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. Identifier: NCT00454870
Recruitment Status : Completed
First Posted : April 2, 2007
Last Update Posted : May 6, 2008
Information provided by:
Memory Pharmaceuticals

March 30, 2007
April 2, 2007
May 6, 2008
February 2007
October 2007   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00454870 on Archive Site
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Safety and Efficacy of MEM 3454 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
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
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.

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.

Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Alzheimer's Disease
Drug: MEM 3454
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
October 2007
October 2007   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
50 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
United States
MEM 3454-003
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Memory Pharmaceuticals
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Study Director: Stephen R Murray, MD, PhD Memory Pharmaceuticals Corp
Memory Pharmaceuticals
May 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP