Ignite Creation Date:
2024-05-05 @ 12:08 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00257673
Status:
COMPLETED
Last Update Posted:
2008-05-06
First Post:
2005-11-22
Brief Title:
Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimers Disease
Sponsor:
Memory Pharmaceuticals
Organization:
Memory Pharmaceuticals
Study Overview
Official Title:
A Multicenter Randomized Double-Blind Placebo-Controlled Study to Evaluate Safety and Efficacy of MEM 1003 in Patients With Mild to Moderate Alzheimers Disease
Status:
COMPLETED
Status Verified Date:
2008-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Alzheimers disease
Detailed Description:
Alzheimers 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 Alzheimers 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
Perturbations in calcium homeostasis in the central nervous system such as those associated with Alzheimers 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None