Safety and Efficacy of MEM 3454 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Drug: MEM 3454 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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 |
| Estimated Enrollment: | 80 |
| 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.
Eligibility| Ages Eligible for Study: | 50 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosis of probable or possible Alzheimer's disease
- MMSE score between 16 and 26 points
- Modified Hachinski Ischemia Score of less than or equal to 4
- Capable of performing cognitive tests and other procedures specified in protocol
Exclusion Criteria:
- Head trauma associated with cognitive impairment
- Evidence of significant neurological disease other than AD, such as Parkinson's disease, multi-infarct dementia, Huntington's disease, normal pressure hydrocephalus, CNS tumor, progressive supranuclear palsy, seizure disorder, etc.
- Received AChE inhibitor therapy (e.g., rivastigmine, tacrine or galantamine) or NDMA-receptor antagonist, memantine, within 30 days or donepezil within 40 days of randomization
- Received any investigational drug within 2 months of randomization or treatment with other nicotinic receptor agonists within 3 months of screening
Contacts and Locations| 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 |
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00454870 History of Changes |
| Other Study ID Numbers: | MEM 3454-003 |
| Study First Received: | March 30, 2007 |
| Last Updated: | May 5, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Memory Pharmaceuticals:
|
Alzheimer's Disease Cognition Cognitive impairment |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on May 23, 2013