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

May 3, 2009 updated by: Myrexis Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1600

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Alabaster, Alabama, United States, 35007
      • Huntsville, Alabama, United States, 35801
    • Arizona
      • Mesa, Arizona, United States, 85210
      • Peoria, Arizona, United States, 85381
      • Phoenix, Arizona, United States, 85013
      • Sun City, Arizona, United States, 85351
      • Tucson, Arizona, United States, 85741-3537
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
    • California
      • Fresno, California, United States, 93720
      • Irvine, California, United States, 92697-4540
      • La Jolla, California, United States, 90237
      • Lafayette, California, United States, 94549
      • Laguna Hills, California, United States, 92653
      • Long Beach, California, United States, 90822
      • Los Angeles, California, United States, 90033
      • Newport Beach, California, United States, 92663
      • Newport Beach, California, United States, 92660
      • Oceanside, California, United States, 92056
      • Rancho Mirage, California, United States, 92270
      • Sacramento, California, United States, 95816
      • San Diego, California, United States, 92103
      • San Francisco, California, United States, 94143
      • San Francisco, California, United States, 94109
      • Vista, California, United States, 92083
    • Colorado
      • Denver, Colorado, United States, 80218
    • Connecticut
      • Danbury, Connecticut, United States, 06810
      • Darien, Connecticut, United States, 06820
      • New Haven, Connecticut, United States, 06510
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
    • Florida
      • Bay Harbor, Florida, United States, 33154
      • Boca Raton, Florida, United States, 33486
      • Clearwater, Florida, United States, 33761-2010
      • Derrfield Beach, Florida, United States, 33064
      • Fort Myers, Florida, United States, 33916
      • Ft. Lauderdale, Florida, United States, 33321
      • Ft. Myers, Florida, United States, 33912
      • Hialeah, Florida, United States, 33016
      • Hollywood, Florida, United States, 33021
      • Jacksonville, Florida, United States, 32224
      • Jacksonville, Florida, United States, 32216
      • Miami, Florida, United States, 33144
      • Naples, Florida, United States, 34102
      • North Miami, Florida, United States, 33161
      • Ocala, Florida, United States, 34471
      • Orlando, Florida, United States, 32806
      • Plantation, Florida, United States, 33324
      • Pompano Beach, Florida, United States, 33060
      • Tampa, Florida, United States, 33613
      • Tampa, Florida, United States, 33609
      • Tampa, Florida, United States, 33647
      • Tampa, Florida, United States, 33617
      • West Palm Beach, Florida, United States, 33407
    • Georgia
      • Atlanta, Georgia, United States, 30328
      • Decatur, Georgia, United States, 30033
    • Illinois
      • Chicago, Illinois, United States, 60194
    • Indiana
      • Ft. Wayne, Indiana, United States, 46805
      • Indianapolis, Indiana, United States, 46260
    • Kentucky
      • Lexington, Kentucky, United States, 40504
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
    • Maryland
      • Baltimore,, Maryland, United States, 21285
      • Glen Burnie, Maryland, United States, 21061
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
      • Brockton, Massachusetts, United States, 02301
      • West Yarmouth, Massachusetts, United States, 02673
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
      • Grand Rapids, Michigan, United States, 49525
    • Minnesota
      • Rochester, Minnesota, United States, 55901
    • Missouri
      • Kansas City, Missouri, United States, 64114
      • St. Louis, Missouri, United States, 63141
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
    • New Jersey
      • Kenilworth, New Jersey, United States, 07033
      • Morristown, New Jersey, United States, 07960
      • Piscataway, New Jersey, United States, 08855
      • Princeton, New Jersey, United States, 08540
      • Stratford, New Jersey, United States, 08084
      • Toms River, New Jersey, United States, 08755
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
    • New York
      • Albany, New York, United States, 12205
      • Brooklyn, New York, United States, 11201
      • Brooklyn, New York, United States, 11223
      • Elmsford, New York, United States, 10523
      • New York, New York, United States, 10016
      • New York, New York, United States, 10032
      • New York, New York, United States, 10021
      • Olean, New York, United States, 14760
      • Rochester, New York, United States, 14620
      • Syracuse, New York, United States, 13210
    • North Carolina
      • Durham, North Carolina, United States, 27710
      • Raleigh, North Carolina, United States, 27607-6520
      • Winston-Salem, North Carolina, United States, 27103
    • Ohio
      • Centerville, Ohio, United States, 45459
      • Cincinnati, Ohio, United States, 45267
      • Columbus, Ohio, United States, 43210
      • Toledo, Ohio, United States, 43614
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
      • Oklahoma City, Oklahoma, United States, 73120
      • Oklahoma City, Oklahoma, United States, 73118
    • Oregon
      • Eugene, Oregon, United States, 97404
      • Portland, Oregon, United States, 97239
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Bala Cynwyd, Pennsylvania, United States, 19004
      • Jenkintown, Pennsylvania, United States, 19046
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
      • Philadelphia, Pennsylvania, United States, 19115
      • Pittsburg, Pennsylvania, United States, 15213
      • Pittsburgh, Pennsylvania, United States, 15206
      • Pittsburgh, Pennsylvania, United States, 15213
      • Scotland, Pennsylvania, United States, 17254
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
      • East Providence, Rhode Island, United States, 02916
      • Providence, Rhode Island, United States, 02906
    • South Carolina
      • Beaufort, South Carolina, United States, 29902
      • Greer, South Carolina, United States, 29651
      • North Charleston, South Carolina, United States, 29406-6076
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
      • Memphis, Tennessee, United States, 38105
      • Nashville, Tennessee, United States, 37203
    • Texas
      • Austin, Texas, United States, 78757
      • Dallas, Texas, United States, 75390
      • Galveston, Texas, United States, 77555-0539
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
      • Wichita Falls, Texas, United States, 76301
    • Utah
      • Ogden, Utah, United States, 84405
      • Salt Lake City, Utah, United States, 84107
      • Salt Lake City, Utah, United States, 84108
    • Vermont
      • Bennington, Vermont, United States, 05201
    • Virginia
      • Alexandria, Virginia, United States, 22304
      • Charlottesville, Virginia, United States, 22903
      • Virginia Beach, Virginia, United States, 23452
    • Wisconsin
      • Middleton, Wisconsin, United States, 53562
      • Milwaukee, Wisconsin, United States, 53226

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

55 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1
800 mg BID
Drug: MPC-7869
Oral BID dosing
Drug: MPC-7869
oral 800 mg BID
Placebo Comparator: 2
BID dosing
Drug: MPC-7869
Oral BID dosing
Drug: MPC-7869
oral 800 mg BID

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Cognition and activities of daily living
Time Frame: 18 mos
18 mos

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Global function and behavior
Time Frame: 18 mos
18 mos

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Myrexis Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Ed Swabb, MD, Myrexis Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2005

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 15, 2005

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 15, 2005

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 16, 2005

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 5, 2009

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 3, 2009

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MPC-7869-04-005.02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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