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

This study has been terminated.

(Myriad has discontinued the development of Flurizan.)

Sponsor:

Information provided by:

Myrexis Inc.

ClinicalTrials.gov Identifier:

NCT00380276

First received: September 21, 2006

Last updated: August 1, 2008

Last verified: August 2008

History of Changes

Tracking Information

First Received Date ^ICMJE

September 21, 2006

Last Updated Date

August 1, 2008

Start Date ^ICMJE

September 2006

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Primary Safety [ Time Frame: For study duration ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Primary Safety

Change History

Complete list of historical versions of study NCT00380276 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type

Brief Summary

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

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Alzheimer's Disease

Intervention ^ICMJE

Drug: MPC-7869

800 mg BID Oral dosing

Study Arm (s)

Open Label Arm

Treatment is open-label

Intervention: Drug: MPC-7869

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

1000

Estimated Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

55 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT Number ^ICMJE

NCT00380276

Other Study ID Numbers ^ICMJE

MPC-7869-05-009

Has Data Monitoring Committee

Responsible Party

Ed Swabb, MD, Myriad Pharmaceuticals

Study Sponsor ^ICMJE

Myrexis Inc.

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

Mark Laughlin, MD

Myrexis Inc.

Information Provided By

Myrexis Inc.

Verification Date

August 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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