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

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: Completed
• Conditions: Dementia; Alzheimer Disease
• Intervention / Treatment: Drug: MPC-7869; Drug: MPC-7869

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: Interventional
• Enrollment (Actual): 1600
• Phase: Phase 3

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Cognition and activities of daily living	18 mos

Secondary Outcome Measures

Outcome Measure	Time Frame
Global function and behavior	18 mos

Collaborators and Investigators

• Sponsor: Myrexis Inc.
• Investigators: Study Director: Ed Swabb, MD, Myrexis Inc.

Publications and helpful links

General Publications

• Green RC, Schneider LS, Amato DA, Beelen AP, Wilcock G, Swabb EA, Zavitz KH; Tarenflurbil Phase 3 Study Group. Effect of tarenflurbil on cognitive decline and activities of daily living in patients with mild Alzheimer disease: a randomized controlled trial. JAMA. 2009 Dec 16;302(23):2557-64. doi: 10.1001/jama.2009.1866.

Study record dates

Study Major Dates

• Study Start: February 1, 2005
• Study Completion (Actual): May 1, 2008

Study Registration Dates

• First Submitted: March 15, 2005
• First Submitted That Met QC Criteria: March 15, 2005
• First Posted (Estimate): March 16, 2005

Study Record Updates

• Last Update Posted (Estimate): May 5, 2009
• Last Update Submitted That Met QC Criteria: May 3, 2009
• Last Verified: May 1, 2009

More Information

Terms related to this study

• Keywords: Dementia; Alzheimer's; Dementia of Alzheimer Type
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Neurodegenerative Diseases; Tauopathies; Dementia; Alzheimer Disease; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Flurbiprofen
• Other Study ID Numbers: MPC-7869-04-005.02