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

NCT ID: NCT00322036

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

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-31

Study Completion Date

2008-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Alzheimer Disease Dementia

Keywords

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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

Oral 800 mg BID dosing

Group Type EXPERIMENTAL

MPC-7869

Intervention Type DRUG

Oral 800 mg BID

2

Oral 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

1. Have had a diagnosis of probable Alzheimer's disease
2. 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).
3. Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
4. 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.
5. At least 6 years of education, or sufficient work history to exclude mental retardation.
6. Female subjects must be surgically sterile or postmenopausal for \> 1 year.
7. Adequate vision and hearing to participate in study assessments.
8. Subjects must have a reliable caregiver who can read, understand and speak same language.

Exclusion Criteria

1. Current evidence of other causes of dementia.. .
2. 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.
3. Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.
4. Major surgery and related complications not resolved within 12 weeks prior to Day 1.
5. Previous participation in an MPC-7869 clinical study.
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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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

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Countries

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United States Belgium Canada Denmark France Germany Italy Netherlands Spain Sweden Switzerland United Kingdom

Other Identifiers

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MPC-7869-05-010.01

Identifier Type: -

Identifier Source: org_study_id