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.

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alzheimer Disease Dementia Drug: MPC-7869 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2006
Estimated Study Completion Date : December 2008

Arm Intervention/treatment
Experimental: 1
Oral 800 mg BID dosing
Drug: MPC-7869
Oral 800 mg BID

Placebo Comparator: 2
Oral BID dosing
Drug: MPC-7869
Oral BID dosing

Primary Outcome Measures :
  1. Cognition and activities of daily living [ Time Frame: 18 mos ]

Secondary Outcome Measures :
  1. Global function and cognition [ Time Frame: 18 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   55 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00322036

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United States, Arizona
Phoenix, Arizona, United States
Tucson, Arizona, United States
United States, California
Costa Mesa, California, United States
San Diego, California, United States
United States, Connecticut
New Haven, Connecticut, United States
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Sheffield, England, United Kingdom
Swindon, England, United Kingdom
Belfast, N. Ireland, United Kingdom
Glasgow, Scotland, United Kingdom
Penarth, Wales, United Kingdom
Southhampton, United Kingdom
Sponsors and Collaborators
Myrexis Inc.
Study Director: Mark Laughlin, MD Myrexis Inc.

Responsible Party: Ed Swabb, MD, Myriad Pharmaceuticals Identifier: NCT00322036     History of Changes
Other Study ID Numbers: MPC-7869-05-010.01
First Posted: May 4, 2006    Key Record Dates
Last Update Posted: August 5, 2008
Last Verified: August 2008

Keywords provided by Myrexis Inc.:
Alzheimer Disease

Additional relevant MeSH terms:
Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action