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CompletedNCT00105547Updated May 5, 2009

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

A Phase 3 interventional study of MPC-7869 and MPC-7869 in Alzheimer Disease and Dementia, sponsored by Myrexis Inc.. Completed at 133 sites in United States. Open to participants aged 55 Years and older. Per ClinicalTrials.gov, last updated 2009-05-05.

Sponsored by Myrexis Inc. · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,600
Allocation
Randomized
Ages
55 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Alzheimer Disease
  • Dementia

Keywords

  • Alzheimer's
  • Dementia
  • Dementia of Alzheimer Type
03

In context

Alzheimer Disease

3,675 studies on the registry are indexed under Alzheimer Disease; 869 are open to participants now.

This study's enrollment of 1,600 is above the median of 70 across 2,805 interventional studies indexed under Alzheimer Disease.

Browse Alzheimer Disease studies →

Lead sponsor

Myrexis Inc. is the lead sponsor of 15 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
55 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
1,600 participants (actual)

Study arms

  • Experimental
    1

    800 mg BID

    Drug: MPC-7869

  • Placebo comparator
    2

    BID dosing

    Drug: MPC-7869

Interventions

  • DrugMPC-7869

    oral 800 mg BID

  • DrugMPC-7869

    Oral BID dosing

06

What researchers measure

Primary outcomes

  1. Cognition and activities of daily living

    Time frame: 18 mos

Secondary outcomes

  1. Global function and behavior

    Time frame: 18 mos

07

Study locations

133 sites
  • Alabaster, Alabama 35007, United States
  • Huntsville, Alabama 35801, United States
  • Mesa, Arizona 85210, United States
  • Peoria, Arizona 85381, United States
  • Phoenix, Arizona 85013, United States
  • Sun City, Arizona 85351, United States
  • Tucson, Arizona 85741-3537, United States
  • Little Rock, Arkansas 72205, United States
  • Fresno, California 93720, United States
  • Irvine, California 92697-4540, United States
  • La Jolla, California 90237, United States
  • Lafayette, California 94549, United States
  • Laguna Hills, California 92653, United States
  • Long Beach, California 90822, United States
  • Los Angeles, California 90033, United States
  • Newport Beach, California 92660, United States
  • Newport Beach, California 92663, United States
  • Oceanside, California 92056, United States
  • Rancho Mirage, California 92270, United States
  • Sacramento, California 95816, United States
  • San Diego, California 92103, United States
  • San Francisco, California 94109, United States
  • San Francisco, California 94143, United States
  • Vista, California 92083, United States
  • Denver, Colorado 80218, United States
  • Danbury, Connecticut 06810, United States
  • Darien, Connecticut 06820, United States
  • New Haven, Connecticut 06510, United States
  • Washington, District of Columbia 20007, United States
  • Bay Harbor, Florida 33154, United States
  • Boca Raton, Florida 33486, United States
  • Clearwater, Florida 33761-2010, United States
  • Derrfield Beach, Florida 33064, United States
  • Fort Myers, Florida 33916, United States
  • Ft. Lauderdale, Florida 33321, United States
  • Ft. Myers, Florida 33912, United States
  • Hialeah, Florida 33016, United States
  • Hollywood, Florida 33021, United States
  • Jacksonville, Florida 32216, United States
  • Jacksonville, Florida 32224, United States
  • Miami, Florida 33144, United States
  • Naples, Florida 34102, United States
  • North Miami, Florida 33161, United States
  • Ocala, Florida 34471, United States
  • Orlando, Florida 32806, United States
  • Plantation, Florida 33324, United States
  • Pompano Beach, Florida 33060, United States
  • Tampa, Florida 33609, United States
  • Tampa, Florida 33613, United States
  • Tampa, Florida 33617, United States
  • Tampa, Florida 33647, United States
  • West Palm Beach, Florida 33407, United States
  • Atlanta, Georgia 30328, United States
  • Decatur, Georgia 30033, United States
  • Chicago, Illinois 60194, United States
  • Ft. Wayne, Indiana 46805, United States
  • Indianapolis, Indiana 46260, United States
  • Lexington, Kentucky 40504, United States
  • New Orleans, Louisiana 70112, United States
  • Baltimore,, Maryland 21285, United States
  • Glen Burnie, Maryland 21061, United States
  • Boston, Massachusetts 02118, United States
  • Brockton, Massachusetts 02301, United States
  • West Yarmouth, Massachusetts 02673, United States
  • Farmington Hills, Michigan 48334, United States
  • Grand Rapids, Michigan 49525, United States
  • Rochester, Minnesota 55901, United States
  • Kansas City, Missouri 64114, United States
  • St. Louis, Missouri 63141, United States
  • Lebanon, New Hampshire 03756, United States
  • Kenilworth, New Jersey 07033, United States
  • Morristown, New Jersey 07960, United States
  • Piscataway, New Jersey 08855, United States
  • Princeton, New Jersey 08540, United States
  • Stratford, New Jersey 08084, United States
  • Toms River, New Jersey 08755, United States
  • Albuquerque, New Mexico 87102, United States
  • Albany, New York 12205, United States
  • Brooklyn, New York 11201, United States
  • Brooklyn, New York 11223, United States
  • Elmsford, New York 10523, United States
  • New York, New York 10016, United States
  • New York, New York 10021, United States
  • New York, New York 10032, United States
  • Olean, New York 14760, United States
  • Rochester, New York 14620, United States
  • Syracuse, New York 13210, United States
  • Durham, North Carolina 27710, United States
  • Raleigh, North Carolina 27607-6520, United States
  • Winston-Salem, North Carolina 27103, United States
  • Centerville, Ohio 45459, United States
  • Cincinnati, Ohio 45267, United States
  • Columbus, Ohio 43210, United States
  • Toledo, Ohio 43614, United States
  • Oklahoma City, Oklahoma 73112, United States
  • Oklahoma City, Oklahoma 73118, United States
  • Oklahoma City, Oklahoma 73120, United States
  • Eugene, Oregon 97404, United States
  • Portland, Oregon 97210, United States
  • Portland, Oregon 97239, United States

Showing the first 100 of 133 sites.

08

References and documents

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. PubMed 20009055 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00105547
Lead sponsor
Myrexis Inc.
First posted
Mar 16, 2005
Start date
Feb 2005
Completion
May 2008
Last update
May 5, 2009

Study contacts

Ed Swabb, MD
study director · Myrexis Inc.

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2009. You cannot join it, but the record below documents what was studied.

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