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

This study has been completed.
Sponsor:
Information provided by:
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00105547
First received: March 15, 2005
Last updated: May 3, 2009
Last verified: May 2009

March 15, 2005
May 3, 2009
February 2005
Not Provided
Cognition and activities of daily living [ Time Frame: 18 mos ] [ Designated as safety issue: No ]
Cognition and activities of daily living
Complete list of historical versions of study NCT00105547 on ClinicalTrials.gov Archive Site
Global function and behavior [ Time Frame: 18 mos ] [ Designated as safety issue: No ]
Global function and behavior
Not Provided
Not Provided
 
Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
Phase 3, Multicenter, 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

The purpose of the study is to evaluate the change in cognitive ability and activities of daily living in patients with Alzheimer's disease (AD) as measured by specific evaluations during 18 months of dosing.

This trial is a phase 3, multicenter, randomized, double-blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of MPC-7869 to placebo. The 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.

The primary objective of the study is to evaluate the change in cognition and activities of daily living.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Dementia
  • Drug: MPC-7869
    oral 800 mg BID
  • Drug: MPC-7869
    Oral BID dosing
  • Experimental: 1
    800 mg BID
    Intervention: Drug: MPC-7869
  • Placebo Comparator: 2
    BID dosing
    Intervention: Drug: MPC-7869
Green RC, Schneider LS, Amato DA, Beelen AP, Wilcock G, Swabb EA, Zavitz KH; Tarenflurbil Phase 3 Study Group. Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease: a randomized controlled trial. JAMA. 2009 Dec 16;302(23):2557-64. doi: 10.1001/jama.2009.1866.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1600
May 2008
Not Provided

Inclusion Criteria:

  • 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.
  • Ability to read and understand English or Spanish to ensure compliance with cognitive testing and study visit procedures.
  • Female subjects must be surgically sterile or postmenopausal for > 1 year.
  • Subjects currently taking approved medication for Alzheimer's disease for at least six months prior to day 1 may be enrolled.
  • Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.

Exclusion Criteria:

  • Current evidence of other causes of dementia.
  • 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.
  • Major surgery and related complications not resolved within 12 weeks prior to Day 1.
Both
55 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00105547
MPC-7869-04-005.02
Yes
Ed Swabb, MD, Myriad Pharmaceuticals
Myrexis Inc.
Not Provided
Study Director: Ed Swabb, MD Myrexis Inc.
Myrexis Inc.
May 2009

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