Trial record 3 of 5 for:    flurizan

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00322036
Recruitment Status : Terminated (Myriad has discontinued the development of Flurizan.)
First Posted : May 4, 2006
Last Update Posted : August 5, 2008
Information provided by:
Myrexis Inc.

May 2, 2006
May 4, 2006
August 5, 2008
May 2006
Not Provided
Cognition and activities of daily living [ Time Frame: 18 mos ]
Cognition and activities of daily living
Complete list of historical versions of study NCT00322036 on Archive Site
Global function and cognition [ Time Frame: 18 months ]
Global function and cognition
Not Provided
Not Provided
Global Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
Phase 3 Multinational, 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
This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. 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.
Not Provided
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
  • Alzheimer Disease
  • Dementia
  • Drug: MPC-7869
    Oral 800 mg BID
  • Drug: MPC-7869
    Oral BID dosing
  • Experimental: 1
    Oral 800 mg BID dosing
    Intervention: Drug: MPC-7869
  • Placebo Comparator: 2
    Oral BID dosing
    Intervention: Drug: MPC-7869
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
December 2008
Not Provided

Inclusion Criteria:

  1. Have had a diagnosis of probable Alzheimer's disease
  2. Men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
  3. Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
  4. Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures.
  5. At least 6 years of education, or sufficient work history to exclude mental retardation.
  6. Female subjects must be surgically sterile or postmenopausal for > 1 year.
  7. Adequate vision and hearing to participate in study assessments.
  8. Subjects must have a reliable caregiver who can read, understand and speak same language.

Exclusion Criteria:

  1. Current evidence of other causes of dementia.. .
  2. History of, 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.
  3. Use of any investigational therapy within 30 days, or 5 half-lives, whichever is longer, and/or use of AD immunotherapy prior to screening.
  4. Major surgery and related complications not resolved within 12 weeks prior to Day 1.
  5. Previous participation in an MPC-7869 clinical study.
Sexes Eligible for Study: All
55 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Denmark,   France,   Germany,   Italy,   Netherlands,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Not Provided
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