Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00454870
Status:
COMPLETED
Last Update Posted:
2008-05-06
First Post:
2007-03-30
Brief Title:
Safety and Efficacy of MEM 3454 Versus Placebo in Patients With Mild to Moderate Alzheimers Disease
Sponsor:
Memory Pharmaceuticals
Organization:
Memory Pharmaceuticals
Study Overview
Official Title:
A Randomized Double-Blind Placebo Controlled Multi-Center Study of the PharmacodynamicsEfficacy Safety Tolerability and Pharmacokinetics of 3 Fixed Dosages of MEM 3454 5 mg 15 mg and 50 mg 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 an 8-week treatment study if MEM 3454 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
A consistent and marked change in the brains of patients with AD is degeneration of the cholinergic innervation in the hippocampus and cerebral cortex areas The activity of choline acetyl transferase ChAT is significantly reduced in these brain regions and a linear correlation is seen between the reduction in cortical ChAT activity and the progress of dementia indicating a progressive loss of cholinergic function
Receptor selective nicotinic alpha-7 receptor agonists can modulate acetylcholine in selective brain regions and contribute to symptomatic treatment of AD MEM 3454 is a novel nicotinic alpha-7 receptor selective partial agonist having serotonin type 3 5-HT3 receptor antagonist properties
A consistent and marked change in the brains of patients with AD is degeneration of the cholinergic innervation in the hippocampus and cerebral cortex areas The activity of choline acetyl transferase ChAT is significantly reduced in these brain regions and a linear correlation is seen between the reduction in cortical ChAT activity and the progress of dementia indicating a progressive loss of cholinergic function
Receptor selective nicotinic alpha-7 receptor agonists can modulate acetylcholine in selective brain regions and contribute to symptomatic treatment of AD MEM 3454 is a novel nicotinic alpha-7 receptor selective partial agonist having serotonin type 3 5-HT3 receptor antagonist properties
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