Safety and Efficacy of MEM 3454 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
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 Alzheimer's disease.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-Blind, Placebo Controlled, Multi-Center Study of the Pharmacodynamics/Efficacy, Safety, Tolerability, and Pharmacokinetics of 3 Fixed Dosages of MEM 3454 (5 mg, 15 mg, and 50 mg) in Patients With Mild to Moderate Alzheimer's Disease|
|Study Start Date:||February 2007|
|Study Completion Date:||October 2007|
|Primary Completion Date:||October 2007 (Final data collection date for primary outcome measure)|
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.
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.
|United States, Arizona|
|Phoenix, Arizona, United States, 85013|
|United States, California|
|Glendale, California, United States, 91206|
|United States, Georgia|
|Atlanta, Georgia, United States, 30308|
|United States, Kansas|
|Wichita, Kansas, United States, 67207|
|Wichita, Kansas, United States, 67211|
|United States, New Jersey|
|Willingboro, New Jersey, United States, 08046|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19139|
|Study Director:||Stephen R Murray, MD, PhD||Memory Pharmaceuticals Corp|