Trial record 3 of 4 for:
flurizan
Efficacy Study of MPC-7869 to Treat Patients With Alzheimer's
This study has been completed.
Sponsor:
Myrexis Inc.
Information provided by:
Myrexis Inc.
ClinicalTrials.gov Identifier:
NCT00105547
First received: March 15, 2005
Last updated: May 3, 2009
Last verified: May 2009
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer Disease Dementia |
Drug: MPC-7869 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Further study details as provided by Myrexis Inc.:
Primary Outcome Measures:
- Cognition and activities of daily living [ Time Frame: 18 mos ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Global function and behavior [ Time Frame: 18 mos ] [ Designated as safety issue: No ]
| Enrollment: | 1600 |
| Study Start Date: | February 2005 |
| Study Completion Date: | May 2008 |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
800 mg BID
|
Drug: MPC-7869
oral 800 mg BID
|
|
Placebo Comparator: 2
BID dosing
|
Drug: MPC-7869
Oral BID dosing
|
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.
Eligibility| Ages Eligible for Study: | 55 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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:
- 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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00105547
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| United States, Alabama | |
| Alabaster, Alabama, United States, 35007 | |
| Huntsville, Alabama, United States, 35801 | |
| United States, Arizona | |
| Mesa, Arizona, United States, 85210 | |
| Peoria, Arizona, United States, 85381 | |
| Phoenix, Arizona, United States, 85013 | |
| Sun City, Arizona, United States, 85351 | |
| Tucson, Arizona, United States, 85741-3537 | |
| United States, Arkansas | |
| Little Rock, Arkansas, United States, 72205 | |
| United States, California | |
| Fresno, California, United States, 93720 | |
| Irvine, California, United States, 92697-4540 | |
| La Jolla, California, United States, 90237 | |
| Lafayette, California, United States, 94549 | |
| Laguna Hills, California, United States, 92653 | |
| Long Beach, California, United States, 90822 | |
| Los Angeles, California, United States, 90033 | |
| Newport Beach, California, United States, 92660 | |
| Newport Beach, California, United States, 92663 | |
| Oceanside, California, United States, 92056 | |
| Rancho Mirage, California, United States, 92270 | |
| Sacramento, California, United States, 95816 | |
| San Diego, California, United States, 92103 | |
| San Francisco, California, United States, 94109 | |
| San Francisco, California, United States, 94143 | |
| Vista, California, United States, 92083 | |
| United States, Colorado | |
| Denver, Colorado, United States, 80218 | |
| United States, Connecticut | |
| Danbury, Connecticut, United States, 06810 | |
| Darien, Connecticut, United States, 06820 | |
| New Haven, Connecticut, United States, 06510 | |
| United States, District of Columbia | |
| Washington, District of Columbia, United States, 20007 | |
| United States, Florida | |
| Bay Harbor, Florida, United States, 33154 | |
| Boca Raton, Florida, United States, 33486 | |
| Clearwater, Florida, United States, 33761-2010 | |
| Derrfield Beach, Florida, United States, 33064 | |
| Fort Myers, Florida, United States, 33916 | |
| Ft. Lauderdale, Florida, United States, 33321 | |
| Ft. Myers, Florida, United States, 33912 | |
| Hialeah, Florida, United States, 33016 | |
| Hollywood, Florida, United States, 33021 | |
| Jacksonville, Florida, United States, 32224 | |
| Jacksonville, Florida, United States, 32216 | |
| Miami, Florida, United States, 33144 | |
| Naples, Florida, United States, 34102 | |
| North Miami, Florida, United States, 33161 | |
| Ocala, Florida, United States, 34471 | |
| Orlando, Florida, United States, 32806 | |
| Plantation, Florida, United States, 33324 | |
| Pompano Beach, Florida, United States, 33060 | |
| Tampa, Florida, United States, 33617 | |
| Tampa, Florida, United States, 33613 | |
| Tampa, Florida, United States, 33647 | |
| Tampa, Florida, United States, 33609 | |
| West Palm Beach, Florida, United States, 33407 | |
| United States, Georgia | |
| Atlanta, Georgia, United States, 30328 | |
| Decatur, Georgia, United States, 30033 | |
| United States, Illinois | |
| Chicago, Illinois, United States, 60194 | |
| United States, Indiana | |
| Ft. Wayne, Indiana, United States, 46805 | |
| Indianapolis, Indiana, United States, 46260 | |
| United States, Kentucky | |
| Lexington, Kentucky, United States, 40504 | |
| United States, Louisiana | |
| New Orleans, Louisiana, United States, 70112 | |
| United States, Maryland | |
| Baltimore,, Maryland, United States, 21285 | |
| Glen Burnie, Maryland, United States, 21061 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02118 | |
| Brockton, Massachusetts, United States, 02301 | |
| West Yarmouth, Massachusetts, United States, 02673 | |
| United States, Michigan | |
| Farmington Hills, Michigan, United States, 48334 | |
| Grand Rapids, Michigan, United States, 49525 | |
| United States, Minnesota | |
| Rochester, Minnesota, United States, 55901 | |
| United States, Missouri | |
| Kansas City, Missouri, United States, 64114 | |
| St. Louis, Missouri, United States, 63141 | |
| United States, New Hampshire | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| Kenilworth, New Jersey, United States, 07033 | |
| Morristown, New Jersey, United States, 07960 | |
| Piscataway, New Jersey, United States, 08855 | |
| Princeton, New Jersey, United States, 08540 | |
| Stratford, New Jersey, United States, 08084 | |
| Toms River, New Jersey, United States, 08755 | |
| United States, New Mexico | |
| Albuquerque, New Mexico, United States, 87102 | |
| United States, New York | |
| Albany, New York, United States, 12205 | |
| Brooklyn, New York, United States, 11201 | |
| Brooklyn, New York, United States, 11223 | |
| Elmsford, New York, United States, 10523 | |
| New York, New York, United States, 10032 | |
| New York, New York, United States, 10016 | |
| New York, New York, United States, 10021 | |
| Olean, New York, United States, 14760 | |
| Rochester, New York, United States, 14620 | |
| Syracuse, New York, United States, 13210 | |
| United States, North Carolina | |
| Durham, North Carolina, United States, 27710 | |
| Raleigh, North Carolina, United States, 27607-6520 | |
| Winston-Salem, North Carolina, United States, 27103 | |
| United States, Ohio | |
| Centerville, Ohio, United States, 45459 | |
| Cincinnati, Ohio, United States, 45267 | |
| Columbus, Ohio, United States, 43210 | |
| Toledo, Ohio, United States, 43614 | |
| United States, Oklahoma | |
| Oklahoma City, Oklahoma, United States, 73118 | |
| Oklahoma City, Oklahoma, United States, 73120 | |
| Oklahoma City, Oklahoma, United States, 73112 | |
| United States, Oregon | |
| Eugene, Oregon, United States, 97404 | |
| Portland, Oregon, United States, 97210 | |
| Portland, Oregon, United States, 97239 | |
| United States, Pennsylvania | |
| Bala Cynwyd, Pennsylvania, United States, 19004 | |
| Jenkintown, Pennsylvania, United States, 19046 | |
| Philadelphia, Pennsylvania, United States, 19107 | |
| Philadelphia, Pennsylvania, United States, 19115 | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Pittsburg, Pennsylvania, United States, 15213 | |
| Pittsburgh, Pennsylvania, United States, 15206 | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| Scotland, Pennsylvania, United States, 17254 | |
| United States, Rhode Island | |
| East Providence, Rhode Island, United States, 02914 | |
| East Providence, Rhode Island, United States, 02916 | |
| Providence, Rhode Island, United States, 02906 | |
| United States, South Carolina | |
| Beaufort, South Carolina, United States, 29902 | |
| Greer, South Carolina, United States, 29651 | |
| North Charleston, South Carolina, United States, 29406-6076 | |
| United States, Tennessee | |
| Johnson City, Tennessee, United States, 37601 | |
| Memphis, Tennessee, United States, 38105 | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| Austin, Texas, United States, 78757 | |
| Dallas, Texas, United States, 75390 | |
| Galveston, Texas, United States, 77555-0539 | |
| Houston, Texas, United States, 77030 | |
| San Antonio, Texas, United States, 78229 | |
| Wichita Falls, Texas, United States, 76301 | |
| United States, Utah | |
| Ogden, Utah, United States, 84405 | |
| Salt Lake City, Utah, United States, 84108 | |
| Salt Lake City, Utah, United States, 84107 | |
| United States, Vermont | |
| Bennington, Vermont, United States, 05201 | |
| United States, Virginia | |
| Alexandria, Virginia, United States, 22304 | |
| Charlottesville, Virginia, United States, 22903 | |
| Virginia Beach, Virginia, United States, 23452 | |
| United States, Wisconsin | |
| Middleton, Wisconsin, United States, 53562 | |
| Milwaukee, Wisconsin, United States, 53226 | |
Sponsors and Collaborators
Myrexis Inc.
Investigators
| Study Director: | Ed Swabb, MD | Myrexis Inc. |
More Information
No publications provided by Myrexis Inc.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ed Swabb, MD, Myriad Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT00105547 History of Changes |
| Other Study ID Numbers: | MPC-7869-04-005.02 |
| Study First Received: | March 15, 2005 |
| Last Updated: | May 3, 2009 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Myrexis Inc.:
|
Alzheimer's Dementia Dementia of Alzheimer Type |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013