- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00454870
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
Study Overview
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 Type
Enrollment (Anticipated)
Phase
- Phase 2
Contacts and Locations
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85013
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California
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Glendale, California, United States, 91206
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Georgia
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Atlanta, Georgia, United States, 30308
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Kansas
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Wichita, Kansas, United States, 67207
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Wichita, Kansas, United States, 67211
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New Jersey
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Willingboro, New Jersey, United States, 08046
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19139
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Stephen R Murray, MD, PhD, Memory Pharmaceuticals Corp
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEM 3454-003
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alzheimer's Disease
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University of Southern CaliforniaAlzheimer's Therapeutic Research Institute; American Heart Association; Schaeffer...RecruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
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University of Southern CaliforniaNational Institute on Aging (NIA); Alzheimer's Therapeutic Research Institute; Brigham and Women's Hospital and other collaboratorsActive, not recruitingDementia | Alzheimer Disease | Prodromal Alzheimer's Disease | Preclinical Alzheimer's DiseaseUnited States
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Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
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Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
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Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited States
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Novoic LimitedCompletedAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
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Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's DiseaseUnited Kingdom
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Novoic LimitedRecruitingAlzheimer Disease | Mild Cognitive Impairment | Prodromal Alzheimer's Disease | Alzheimer's Disease (Incl Subtypes) | Preclinical Alzheimer's Disease | Normal CognitionUnited States
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University Hospital, BordeauxMinistry for Health and Solidarity, FranceCompletedAlzheimer's Disease (AD) | Alzheimer's Disease (AD) Related DisordersFrance
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University of Colorado, DenverNational Institute on Aging (NIA)Active, not recruitingSuspected Typical Alzheimer's Disease (AD) | Suspected Atypical Alzheimer's Disease (AD)United States
Clinical Trials on MEM 3454
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Memory PharmaceuticalsHoffmann-La RocheUnknown
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Memory PharmaceuticalsUnknownCognitive Impairment Associated With SchizophreniaUnited States
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Memory PharmaceuticalsCompletedSafety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's DiseaseAlzheimer's DiseaseUnited States
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Memory PharmaceuticalsStanley Medical Research InstituteCompletedSafety and Efficacy of MEM 1003 Versus Placebo for the Treatment of Patients With Bipolar I DisorderBipolar Disorder With Manic or Mixed EpisodesUnited States
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University of KentuckyCompleted
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Brigham Young UniversityCompletedNeurorehabilitation | Memory DysfunctionUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingRecurrent Mantle Cell Lymphoma | Recurrent Diffuse Large B-Cell Lymphoma | Refractory Diffuse Large B-Cell Lymphoma | Refractory Mantle Cell Lymphoma | Transformed Recurrent Non-Hodgkin LymphomaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingRecurrent Mantle Cell Lymphoma | Refractory Mantle Cell LymphomaUnited States
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Memgen, Inc.H. Lee Moffitt Cancer Center and Research Institute; Duke Cancer InstituteRecruitingMelanoma | Head and Neck Cancer | Pancreatic Cancer | Solid Tumor | Non Small Cell Lung Cancer | Metastatic Cancer | Triple Negative Breast Cancer | Advanced Cancer | Merkel Cell Carcinoma | Cutaneous Squamous Cell CarcinomaUnited States
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City of Hope Medical CenterNational Cancer Institute (NCI)RecruitingRecurrent Glioblastoma | Refractory GlioblastomaUnited States