Safety and Efficacy of MEM 1003 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:
NCT00257673
First received: November 22, 2005
Last updated: May 5, 2008
Last verified: May 2008
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Drug: MEM 1003
Drug: Placebo for MEM 1003
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Memory Pharmaceuticals:

Primary Outcome Measures:
  • Cognitive function [ Time Frame: Change from baseline at wk 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Other Cognitive Assessments, activities of daily living, functional assessments and safety [ Designated as safety issue: Yes ]

Enrollment: 183
Study Start Date: November 2005
Study Completion Date: October 2007
Primary Completion Date: October 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A
Active 30 mg MEM 1003
Drug: MEM 1003
30 mg twice a day
Experimental: B
90 mg MEM 1003
Drug: MEM 1003
90 mg MEM 1003 twice a day
Placebo Comparator: C
Placebo for MEM 1003
Drug: Placebo for MEM 1003
Placebo twice a day

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.

  Eligibility

Ages Eligible for Study:   50 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00257673

  Show 57 Study Locations
Sponsors and Collaborators
Memory Pharmaceuticals
Investigators
Study Director: Stephen Murray, MD, PhD Memory Pharmaceutical Corp.
  More Information

No publications provided

Responsible Party: Amy S. Domanowski, Ph.D., Head Regulatory Affairs, Memory Pharmaceuticals Corp.
ClinicalTrials.gov Identifier: NCT00257673     History of Changes
Obsolete Identifiers: NCT00605501
Other Study ID Numbers: MEM 1003-004
Study First Received: November 22, 2005
Last Updated: May 5, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by Memory Pharmaceuticals:
Cognition
Alzheimer's
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 April 17, 2014