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Safety and Efficacy of MEM 3454 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00454870
Recruitment Status : Completed
First Posted : April 2, 2007
Last Update Posted : May 6, 2008
Sponsor:
Information provided by:
Memory Pharmaceuticals

Study Description
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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 Alzheimer's disease.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Drug: MEM 3454 Phase 2

Detailed Description:

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Actual Primary Completion Date : October 2007
Actual Study Completion Date : October 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   50 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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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): NCT00454870


Locations
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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
Sponsors and Collaborators
Memory Pharmaceuticals
Investigators
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Study Director: Stephen R Murray, MD, PhD Memory Pharmaceuticals Corp
More Information
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ClinicalTrials.gov Identifier: NCT00454870    
Other Study ID Numbers: MEM 3454-003
First Posted: April 2, 2007    Key Record Dates
Last Update Posted: May 6, 2008
Last Verified: May 2008
Keywords provided by Memory Pharmaceuticals:
Alzheimer's Disease
Cognition
Cognitive impairment
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders