Trial record 1 of 1 for:
NCT00322036
Global Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT00322036 |
|
Recruitment Status :
Terminated
(Myriad has discontinued the development of Flurizan.)
First Posted : May 4, 2006
Last Update Posted : August 5, 2008
|
Sponsor:
Myrexis Inc.
Information provided by:
Myrexis Inc.
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Brief 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. Subjects may be taking approved medication for Alzheimer's disease provided the dose has been stable for at least 6 months.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer Disease Dementia | Drug: MPC-7869 | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 800 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Study Start Date : | May 2006 |
| Estimated Study Completion Date : | December 2008 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Alzheimer disease
| Arm | Intervention/treatment |
|---|---|
|
Experimental: 1
Oral 800 mg BID dosing
|
Drug: MPC-7869
Oral 800 mg BID |
|
Placebo Comparator: 2
Oral BID dosing
|
Drug: MPC-7869
Oral BID dosing |
Primary Outcome Measures :
- Cognition and activities of daily living [ Time Frame: 18 mos ]
Secondary Outcome Measures :
- Global function and cognition [ Time Frame: 18 months ]
Information from the National Library of Medicine
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 55 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00322036
Locations
Show 92 study locations
Sponsors and Collaborators
Myrexis Inc.
Investigators
| Study Director: | Mark Laughlin, MD | Myrexis Inc. |
| Responsible Party: | Ed Swabb, MD, Myriad Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00322036 |
| Other Study ID Numbers: |
MPC-7869-05-010.01 |
| First Posted: | May 4, 2006 Key Record Dates |
| Last Update Posted: | August 5, 2008 |
| Last Verified: | August 2008 |
Keywords provided by Myrexis Inc.:
|
Alzheimer Disease Dementia |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders Flurbiprofen Analgesics |
Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Anti-Inflammatory Agents Antirheumatic Agents Cyclooxygenase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |