Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
NCT ID: NCT00257673
Last Updated: 2008-05-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
183 participants
INTERVENTIONAL
2005-11-30
2007-10-31
Brief Summary
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Detailed Description
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Perturbations in calcium homeostasis in the central nervous system, such as those associated with Alzheimer's disease and aging as well as stroke and head trauma can result in an increase in intracellular levels of calcium (Ca2+). Increased levels of Ca2+ may lead to cellular dysregulation and cell death. The role of calcium in these neurodegenerative processes led to the hypothesis that controlling calcium levels may be beneficial, particularly where progressive neuronal damage results in cognitive dysfunction and memory loss.
MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel modulators.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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A
Active 30 mg MEM 1003
MEM 1003
30 mg twice a day
B
90 mg MEM 1003
MEM 1003
90 mg MEM 1003 twice a day
C
Placebo for MEM 1003
Placebo for MEM 1003
Placebo twice a day
Interventions
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MEM 1003
30 mg twice a day
MEM 1003
90 mg MEM 1003 twice a day
Placebo for MEM 1003
Placebo twice a day
Eligibility Criteria
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Inclusion Criteria
* diagnosis of probable Alzheimer's disease
* magnetic resonance imaging or computed tomography examination compatible with AD
* modified Hachinski Ischemia Score of less than or equal to 4
* currently receiving no AD therapy or currently receiving donepezil, rivastigmine, or galantamine
Exclusion Criteria
* history of vascular dementia stroke, transient cerebral ischemic episodes, major depression, major psychotic disorder, or symptomatic postural hypotension
* treatment for Alzheimer's disease other than donepezil, rivastigmine, or galantamine; tacrine is not permitted in the last 30 days or memantine in the last 90 days
* treatment with calcium channel blockers or any investigational medications within the prior 30 days
50 Years
90 Years
ALL
No
Sponsors
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Memory Pharmaceuticals
INDUSTRY
Responsible Party
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Memory Pharmaceuticals Corp.
Principal Investigators
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Stephen Murray, MD, PhD
Role: STUDY_DIRECTOR
Memory Pharmaceutical Corp.
Locations
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Northport, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
El Centro, California, United States
Riverside, California, United States
San Francisco, California, United States
Torrence, California, United States
Hamden, Connecticut, United States
Washington D.C., District of Columbia, United States
Brooksville, Florida, United States
Chiefland, Florida, United States
Coral Springs, Florida, United States
Deerfield Beach, Florida, United States
Delray Beach, Florida, United States
Hallandale, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Port Charlotte, Florida, United States
Sarasota, Florida, United States
St. Petersburg, Florida, United States
Sunrise, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
West Palm Beach, Florida, United States
Atlanta, Georgia, United States
Decatur, Georgia, United States
Chicago, Illinois, United States
New Orleans, Louisiana, United States
Shreveport, Louisiana, United States
Towson, Maryland, United States
Fall River, Massachusetts, United States
Saint Loius, Missouri, United States
Berlin, New Jersey, United States
Long Branch, New Jersey, United States
Princeton, New Jersey, United States
Ridgewood, New Jersey, United States
Toms River, New Jersey, United States
Albany, New York, United States
Staten Island, New York, United States
Morganton, North Carolina, United States
Portland, Oregon, United States
Colmar, Pennsylvania, United States
Media, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Spartanburg, South Carolina, United States
Johnson City, Tennessee, United States
Bedford, Texas, United States
Bulverde, Texas, United States
San Antonio, Texas, United States
Midvale, Utah, United States
Bennington, Vermont, United States
Norfolk, Virginia, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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MEM 1003-004
Identifier Type: -
Identifier Source: org_study_id
NCT00605501
Identifier Type: -
Identifier Source: nct_alias