United States
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West Yarmouth, Massachusetts, 02673, United States
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Farmington Hills, Michigan, 48334, United States
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Grand Rapids, Michigan, 49525, United States
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Rochester, Minnesota, 55901, United States
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Kansas City, Missouri, 64114, United States
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St Louis, Missouri, 63141, United States
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Lebanon, New Hampshire, 03756, United States
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Kenilworth, New Jersey, 07033, United States
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Morristown, New Jersey, 07960, United States
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Piscataway, New Jersey, 08855, United States
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Princeton, New Jersey, 08540, United States
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Stratford, New Jersey, 08084, United States
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Toms River, New Jersey, 08755, United States
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Albuquerque, New Mexico, 87102, United States
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Albany, New York, 12205, United States
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Brooklyn, New York, 11201, United States
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Brooklyn, New York, 11223, United States
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Elmsford, New York, 10523, United States
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New York, New York, 10016, United States
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New York, New York, 10021, United States
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New York, New York, 10032, United States
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Olean, New York, 14760, United States
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Rochester, New York, 14620, United States
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Syracuse, New York, 13210, United States
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Durham, North Carolina, 27710, United States
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Raleigh, North Carolina, 27607-6520, United States
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Winston-Salem, North Carolina, 27103, United States
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Centerville, Ohio, 45459, United States
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Cincinnati, Ohio, 45267, United States
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Columbus, Ohio, 43210, United States
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Toledo, Ohio, 43614, United States
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Oklahoma City, Oklahoma, 73112, United States
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Oklahoma City, Oklahoma, 73118, United States
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Oklahoma City, Oklahoma, 73120, United States
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Eugene, Oregon, 97404, United States
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Portland, Oregon, 97210, United States
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Portland, Oregon, 97239, United States
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Bala-Cynwyd, Pennsylvania, 19004, United States
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Jenkintown, Pennsylvania, 19046, United States
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Philadelphia, Pennsylvania, 19104, United States
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Philadelphia, Pennsylvania, 19107, United States
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Philadelphia, Pennsylvania, 19115, United States
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Pittsburgh, Pennsylvania, 15206, United States
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Pittsburgh, Pennsylvania, 15213, United States
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Scotland, Pennsylvania, 17254, United States
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East Providence, Rhode Island, 02914, United States
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East Providence, Rhode Island, 02916, United States
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Providence, Rhode Island, 02906, United States
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Beaufort, South Carolina, 29902, United States
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Greer, South Carolina, 29651, United States
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North Charleston, South Carolina, 29406-6076, United States
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Johnson City, Tennessee, 37601, United States
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Memphis, Tennessee, 38105, United States
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Nashville, Tennessee, 37203, United States
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Austin, Texas, 78757, United States
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Dallas, Texas, 75390, United States
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Galveston, Texas, 77555-0539, United States
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Houston, Texas, 77030, United States
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San Antonio, Texas, 78229, United States
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Wichita Falls, Texas, 76301, United States
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Ogden, Utah, 84405, United States
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Salt Lake City, Utah, 84107, United States
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Salt Lake City, Utah, 84108, United States
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Bennington, Vermont, 05201, United States
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Alexandria, Virginia, 22304, United States
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Charlottesville, Virginia, 22903, United States
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Virginia Beach, Virginia, 23452, United States
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Middleton, Wisconsin, 53562, United States
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Milwaukee, Wisconsin, 53226, United States
Related Publications (1)
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.
PMID: 20009055DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ed Swabb, MD
Myrexis Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 15, 2005
First Posted
March 16, 2005
Study Start
February 1, 2005
Study Completion
May 1, 2008
Last Updated
May 5, 2009
Record last verified: 2009-05