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
  Purpose

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 Intervention Phase
Alzheimer Disease
Dementia
Drug: MPC-7869
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Myrexis Inc.:

Primary Outcome Measures:
  • Cognition and activities of daily living [ Time Frame: 18 mos ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Global function and behavior [ Time Frame: 18 mos ] [ Designated as safety issue: No ]

Enrollment: 1600
Study Start Date: February 2005
Study Completion Date: May 2008
Arms Assigned Interventions
Experimental: 1
800 mg BID
Drug: MPC-7869
oral 800 mg BID
Placebo Comparator: 2
BID dosing
Drug: MPC-7869
Oral BID dosing

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.

  Eligibility

Ages Eligible for Study:   55 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00105547

  Hide Study Locations
Locations
United States, Alabama
Alabaster, Alabama, United States, 35007
Huntsville, Alabama, United States, 35801
United States, 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
United States, Arkansas
Little Rock, Arkansas, United States, 72205
United States, 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, 92660
Newport Beach, California, United States, 92663
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, 94109
San Francisco, California, United States, 94143
Vista, California, United States, 92083
United States, Colorado
Denver, Colorado, United States, 80218
United States, Connecticut
Danbury, Connecticut, United States, 06810
Darien, Connecticut, United States, 06820
New Haven, Connecticut, United States, 06510
United States, District of Columbia
Washington, District of Columbia, United States, 20007
United States, 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, 33617
Tampa, Florida, United States, 33613
Tampa, Florida, United States, 33647
Tampa, Florida, United States, 33609
West Palm Beach, Florida, United States, 33407
United States, Georgia
Atlanta, Georgia, United States, 30328
Decatur, Georgia, United States, 30033
United States, Illinois
Chicago, Illinois, United States, 60194
United States, Indiana
Ft. Wayne, Indiana, United States, 46805
Indianapolis, Indiana, United States, 46260
United States, Kentucky
Lexington, Kentucky, United States, 40504
United States, Louisiana
New Orleans, Louisiana, United States, 70112
United States, Maryland
Baltimore,, Maryland, United States, 21285
Glen Burnie, Maryland, United States, 21061
United States, Massachusetts
Boston, Massachusetts, United States, 02118
Brockton, Massachusetts, United States, 02301
West Yarmouth, Massachusetts, United States, 02673
United States, Michigan
Farmington Hills, Michigan, United States, 48334
Grand Rapids, Michigan, United States, 49525
United States, Minnesota
Rochester, Minnesota, United States, 55901
United States, Missouri
Kansas City, Missouri, United States, 64114
St. Louis, Missouri, United States, 63141
United States, New Hampshire
Lebanon, New Hampshire, United States, 03756
United States, 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
United States, New Mexico
Albuquerque, New Mexico, United States, 87102
United States, 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, 10032
New York, New York, United States, 10016
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
United States, North Carolina
Durham, North Carolina, United States, 27710
Raleigh, North Carolina, United States, 27607-6520
Winston-Salem, North Carolina, United States, 27103
United States, Ohio
Centerville, Ohio, United States, 45459
Cincinnati, Ohio, United States, 45267
Columbus, Ohio, United States, 43210
Toledo, Ohio, United States, 43614
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73118
Oklahoma City, Oklahoma, United States, 73120
Oklahoma City, Oklahoma, United States, 73112
United States, Oregon
Eugene, Oregon, United States, 97404
Portland, Oregon, United States, 97210
Portland, Oregon, United States, 97239
United States, Pennsylvania
Bala Cynwyd, Pennsylvania, United States, 19004
Jenkintown, Pennsylvania, United States, 19046
Philadelphia, Pennsylvania, United States, 19107
Philadelphia, Pennsylvania, United States, 19115
Philadelphia, Pennsylvania, United States, 19104
Pittsburg, Pennsylvania, United States, 15213
Pittsburgh, Pennsylvania, United States, 15206
Pittsburgh, Pennsylvania, United States, 15213
Scotland, Pennsylvania, United States, 17254
United States, Rhode Island
East Providence, Rhode Island, United States, 02914
East Providence, Rhode Island, United States, 02916
Providence, Rhode Island, United States, 02906
United States, South Carolina
Beaufort, South Carolina, United States, 29902
Greer, South Carolina, United States, 29651
North Charleston, South Carolina, United States, 29406-6076
United States, Tennessee
Johnson City, Tennessee, United States, 37601
Memphis, Tennessee, United States, 38105
Nashville, Tennessee, United States, 37203
United States, 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
United States, Utah
Ogden, Utah, United States, 84405
Salt Lake City, Utah, United States, 84108
Salt Lake City, Utah, United States, 84107
United States, Vermont
Bennington, Vermont, United States, 05201
United States, Virginia
Alexandria, Virginia, United States, 22304
Charlottesville, Virginia, United States, 22903
Virginia Beach, Virginia, United States, 23452
United States, Wisconsin
Middleton, Wisconsin, United States, 53562
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Myrexis Inc.
Investigators
Study Director: Ed Swabb, MD Myrexis Inc.
  More Information

No publications provided by Myrexis Inc.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ed Swabb, MD, Myriad Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00105547     History of Changes
Other Study ID Numbers: MPC-7869-04-005.02
Study First Received: March 15, 2005
Last Updated: May 3, 2009
Health Authority: United States: Food and Drug Administration

Keywords provided by Myrexis Inc.:
Alzheimer's
Dementia
Dementia of Alzheimer Type

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 15, 2014