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Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol

Primary Purpose

Alzheimer's Disease

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

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring Alzheimer's, Dementia, Dementia of Alzheimer Type

Eligibility Criteria

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

Inclusion Criteria:

  • Participation in a previous MPC-7869 randomized protocol
  • 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.
  • Female subjects must be surgically sterile or postmenopausal for > 1 year.
  • Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria:

  • 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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Open Label Arm

Arm Description

Treatment is open-label

Outcomes

Primary Outcome Measures

Primary Safety

Secondary Outcome Measures

Full Information

First Posted
September 21, 2006
Last Updated
August 1, 2008
Sponsor
Myrexis Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00380276
Brief Title
Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol
Official Title
Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With 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
September 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Myrexis Inc.

4. Oversight

5. Study Description

Brief Summary
Open-label treatment with MPC-7869 for participants in a previous randomized study.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open Label Arm
Arm Type
Other
Arm Description
Treatment is open-label
Intervention Type
Drug
Intervention Name(s)
MPC-7869
Intervention Description
800 mg BID Oral dosing
Primary Outcome Measure Information:
Title
Primary Safety
Time Frame
For study duration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participation in a previous MPC-7869 randomized protocol 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. Female subjects must be surgically sterile or postmenopausal for > 1 year. Subjects must have a reliable caregiver who can read, understand and speak English or Spanish. Exclusion Criteria: 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.
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
Alabaster
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Alabama
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Huntsville
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Phoenix
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Sun City
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Tucson
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Costa Mesa
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Irvine
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Lafayette
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Laguna Hills
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Long Beach
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Rancho Mirage
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San Francisco
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Vista
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Danbury
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Darien
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New Haven
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Washington D.C
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Deerfield Beach
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Fort Myers
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Ft Meyers
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Hollywood
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Jacksonville
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Miami
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Naples
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Elmsford
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Olean
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Rochester
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Syracuse
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Durham
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Raleigh
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Centerville
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Columbus
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Toledo
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Portland
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Scotland
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Beaufort
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Charleston
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Greer
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Memphis
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Nashville
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Dallas
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Houston
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San Antonio
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Ogden
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Salt Lake City
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Bennington
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Vermont
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Alexandria
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Charlottesville
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Virginia Beach
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Middleton
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Milwaukee
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Toronto
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Regina
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Canada

12. IPD Sharing Statement

Learn more about this trial

Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol

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