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Trial record 1 of 1 for:    NCT00105547
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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: NCT00105547
Recruitment Status : Completed
First Posted : March 16, 2005
Last Update Posted : May 5, 2009
Information provided by:
Myrexis Inc.

Brief Summary:
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.

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

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : February 2005
Actual Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

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

Placebo Comparator: 2
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 behavior [ Time Frame: 18 mos ]

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:

  • 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.

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): NCT00105547

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Sponsors and Collaborators
Myrexis Inc.
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Study Director: Ed Swabb, MD Myrexis Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Ed Swabb, MD, Myriad Pharmaceuticals Identifier: NCT00105547    
Other Study ID Numbers: MPC-7869-04-005.02
First Posted: March 16, 2005    Key Record Dates
Last Update Posted: May 5, 2009
Last Verified: May 2009
Keywords provided by Myrexis Inc.:
Dementia of Alzheimer Type
Additional relevant MeSH terms:
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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