Alzheimer DiseasePhase 3NCT00322036
Global 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 92 sites in 12 countries.
Trial summary
This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. Study subjects will have the diagnosis of mild dementia of the Alzheimer's type. 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
- 800 participants
- Where
- 92 sitesin 12 countries
- Study dates
- May 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
- Have had a diagnosis of probable Alzheimer's disease
- Men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
- Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
- Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures.
- At least 6 years of education, or sufficient work history to exclude mental retardation.
- Female subjects must be surgically sterile or postmenopausal for > 1 year.
- Adequate vision and hearing to participate in study assessments.
- Subjects must have a reliable caregiver who can read, understand and speak same language.
Who cannot join
- Current evidence of other causes of dementia.. .
- History of, 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.
- 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.
- Previous participation in an MPC-7869 clinical study.
Trial locations and contacts
92 sites in 12 countries.
92 sites in 12 countries
United States23 sites
Study site
Boston, Massachusetts
Study site
Charleston, South Carolina
Study site
Chicago, Illinois
Study site
Costa Mesa, California
Study site
Dallas, Texas
Study site
Deerfield Beach, Florida
Study site
Delray Beach, Florida
Study site
Farmington Hills, Michigan
Study site
Gainsville, Florida
Study site
Hollywood, Florida
Study site
Indianapolis, Indiana
Study site
Lexington, Kentucky
Study site
Miami, Florida
Study site
New Haven, Connecticut
Study site
Phoenix, Arizona
Study site
Providence, Rhode Island
Study site
Rochester, New York
Study site
Salt Lake City, Utah
Study site
San Diego, California
Study site
St Louis, Missouri
Study site
Tampa, Florida
Study site
Tucson, Arizona
Study site
West Palm Beach, Florida
Canada16 sites
Study site
Calgary, Alberta
Study site
Greenfield Park, Quebec
Study site
Halifax, Nova Scotia
Study site
Kingston, Ontario
Study site
London, Ontario
Study site
Medicine Hat, Alberta
Study site
Moncton, New Brunswick
Study site
Montreal, Quebec
Study site
Ottawa, Ontario
Study site
Peterborough, Ontario
Study site
Regina, Saskatchewan
Study site
Saint John, New Brunswick
Study site
Toronto, Ontario
Study site
Vancouver, British Columbia
Study site
Verdun, Quebec
Study site
Winnipeg, Manitoba
Germany12 sites
Study site
Berlin
Study site
Bochum
Study site
Bonn
Study site
Darmstadt
Study site
Düsseldorf
Study site
Freiburg im Breisgau
Study site
Hamburg
Study site
Heidelberg
Study site
Leipzig
Study site
Mannheim
Study site
München
Study site
Schwerin
France10 sites
Study site
Bordeaux
Study site
Dijon
Study site
Marseille
Study site
Montpellier
Study site
Nice
Study site
Reims
Study site
Rennes
Study site
Saint-Herblain
Study site
Toulouse
Study site
Tours
United Kingdom9 sites
Study site
Bath, England
Study site
Belfast, Northern Ireland
Study site
Glasgow, Scotland
Study site
London, England
Study site
Oxford, England
Study site
Penarth, Wales
Study site
Sheffield, England
Study site
Southhampton
Study site
Swindon, England
Belgium6 sites
Study site
Aalst
Study site
Antwerp
Study site
Edegem
Study site
Hasselt
Study site
Leuven
Study site
Sint-Truiden
Italy5 sites
Study site
Brescia
Study site
Milan
Study site
Perugia
Study site
Pisa
Study site
Roma
Spain4 sites
Study site
Barcelona
Study site
Bilbao
Study site
Getafe. Madrid
Study site
Madrid
Netherlands3 sites
Study site
's-Hertogenbosch
Study site
Amsterdam
Study site
Blaricum
About this study
Official title: Phase 3 Multinational, 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
This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. 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.
- Conditions
- Alzheimer Disease, Dementia
- Being tested
- MPC-7869
- Keywords
- Alzheimer Disease, Dementia
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Oral 800 mg BID dosing Receives: Drug: MPC-7869 |
| 2 | Placebo comparator | Oral BID dosing Receives: Drug: MPC-7869 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognition and activities of daily living
Measured: 18 mos
Secondary outcomes (1)
Global function and cognition
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2006 (estimated)
- Study startMay 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 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 800 participants (actual)
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
- NCT00322036
- Sponsor's protocol ID
- MPC-7869-05-010.01
- Status last verified
- Aug 2008
- First submitted
- 2 May 2006
- Last updated
- 5 Aug 2008
- Results posted
- No
- Data monitoring committee
- Yes
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
- Phase 3 Multinational, 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
- ClinicalTrials.gov ID
- NCT00322036
- Acronym / sponsor ID
- MPC-7869-05-010.01
- Conditions
- Alzheimer Disease, Dementia
- Keywords
- Alzheimer Disease, Dementia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Myriad has discontinued the development of Flurizan.
- Enrolment
- 800 participants (actual)
- Lead sponsor
- Myrexis Inc.Industry (pharma, biotech, devices)
- Study start
- May 2006
- Study completion
- Dec 2008 (estimated)
- First posted
- 4 May 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.
This is a multinational, randomized, double blind, placebo controlled, parallel group study comparing the safety and efficacy of daily dosing of 800 mg twice daily MPC-7869 to placebo. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: MPC-7869Oral 800 mg BID dosing |
| 2 | Placebo comparator | Drug: MPC-7869Oral BID dosing |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Have had a diagnosis of probable Alzheimer's disease
- Men or women ages greater than or equal to 55 years and living in the community at the time of enrollment (ie, not living in a rest home or nursing care facility).
- Signed the subject Informed Consent Form (ICF) and is willing and able to participate for the duration of the study.
- Ability to read and understand English, Dutch, Danish, Flemish, French, German, Italian, Spanish or Swedish to ensure compliance with cognitive testing and study visit procedures.
- At least 6 years of education, or sufficient work history to exclude mental retardation.
Key exclusion criteria (5 listed)
- Current evidence of other causes of dementia.. .
- History of, 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.
- 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.
- Previous participation in an MPC-7869 clinical study.
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-7869Oral 800 mg BID | Drug | 1 |
| MPC-7869Oral BID dosing | Drug | 2 |
Primary outcome
Cognition and activities of daily living
Time frame: 18 mos
1 secondary outcome
Global function and cognition
Time frame: 18 months
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.
92 sites in 12 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 Disease and Dementia, run by Myrexis Inc. at 92 sites in 12 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 8 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: 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 92 sites in United States, Canada, Germany, France, United Kingdom and 7 more countries. 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 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?
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?
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.