Alzheimer's DiseasePhase 3NCT00380276
Open-Label Treatment With MPC-7869 for Patients With Alzheimer's Who Previously Participated in an MPC-7869 Protocol
A Phase 3 study testing MPC-7869 in people with Alzheimer's Disease, run by Myrexis Inc. at 90 sites in 2 countries.
Trial summary
Open-label treatment with MPC-7869 for participants in a previous randomized study. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Alzheimer's Disease
- What is being tested?
- MPC-7869
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 90 sitesin 2 countries
- Study dates
- Sep 2006to Dec 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
- Participation in a previous MPC-7869 randomized protocol
- 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.
- Female subjects must be surgically sterile or postmenopausal for > 1 year.
- Subjects must have a reliable caregiver who can read, understand and speak English or Spanish.
Who cannot join
- 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.
Trial locations and contacts
90 sites in 2 countries.
90 sites in 2 countries
United States84 sites
Study site
Alabaster, Alabama
Study site
Albany, New York
Study site
Albuquerque, New Mexico
Study site
Alexandria, Virginia
Study site
Ann Arbor, Michigan
Study site
Atlanta, Georgia
Study site
Baltimore, Maryland
Study site
Beaufort, South Carolina
Study site
Bennington, Vermont
Study site
Boston, Massachusetts
Study site
Brooklyn, New York
Study site
Centerville, Ohio
Study site
Charleston, South Carolina
Study site
Charlottesville, Virginia
Study site
Chicago, Illinois
Study site
Columbus, Ohio
Study site
Costa Mesa, California
Study site
Dallas, Texas
Study site
Danbury, Connecticut
Study site
Darien, Connecticut
Study site
Deerfield Beach, Florida
Study site
Durham, North Carolina
Study site
East Providence, Rhode Island
Study site
Elmsford, New York
Study site
Eugene, Oregon
Study site
Fort Meyers, Florida
Study site
Fort Myers, Florida
Study site
Fort Wayne, Indiana
Study site
Glen Burnie, Maryland
Study site
Grand Rapids, Michigan
Study site
Greer, South Carolina
Study site
Hollywood, Florida
Study site
Houston, Texas
Study site
Huntsville, Alabama
Study site
Indianapolis, Indiana
Study site
Irvine, California
Study site
Jacksonville, Florida
Study site
Jenkintown, Pennsylvania
Study site
Kenilworth, New Jersey
Study site
Lafayette, California
Study site
Laguna Hills, California
Study site
Lebanon, New Hampshire
Study site
Lexington, Kentucky
Study site
Long Beach, California
Study site
Memphis, Tennessee
Study site
Miami, Florida
Study site
Middleton, Wisconsin
Study site
Milwaukee, Wisconsin
Study site
Morristown, New Jersey
Study site
Naples, Florida
Study site
Nashville, Tennessee
Study site
New Haven, Connecticut
Study site
New York, New York
Study site
Ogden, Utah
Study site
Oklahoma City, Oklahoma
Study site
Olean, New York
Study site
Philadelphia, Pennsylvania
Study site
Phoenix, Arizona
Study site
Pittsburgh, Pennsylvania
Study site
Portland, Oregon
Study site
Princeton, New Jersey
Study site
Raleigh, North Carolina
Study site
Rancho Mirage, California
Study site
Rochester, Minnesota
Study site
Rochester, New York
Study site
Sacramento, California
Study site
Salt Lake City, Utah
Study site
San Antonio, Texas
Study site
San Diego, California
Study site
San Francisco, California
Study site
Scotland, Pennsylvania
Study site
St Louis, Missouri
Study site
Stratford, New Jersey
Study site
Sun City, Arizona
Study site
Sunrise, Florida
Study site
Syracuse, New York
Study site
Tampa, Florida
Study site
Toledo, Ohio
Study site
Tucson, Arizona
Study site
Virginia Beach, Virginia
Study site
Vista, California
Study site
Washington D.C., District of Columbia
Study site
West Palm Beach, Florida
Study site
West Yarmouth, Massachusetts
Canada6 sites
Study site
Halifax, Nova Scotia
Study site
Kingston, Ontario
Study site
Ottawa, Ontario
Study site
Regina, Saskatchewan
Study site
Toronto, Ontario
Study site
Winnepeg, Manitoba
About this study
Official title: Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type
Open-label treatment with MPC-7869 for participants in a previous randomized study.
- Conditions
- Alzheimer's Disease
- 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
800 mg BID Oral dosing
| Study group | Role | What they receive |
|---|---|---|
| Open Label Arm | Other | Treatment is open-label Receives: Drug: MPC-7869 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Safety
Measured: For study duration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2006 (estimated)
- Study startSep 2006
- Study completionDec 2008 (estimated)
Why it stopped: Myriad has discontinued the development of Flurizan.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alzheimer's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Myrexis Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Mark Laughlin, MD, Study director, Myrexis Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00380276
- Sponsor's protocol ID
- MPC-7869-05-009
- Status last verified
- Aug 2008
- First submitted
- 21 Sep 2006
- Last updated
- 5 Aug 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Study of the Effect of Daily Treatment With MPC-7869 in Subjects With Dementia of the Alzheimer's Type
- ClinicalTrials.gov ID
- NCT00380276
- Acronym / sponsor ID
- MPC-7869-05-009
- Conditions
- Alzheimer's Disease
- Keywords
- Alzheimer's, Dementia, Dementia of Alzheimer Type
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Myriad has discontinued the development of Flurizan.
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Myrexis Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 25 Sep 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Open-label treatment with MPC-7869 for participants in a previous randomized study.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Arm | Other | Drug: MPC-7869Treatment is open-label |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participation in a previous MPC-7869 randomized protocol
- 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.
- Female subjects must be surgically sterile or postmenopausal for > 1 year.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MPC-7869800 mg BID Oral dosing | Drug | Open Label Arm |
Primary outcome
Primary Safety
Time frame: For study duration
Results and safety
The study was stopped early (reason given: Myriad has discontinued the development of Flurizan.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark Laughlin, MD study director
Myrexis Inc.
90 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MPC-7869 in people with Alzheimer's Disease, run by Myrexis Inc. at 90 sites in 2 countries.
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 6 inclusion and 3 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: stopped early, as of the sponsor's last update on 5 Aug 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 90 sites in United States, Canada. 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. 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 was stopped early (reason given: Myriad has discontinued the development of Flurizan.). Results are not available in the source record.
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?
Primary Safety (time frame: For study duration). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Aug 2008.