Safety and Efficacy of MEM 1003 Versus Placebo in Patients With Mild to Moderate Alzheimer's Disease

May 5, 2008 updated by: Memory Pharmaceuticals

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

183

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Northport, Alabama, United States, 35476
    • Arizona
      • Mesa, Arizona, United States, 85201
      • Phoenix, Arizona, United States, 85013
      • Sun City, Arizona, United States, 85351
    • California
      • El Centro, California, United States, 92243
      • Riverside, California, United States, 92506
      • San Francisco, California, United States, 94109
      • Torrence, California, United States, 90505
    • Connecticut
      • Hamden, Connecticut, United States, 06518
    • District of Columbia
      • Washington, DC, District of Columbia, United States, 20007
    • Florida
      • Brooksville, Florida, United States, 34613
      • Chiefland, Florida, United States, 32626
      • Coral Springs, Florida, United States, 33065
      • Deerfield Beach, Florida, United States, 33064
      • Delray Beach, Florida, United States, 33445
      • Hallandale Beach, Florida, United States, 33009
      • Hialeah, Florida, United States, 33016
      • Miami, Florida, United States, 33173
      • Miami, Florida, United States, 33137
      • Miami, Florida, United States, 33143
      • Plantation, Florida, United States, 33317
      • Port Charlotte, Florida, United States, 33952
      • Sarasota, Florida, United States, 34243
      • St. Petersburg, Florida, United States, 33701
      • Sunrise, Florida, United States, 33351
      • Tampa, Florida, United States, 33609
      • Tampa, Florida, United States, 33647
      • West Palm Beach, Florida, United States, 33409
    • Georgia
      • Atlanta, Georgia, United States, 30342
      • Decatur, Georgia, United States, 30030
    • Illinois
      • Chicago, Illinois, United States, 60610
    • Louisiana
      • New Orleans, Louisiana, United States, 70114
      • Shreveport, Louisiana, United States, 71104
    • Maryland
      • Towson, Maryland, United States, 21286
    • Massachusetts
      • Fall River, Massachusetts, United States, 02721
    • Missouri
      • St Loius, Missouri, United States, 63141
    • New Jersey
      • Berlin, New Jersey, United States, 08009
      • Long Branch, New Jersey, United States, 07740
      • Princeton, New Jersey, United States, 08560
      • Ridgewood, New Jersey, United States, 07450
      • Toms River, New Jersey, United States, 08755
    • New York
      • Albany, New York, United States, 12208
      • Staten Island, New York, United States, 10312
    • North Carolina
      • Morganton, North Carolina, United States, 28655
    • Oregon
      • Portland, Oregon, United States, 97210
    • Pennsylvania
      • Colmar, Pennsylvania, United States, 18915
      • Media, Pennsylvania, United States, 19063
      • Philadelphia, Pennsylvania, United States, 19149
    • South Carolina
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Johnson City, Tennessee, United States, 37601
    • Texas
      • Bedford, Texas, United States, 76021
      • Bulverde, Texas, United States, 78163
      • San Antonio, Texas, United States, 78217
    • Utah
      • Midvale, Utah, United States, 84047
    • Vermont
      • Bennington, Vermont, United States, 05201
    • Virginia
      • Norfolk, Virginia, United States, 23507
    • Washington
      • Spokane, Washington, United States, 99204

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: A
Active 30 mg MEM 1003
Drug: MEM 1003
30 mg twice a day
Drug: MEM 1003
90 mg MEM 1003 twice a day
EXPERIMENTAL: B
90 mg MEM 1003
Drug: MEM 1003
30 mg twice a day
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cognitive function
Time Frame: Change from baseline at wk 12
Change from baseline at wk 12

Secondary Outcome Measures

Outcome Measure
Other Cognitive Assessments, activities of daily living, functional assessments and safety

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memory Pharmaceuticals

Investigators

  • Study Director: Stephen Murray, MD, PhD, Memory Pharmaceutical Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (ACTUAL)

October 1, 2007

Study Completion (ACTUAL)

October 1, 2007

Study Registration Dates

First Submitted

November 22, 2005

First Submitted That Met QC Criteria

November 22, 2005

First Posted (ESTIMATE)

November 23, 2005

Study Record Updates

Last Update Posted (ESTIMATE)

May 6, 2008

Last Update Submitted That Met QC Criteria

May 5, 2008

Last Verified

May 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEM 1003-004

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.

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