Trial record 3 of 4 for:    MEM3454

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

This study has been completed.
Sponsor:
Information provided by:
Memory Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00454870
First received: March 30, 2007
Last updated: May 5, 2008
Last verified: May 2008
  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

Resource links provided by NLM:


Further study details as provided by Memory Pharmaceuticals:

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)
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.

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454870

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
Sponsors and Collaborators
Memory Pharmaceuticals
Investigators
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 October 01, 2014