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Alzheimer DiseasePhase 3NCT00105547

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

A Phase 3 study testing MPC-7869 in people with Alzheimer Disease and Dementia, run by Myrexis Inc. at 132 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 55 years and older
Conditions the study is for
Alzheimer Disease, Dementia
What is being tested?
MPC-7869
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,600 participants
Where
132 sitesUnited States
Study dates
Feb 2005to May 2008
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

132 sites in 1 country.

132 sites in 1 country

United States132 sites

  • Study site

    Alabaster, Alabama, 35007

  • Study site

    Albany, New York, 12205

  • Study site

    Albuquerque, New Mexico, 87102

  • Study site

    Alexandria, Virginia, 22304

  • Study site

    Atlanta, Georgia, 30328

  • Study site

    Austin, Texas, 78757

  • Study site

    Bala-Cynwyd, Pennsylvania, 19004

  • Study site

    Baltimore, Maryland, 21285

  • Study site

    Bay Harbor, Florida, 33154

  • Study site

    Beaufort, South Carolina, 29902

  • Study site

    Bennington, Vermont, 05201

  • Study site

    Boca Raton, Florida, 33486

  • Study site

    Boston, Massachusetts, 02118

  • Study site

    Brockton, Massachusetts, 02301

  • Study site

    Brooklyn, New York, 11201

  • Study site

    Brooklyn, New York, 11223

  • Study site

    Centerville, Ohio, 45459

  • Study site

    Charlottesville, Virginia, 22903

  • Study site

    Chicago, Illinois, 60194

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Clearwater, Florida, 33761-2010

  • Study site

    Columbus, Ohio, 43210

  • Study site

    Dallas, Texas, 75390

  • Study site

    Danbury, Connecticut, 06810

  • Study site

    Darien, Connecticut, 06820

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Denver, Colorado, 80218

  • Study site

    Derrfield Beach, Florida, 33064

  • Study site

    Durham, North Carolina, 27710

  • Study site

    East Providence, Rhode Island, 02914

  • Study site

    East Providence, Rhode Island, 02916

  • Study site

    Elmsford, New York, 10523

  • Study site

    Eugene, Oregon, 97404

  • Study site

    Farmington Hills, Michigan, 48334

  • Study site

    Fort Lauderdale, Florida, 33321

  • Study site

    Fort Myers, Florida, 33912

  • Study site

    Fort Myers, Florida, 33916

  • Study site

    Fort Wayne, Indiana, 46805

  • Study site

    Fresno, California, 93720

  • Study site

    Galveston, Texas, 77555-0539

  • Study site

    Glen Burnie, Maryland, 21061

  • Study site

    Grand Rapids, Michigan, 49525

  • Study site

    Greer, South Carolina, 29651

  • Study site

    Hialeah, Florida, 33016

  • Study site

    Hollywood, Florida, 33021

  • Study site

    Houston, Texas, 77030

  • Study site

    Huntsville, Alabama, 35801

  • Study site

    Indianapolis, Indiana, 46260

  • Study site

    Irvine, California, 92697-4540

  • Study site

    Jacksonville, Florida, 32216

  • Study site

    Jacksonville, Florida, 32224

  • Study site

    Jenkintown, Pennsylvania, 19046

  • Study site

    Johnson City, Tennessee, 37601

  • Study site

    Kansas City, Missouri, 64114

  • Study site

    Kenilworth, New Jersey, 07033

  • Study site

    La Jolla, California, 90237

  • Study site

    Lafayette, California, 94549

  • Study site

    Laguna Hills, California, 92653

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Lexington, Kentucky, 40504

  • Study site

    Little Rock, Arkansas, 72205

  • Study site

    Long Beach, California, 90822

  • Study site

    Los Angeles, California, 90033

  • Study site

    Memphis, Tennessee, 38105

  • Study site

    Mesa, Arizona, 85210

  • Study site

    Miami, Florida, 33144

  • Study site

    Middleton, Wisconsin, 53562

  • Study site

    Milwaukee, Wisconsin, 53226

  • Study site

    Morristown, New Jersey, 07960

  • Study site

    Naples, Florida, 34102

  • Study site

    Nashville, Tennessee, 37203

  • Study site

    New Haven, Connecticut, 06510

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New York, New York, 10016

  • Study site

    New York, New York, 10021

  • Study site

    New York, New York, 10032

  • Study site

    Newport Beach, California, 92660

  • Study site

    Newport Beach, California, 92663

  • Study site

    North Charleston, South Carolina, 29406-6076

  • Study site

    North Miami, Florida, 33161

  • Study site

    Ocala, Florida, 34471

  • Study site

    Oceanside, California, 92056

  • Study site

    Ogden, Utah, 84405

  • Study site

    Oklahoma City, Oklahoma, 73112

  • Study site

    Oklahoma City, Oklahoma, 73118

  • Study site

    Oklahoma City, Oklahoma, 73120

  • Study site

    Olean, New York, 14760

  • Study site

    Orlando, Florida, 32806

  • Study site

    Peoria, Arizona, 85381

  • Study site

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19107

  • Study site

    Philadelphia, Pennsylvania, 19115

  • Study site

    Phoenix, Arizona, 85013

  • Study site

    Piscataway, New Jersey, 08855

  • Study site

    Pittsburgh, Pennsylvania, 15206

  • Study site

    Pittsburgh, Pennsylvania, 15213

  • Study site

    Plantation, Florida, 33324

  • Study site

    Pompano Beach, Florida, 33060

  • Study site

    Portland, Oregon, 97210

  • Study site

    Portland, Oregon, 97239

  • Study site

    Princeton, New Jersey, 08540

  • Study site

    Providence, Rhode Island, 02906

  • Study site

    Raleigh, North Carolina, 27607-6520

  • Study site

    Rancho Mirage, California, 92270

  • Study site

    Rochester, Minnesota, 55901

  • Study site

    Rochester, New York, 14620

  • Study site

    Sacramento, California, 95816

  • Study site

    Salt Lake City, Utah, 84107

  • Study site

    Salt Lake City, Utah, 84108

  • Study site

    San Antonio, Texas, 78229

  • Study site

    San Diego, California, 92103

  • Study site

    San Francisco, California, 94109

  • Study site

    San Francisco, California, 94143

  • Study site

    Scotland, Pennsylvania, 17254

  • Study site

    St Louis, Missouri, 63141

  • Study site

    Stratford, New Jersey, 08084

  • Study site

    Sun City, Arizona, 85351

  • Study site

    Syracuse, New York, 13210

  • Study site

    Tampa, Florida, 33609

  • Study site

    Tampa, Florida, 33613

  • Study site

    Tampa, Florida, 33617

  • Study site

    Tampa, Florida, 33647

  • Study site

    Toledo, Ohio, 43614

  • Study site

    Toms River, New Jersey, 08755

  • Study site

    Tucson, Arizona, 85741-3537

  • Study site

    Virginia Beach, Virginia, 23452

  • Study site

    Vista, California, 92083

  • Study site

    Washington D.C., District of Columbia, 20007

  • Study site

    West Palm Beach, Florida, 33407

  • Study site

    West Yarmouth, Massachusetts, 02673

  • Study site

    Wichita Falls, Texas, 76301

  • Study site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

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

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.

Being tested
MPC-7869
Keywords
Alzheimer's, Dementia, Dementia of Alzheimer Type
Medical subject headings
Alzheimer Disease, Dementia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MPC-7869Drug

    oral 800 mg BID

  • MPC-7869Drug

    Oral BID dosing

Study groups in NCT00105547
Study groupRoleWhat they receive
1Experimental800 mg BID
Receives: Drug: MPC-7869
2Placebo comparatorBID dosing
Receives: Drug: MPC-7869

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cognition and activities of daily living

    Measured: 18 mos

Secondary outcomes (1)

  1. Global function and behavior

    Measured: 18 mos

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Mar 2005 (estimated)
  2. Study startFeb 2005
  3. Study completionMay 2008

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
1,600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00105547
Sponsor's protocol ID
MPC-7869-04-005.02
Status last verified
May 2009
First submitted
15 Mar 2005
Last updated
5 May 2009
Results posted
No
Data monitoring committee
Yes

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MPC-7869 in people with Alzheimer Disease and Dementia, run by Myrexis Inc. at 132 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 May 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cognition and activities of daily living (time frame: 18 mos). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00105547, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2009.

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