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

Primary Purpose

Alzheimer Disease, Dementia

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
MPC-7869
MPC-7869
Sponsored by
Myrexis Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer Disease focused on measuring Alzheimer Disease, Dementia

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Oral 800 mg BID dosing

Oral BID dosing

Outcomes

Primary Outcome Measures

Cognition and activities of daily living

Secondary Outcome Measures

Global function and cognition

Full Information

First Posted
May 2, 2006
Last Updated
August 1, 2008
Sponsor
Myrexis Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00322036
Brief Title
Global Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Terminated
Why Stopped
Myriad has discontinued the development of Flurizan.
Study Start Date
May 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Myrexis Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer Disease, Dementia
Keywords
Alzheimer Disease, Dementia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Oral 800 mg BID dosing
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Oral BID dosing
Intervention Type
Drug
Intervention Name(s)
MPC-7869
Intervention Description
Oral 800 mg BID
Intervention Type
Drug
Intervention Name(s)
MPC-7869
Intervention Description
Oral BID dosing
Primary Outcome Measure Information:
Title
Cognition and activities of daily living
Time Frame
18 mos
Secondary Outcome Measure Information:
Title
Global function and cognition
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Laughlin, MD
Organizational Affiliation
Myrexis Inc.
Official's Role
Study Director
Facility Information:
City
Phoenix
State/Province
Arizona
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United States
City
Tucson
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Arizona
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United States
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Costa Mesa
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California
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United States
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San Diego
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California
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United States
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New Haven
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Connecticut
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United States
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Deerfield Beach
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Florida
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United States
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DelRay Beach
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Florida
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United States
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Gainsville
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Florida
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United States
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Hollywood
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United States
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Miami
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Tampa
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West Palm Beach
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Chicago
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Illinois
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United States
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Indianapolis
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Indiana
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United States
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Lexington
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Kentucky
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United States
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Boston
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Massachusetts
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United States
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Farmington Hills
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Michigan
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United States
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St. Louis
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Missouri
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United States
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Rochester
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New York
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United States
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Providence
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Rhode Island
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United States
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Charleston
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South Carolina
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United States
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Dallas
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Texas
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Salt Lake City
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Utah
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United States
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Aalst
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Belgium
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Antwerpen
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Belgium
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Edegem
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Belgium
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Hasselt
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Belgium
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Leuven
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Belgium
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Sint-truiden
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Belgium
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Calgary
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Alberta
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Canada
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Medicine Hat
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Alberta
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Canada
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Vancouver
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British Columbia
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Canada
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Winnipeg
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Manitoba
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Canada
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Moncton
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New Brunswick
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Canada
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Saint John
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New Brunswick
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Canada
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Halifax
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Nova Scotia
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Canada
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Kingston
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Ontario
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Canada
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London
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Ontario
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Canada
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Ottawa
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Ontario
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Canada
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Peterborough
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Ontario
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Canada
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Toronto
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Ontario
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Canada
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Greenfield Park
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Quebec
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Canada
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Montreal
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Quebec
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Canada
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Verdun
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Quebec
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Canada
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Regina
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Saskatchewan
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Canada
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Odense C
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Denmark
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Odense
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Denmark
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Bordeaux
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France
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Dijon
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France
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Marseille
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France
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Montpellier
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France
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Nice
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France
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Reims
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France
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Rennes
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France
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Saint Herblain
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France
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Toulouse
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France
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Tours
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France
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Berlin
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Germany
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Bochum
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Germany
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Bonn
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Germany
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Darmstadt
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Germany
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Dusseldorf
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Germany
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Freiburg
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Germany
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Hamburg
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Germany
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Heidelberg
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Germany
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Leipzig
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Germany
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Mannheim
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Germany
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Munchen
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Germany
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Schwerin
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Germany
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Brescia
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Italy
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Milano
Country
Italy
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Perugia
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Italy
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Pisa
Country
Italy
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Roma
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Italy
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Amsterdam
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Netherlands
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Blaricum
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Netherlands
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Hertogenbosch
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Netherlands
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Barcelona
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Spain
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Bilbao
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Spain
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Getafe. Madrid
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Spain
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Madrid
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Spain
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Lund
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Sweden
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Basel
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Switzerland
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Bath
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England
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United Kingdom
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London
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England
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United Kingdom
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Oxford
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United Kingdom
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Sheffield
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United Kingdom
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Swindon
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England
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United Kingdom
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Belfast
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N. Ireland
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United Kingdom
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Glasgow
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Scotland
Country
United Kingdom
City
Penarth
State/Province
Wales
Country
United Kingdom
City
Southhampton
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

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

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