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Safety and Efficacy of MEM 1003 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: NCT00257673
Recruitment Status : Completed
First Posted : November 23, 2005
Last Update Posted : May 6, 2008
Sponsor:
Information provided by:
Memory Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE November 22, 2005
First Posted Date  ICMJE November 23, 2005
Last Update Posted Date May 6, 2008
Study Start Date  ICMJE November 2005
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 5, 2008)
Cognitive function [ Time Frame: Change from baseline at wk 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: November 22, 2005)
Cognitive function
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 22, 2005)
Other Cognitive Assessments, activities of daily living, functional assessments and safety
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease
Official Title  ICMJE A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Safety and Efficacy of MEM 1003 in Patients With Mild to Moderate Alzheimer's Disease
Brief Summary The purpose of this study is to determine in a 12-week treatment study if MEM 1003 is a safe and effective treatment for patients with mild to moderate Alzheimer's disease.
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.

Perturbations in calcium homeostasis in the central nervous system, such as those associated with Alzheimer's disease and aging as well as stroke and head trauma can result in an increase in intracellular levels of calcium (Ca2+). Increased levels of Ca2+ may lead to cellular dysregulation and cell death. The role of calcium in these neurodegenerative processes led to the hypothesis that controlling calcium levels may be beneficial, particularly where progressive neuronal damage results in cognitive dysfunction and memory loss.

MEM 1003 is the (+)-enantiomer of a dihydropyridine that has been optimized for central nervous system activity. It inhibits L-type Ca2+ channels and within the anticipated human dosing range has more benign cardiovascular effects than other DHP L-Type calcium channel modulators.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Alzheimer's Disease
Intervention  ICMJE
  • Drug: MEM 1003
    30 mg twice a day
  • Drug: MEM 1003
    90 mg MEM 1003 twice a day
  • Drug: Placebo for MEM 1003
    Placebo twice a day
Study Arms  ICMJE
  • Experimental: A
    Active 30 mg MEM 1003
    Intervention: Drug: MEM 1003
  • Experimental: B
    90 mg MEM 1003
    Intervention: Drug: MEM 1003
  • Placebo Comparator: C
    Placebo for MEM 1003
    Intervention: Drug: Placebo for MEM 1003
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 5, 2008)
183
Original Enrollment  ICMJE
 (submitted: November 22, 2005)
180
Actual Study Completion Date  ICMJE October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • standardized MMSE Score of 10 to 24 points
  • diagnosis of probable Alzheimer's disease
  • magnetic resonance imaging or computed tomography examination compatible with AD
  • modified Hachinski Ischemia Score of less than or equal to 4
  • currently receiving no AD therapy or currently receiving donepezil, rivastigmine, or galantamine

Exclusion criteria:

  • head injury associated with cognitive impairment
  • history of vascular dementia stroke, transient cerebral ischemic episodes, major depression, major psychotic disorder, or symptomatic postural hypotension
  • treatment for Alzheimer's disease other than donepezil, rivastigmine, or galantamine; tacrine is not permitted in the last 30 days or memantine in the last 90 days
  • treatment with calcium channel blockers or any investigational medications within the prior 30 days
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00257673
Other Study ID Numbers  ICMJE MEM 1003-004
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amy S. Domanowski, Ph.D., Head Regulatory Affairs, Memory Pharmaceuticals Corp.
Study Sponsor  ICMJE Memory Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Stephen Murray, MD, PhD Memory Pharmaceutical Corp.
PRS Account Memory Pharmaceuticals
Verification Date May 2008

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