Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
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| ClinicalTrials.gov Identifier: NCT00257673 |
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Recruitment Status :
Completed
First Posted : November 23, 2005
Last Update Posted : May 6, 2008
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Alzheimer's Disease | Drug: MEM 1003 Drug: Placebo for MEM 1003 | Phase 2 |
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.
| 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 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: A
Active 30 mg MEM 1003
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Drug: MEM 1003
30 mg twice a day |
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Experimental: B
90 mg MEM 1003
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Drug: MEM 1003
90 mg MEM 1003 twice a day |
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Placebo Comparator: C
Placebo for MEM 1003
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Drug: Placebo for MEM 1003
Placebo twice a day |
- Cognitive function [ Time Frame: Change from baseline at wk 12 ]
- Other Cognitive Assessments, activities of daily living, functional assessments and safety
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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
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 ClinicalTrials.gov identifier (NCT number): NCT00257673
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| Study Director: | Stephen Murray, MD, PhD | Memory Pharmaceutical Corp. |
| Responsible Party: | Amy S. Domanowski, Ph.D., Head Regulatory Affairs, Memory Pharmaceuticals Corp. |
| ClinicalTrials.gov 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 |
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Cognition Alzheimer's Cognitive impairment |
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Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Neurocognitive Disorders Mental Disorders |