Study Stopped
Myriad has discontinued the development of Flurizan.
Global Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
Phase 3 Multinational, 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
800
12 countries
92
Brief Summary
This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 alzheimer-disease
Started May 2006
92 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
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 2, 2006
CompletedFirst Posted
Study publicly available on registry
May 4, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2008
CompletedAugust 5, 2008
August 1, 2008
May 2, 2006
August 1, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cognition and activities of daily living
18 mos
Secondary Outcomes (1)
Global function and cognition
18 months
Study Arms (2)
1
EXPERIMENTALOral 800 mg BID dosing
2
PLACEBO COMPARATOROral BID dosing
Interventions
Eligibility Criteria
You may qualify if:
- Have had a diagnosis of probable Alzheimer's disease
- Men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
- Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
- Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures.
- At least 6 years of education, or sufficient work history to exclude mental retardation.
- Female subjects must be surgically sterile or postmenopausal for \> 1 year.
- Adequate vision and hearing to participate in study assessments.
- Subjects must have a reliable caregiver who can read, understand and speak same language.
You may not qualify if:
- Current evidence of other causes of dementia.. .
- History of, 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.
- 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.
- Previous participation in an MPC-7869 clinical study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Myrexis Inc.lead
Study Sites (92)
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Phoenix, Arizona, United States
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Tucson, Arizona, United States
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Costa Mesa, California, United States
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San Diego, California, United States
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New Haven, Connecticut, United States
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Deerfield Beach, Florida, United States
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Delray Beach, Florida, United States
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Gainsville, Florida, United States
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Hollywood, Florida, United States
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Miami, 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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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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Lexington, Kentucky, United States
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Boston, Massachusetts, United States
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Farmington Hills, Michigan, United States
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St Louis, Missouri, United States
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Rochester, New York, United States
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Providence, Rhode Island, United States
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Charleston, South Carolina, United States
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Dallas, Texas, United States
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Salt Lake City, Utah, United States
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Aalst, Belgium
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Antwerp, Belgium
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Edegem, Belgium
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Hasselt, Belgium
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Leuven, Belgium
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Sint-Truiden, Belgium
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Calgary, Alberta, Canada
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Medicine Hat, Alberta, Canada
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Vancouver, British Columbia, Canada
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Winnipeg, Manitoba, Canada
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Moncton, New Brunswick, Canada
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Saint John, New Brunswick, Canada
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Halifax, Nova Scotia, Canada
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Kingston, Ontario, Canada
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London, Ontario, Canada
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Ottawa, Ontario, Canada
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Peterborough, Ontario, Canada
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Toronto, Ontario, Canada
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Greenfield Park, Quebec, Canada
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Montreal, Quebec, Canada
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Verdun, Quebec, Canada
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Regina, Saskatchewan, Canada
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Odense, Denmark
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Odense C, Denmark
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Bordeaux, France
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Dijon, France
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Marseille, France
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Montpellier, France
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Nice, France
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Reims, France
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Rennes, France
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Saint-Herblain, France
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Toulouse, France
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Tours, France
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Berlin, Germany
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Bochum, Germany
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Bonn, Germany
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Darmstadt, Germany
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Düsseldorf, Germany
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Freiburg im Breisgau, Germany
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Hamburg, Germany
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Heidelberg, Germany
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Leipzig, Germany
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Mannheim, Germany
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München, Germany
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Schwerin, Germany
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Brescia, Italy
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Milan, Italy
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Perugia, Italy
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Pisa, Italy
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Roma, Italy
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's-Hertogenbosch, Netherlands
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Amsterdam, Netherlands
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Blaricum, Netherlands
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Barcelona, Spain
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Bilbao, Spain
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Getafe. Madrid, Spain
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Madrid, Spain
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Lund, Sweden
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Basel, Switzerland
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Bath, England, United Kingdom
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London, England, United Kingdom
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Oxford, England, United Kingdom
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Sheffield, England, United Kingdom
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Swindon, England, United Kingdom
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Belfast, Northern Ireland, United Kingdom
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Glasgow, Scotland, United Kingdom
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Penarth, Wales, United Kingdom
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Southhampton, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Mark Laughlin, 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
May 2, 2006
First Posted
May 4, 2006
Study Start
May 1, 2006
Study Completion
December 1, 2008
Last Updated
August 5, 2008
Record last verified: 2008-08