Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
Tracking Information | |||||
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First Received Date ICMJE | November 22, 2005 | ||||
Last Updated Date | May 5, 2008 | ||||
Start Date ICMJE | November 2005 | ||||
Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Cognitive function [ Time Frame: Change from baseline at wk 12 ] [ Designated as safety issue: No ] | ||||
Original Primary Outcome Measures ICMJE |
Cognitive function | ||||
Change History | Complete list of historical versions of study NCT00257673 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Other Cognitive Assessments, activities of daily living, functional assessments and safety [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE |
Other Cognitive Assessments, activities of daily living, functional assessments and safety | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease | ||||
Official Title ICMJE | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MEM 1003 in Patients With Mild to Moderate Alzheimer's Disease | ||||
Brief 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. |
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Detailed 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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
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Condition ICMJE | Alzheimer's Disease | ||||
Intervention ICMJE |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 183 | ||||
Completion Date | October 2007 | ||||
Primary Completion Date | October 2007 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion criteria:
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Gender | Both | ||||
Ages | 50 Years to 90 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00257673 | ||||
Other Study ID Numbers ICMJE | MEM 1003-004 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Amy S. Domanowski, Ph.D., Head Regulatory Affairs, Memory Pharmaceuticals Corp. | ||||
Study Sponsor ICMJE | Memory Pharmaceuticals | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Memory Pharmaceuticals | ||||
Verification Date | May 2008 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |