Trial record 2 of 5 for:    flurizan

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
  Purpose

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


Condition Intervention Phase
Alzheimer's Disease
Drug: MPC-7869
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type

Resource links provided by NLM:


Further study details as provided by Myrexis Inc.:

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

Estimated Enrollment: 1000
Study Start Date: September 2006
Estimated Study Completion Date: December 2008
Arms Assigned Interventions
Open Label Arm
Treatment is open-label
Drug: MPC-7869
800 mg BID Oral dosing

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380276

  Show 90 Study Locations
Sponsors and Collaborators
Myrexis Inc.
Investigators
Study Director: Mark Laughlin, MD Myrexis Inc.
  More Information

No publications provided

Responsible Party: Ed Swabb, MD, Myriad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00380276     History of Changes
Other Study ID Numbers: MPC-7869-05-009
Study First Received: September 21, 2006
Last Updated: August 1, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:
Alzheimer's
Dementia
Dementia of Alzheimer Type

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 28, 2014