Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease

Last updated: May 5, 2008
Sponsor: Memory Pharmaceuticals
Overall Status: Completed

Phase

2

Condition

Dementia

Memory Loss

Alzheimer's Disease

Treatment

N/A

Clinical Study ID

NCT00257673
MEM 1003-004
  • Ages 50-90
  • All Genders

Study Summary

The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe and effective treatment for patients with mild to moderate Alzheimer's disease.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • standardized MMSE Score of 10 to 24 points

  • 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, orgalantamine

Exclusion

Exclusion criteria:

  • head injury associated with cognitive impairment

  • history of vascular dementia stroke, transient cerebral ischemic episodes, majordepression, 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 theprior 30 days

Study Design

Total Participants: 183
Study Start date:
November 01, 2005
Estimated Completion Date:
October 31, 2007

Study Description

Alzheimer's disease is the leading cause of dementia and one of the most common diseases of the aging population. It is a chronic brain disease that involves gradual memory loss, decline in the ability to perform routine tasks, disorientation, difficulty in learning, loss of language skills, impairment of judgment, and personality changes in affected individuals. The neurodegenerative nature of the disease eventually leads to the failure of other organ systems and death.

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.

Connect with a study center

  • Northport, Alabama 35476
    United States

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  • Mesa, Arizona 85201
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  • Phoenix, Arizona 85013
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  • Sun City, Arizona 85351
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  • El Centro, California 92243
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  • Riverside, California 92506
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  • San Francisco, California 94109
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  • Torrence, California 90505
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  • Hamden, Connecticut 06518
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  • Washington, DC, District of Columbia 20007
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  • Brooksville, Florida 34613
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  • Chiefland, Florida 32626
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  • Coral Springs, Florida 33065
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  • Deerfield Beach, Florida 33064
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  • Delray Beach, Florida 33445
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  • Hallandale Beach, Florida 33009
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  • Hialeah, Florida 33016
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  • Miami, Florida 33143
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  • Plantation, Florida 33317
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  • Port Charlotte, Florida 33952
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  • Sarasota, Florida 34243
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  • St. Petersburg, Florida 33701
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  • Sunrise, Florida 33351
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  • Tampa, Florida 33609
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  • West Palm Beach, Florida 33409
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  • Atlanta, Georgia 30342
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  • Decatur, Georgia 30030
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  • Chicago, Illinois 60610
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  • New Orleans, Louisiana 70114
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  • Shreveport, Louisiana 71104
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  • Towson, Maryland 21286
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  • Fall River, Massachusetts 02721
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  • St Loius, Missouri 63141
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  • Berlin, New Jersey 08009
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  • Long Branch, New Jersey 07740
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  • Princeton, New Jersey 08560
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  • Ridgewood, New Jersey 07450
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  • Toms River, New Jersey 08755
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  • Albany, New York 12208
    United States

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  • Staten Island, New York 10312
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  • Morganton, North Carolina 28655
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  • Portland, Oregon 97210
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  • Colmar, Pennsylvania 18915
    United States

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  • Media, Pennsylvania 19063
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  • Philadelphia, Pennsylvania 19149
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  • Spartanburg, South Carolina 29303
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  • Johnson City, Tennessee 37601
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  • Bedford, Texas 76021
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  • Bulverde, Texas 78163
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  • San Antonio, Texas 78217
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  • Midvale, Utah 84047
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  • Bennington, Vermont 05201
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  • Norfolk, Virginia 23507
    United States

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  • Spokane, Washington 99204
    United States

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