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

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. Identifier: NCT00257673
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : May 6, 2008
Information provided by:
Memory Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: MEM 1003 Drug: Placebo for MEM 1003 Phase 2

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 : Interventional  (Clinical Trial)
Actual Enrollment : 183 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : November 2005
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: A
Active 30 mg MEM 1003
Drug: MEM 1003
30 mg twice a day

Experimental: B
90 mg MEM 1003
Drug: MEM 1003
90 mg MEM 1003 twice a day

Placebo Comparator: C
Placebo for MEM 1003
Drug: Placebo for MEM 1003
Placebo twice a day

Primary Outcome Measures :
  1. Cognitive function [ Time Frame: Change from baseline at wk 12 ]

Secondary Outcome Measures :
  1. Other Cognitive Assessments, activities of daily living, functional assessments and safety

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.

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Ages Eligible for Study:   50 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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, or galantamine

Exclusion criteria:

  • head injury associated with cognitive impairment
  • 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

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 identifier (NCT number): NCT00257673

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Sponsors and Collaborators
Memory Pharmaceuticals
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Study Director: Stephen Murray, MD, PhD Memory Pharmaceutical Corp.
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Responsible Party: Amy S. Domanowski, Ph.D., Head Regulatory Affairs, Memory Pharmaceuticals Corp. Identifier: NCT00257673    
Obsolete Identifiers: NCT00605501
Other Study ID Numbers: MEM 1003-004
First Posted: November 23, 2005    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: May 2008
Keywords provided by Memory Pharmaceuticals:
Cognitive impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders