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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

September 21, 2006
August 1, 2008
September 2006
Not Provided
Primary Safety [ Time Frame: For study duration ] [ Designated as safety issue: Yes ]
Primary Safety
Complete list of historical versions of study NCT00380276 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol
Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type

Open-label treatment with MPC-7869 for participants in a previous randomized study.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Alzheimer's Disease
Drug: MPC-7869
800 mg BID Oral dosing
Open Label Arm
Treatment is open-label
Intervention: Drug: MPC-7869
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1000
December 2008
Not Provided

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.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00380276
MPC-7869-05-009
Not Provided
Ed Swabb, MD, Myriad Pharmaceuticals
Myrexis Inc.
Not Provided
Study Director: Mark Laughlin, MD Myrexis Inc.
Myrexis Inc.
August 2008

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