A Study of the Safety and Efficacy of Memantine in Moderate to Severe Alzheimer's Disease

August 25, 2010 updated by: Forest Laboratories

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Safety and Efficacy of Memantine in Patients With Moderate-to-Severe Dementia of the Alzheimer's Type

The objective of this study is to evaluate the safety, tolerability, and efficacy of memantine compared to placebo in outpatients diagnosed with moderate-to-severe dementia of the Alzheimer's type on a concurrent acetylcholinesterase inhibitor (AChEI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Memantine is a therapeutic agent that represents a unique class of Alzheimer's disease (AD) treatment options. A once daily (QD) dosing regimen in an AD population would simplify administration for the caregiver. The purpose of this study is to evaluate the safety and efficacy of modified release memantine taken once daily in outpatients with moderate-to-severe AD on a concurrent AChEI.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
677

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

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

  • Argentina
      • Buenos Aires, Argentina, 1419HDN
        • Forest Investigative Site 102
      • Buenos Aires, Argentina, C1062ABF
        • Forest Investigative Site 118
      • Buenos Aires, Argentina, C1117ABE
        • Forest Investigative Site 109
      • Buenos Aires, Argentina, C1122AAJ
        • Forest Investigative Site 104
      • Buenos Aires, Argentina, C1126AAB
        • Forest Investigative Site 108
      • Buenos Aires, Argentina, C1181ACH
        • Forest Investigative Site 114
      • Buenos Aires, Argentina, C1209AAB
        • Forest Investigative Site 106
      • Buenos Aires, Argentina, C1405CNF
        • Forest Investigative Site 119
      • Buenos Aires, Argentina, C1413FWO
        • Forest Investigative Site 122
      • Buenos Aires, Argentina, C1419AHN
        • Forest Investigative Site 107
      • Buenos Aires, Argentina, C1425AGP
        • Forest Investigative Site 111
      • Buenos Aires, Argentina, C1425BPK
        • Forest Investigative Site 121
      • Buenos Aires, Argentina, C1428AQK
        • Forest Investigative Site 115
      • Buenos Aires, Argentina, C1428AQK
        • Forest Investigative Site 116
      • Cordoba, Argentina, X5000ALB
        • Forest Investigative Site 112
      • Cordoba, Argentina, X5004AOA
        • Forest Investigative Site 124
      • Mendoza, Argentina, M5500HYF
        • Forest Investigative Site 110
      • Mendoza, Argentina, M5504FMI
        • Forest Investigative Site 125
      • Santa Fe, Argentina, S3000FWO
        • Forest Investigative Site 120
    • Buenos Aires
      • Banfield, Buenos Aires, Argentina, B1828CKR
        • Forest Investigative Site 103
      • La Plata, Buenos Aires, Argentina, B1900AVG
        • Forest Investigative Site 105
      • Lanus, Buenos Aires, Argentina, C1824IBR
        • Forest Investigative Site 123
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Forest Investigative Site 113
  • Chile
      • Antofagasta, Chile
        • Forest Investigative Site 302
      • Santiago, Chile
        • Forest Investigative Site 304
      • Santiago, Chile
        • Forest Investigative Site 312
      • Valdivia, Chile
        • Forest Investigative Site 306
    • Elqui
      • Coquimbo, Elqui, Chile
        • Forest Investigative Site 308
    • Santiago
      • Las Condes, Santiago, Chile
        • Forest Investigative Site 301
      • Las Condes, Santiago, Chile
        • Forest Investigative Site 309
      • Providencia, Santiago, Chile
        • Forest Investigative Site 303
      • Providencia, Santiago, Chile
        • Forest Investigative Site 310
      • Recoleta, Santiago, Chile
        • Forest Investigative Site 313
      • San Ramon, Santiago, Chile
        • Forest Investigative Site 305
  • Mexico
      • Aguascalientes, Mexico, 20230
        • Forest Investigative Site 206
      • San Luis Potosi, Mexico, 78090
        • Forest Investigative Site 210
    • Coahuila
      • Saltillo, Coahuila, Mexico, 25000
        • Forest Investigative Site 212
    • Federal District
      • Mexico City, Federal District, Mexico, 14000
        • Forest Investigative Site 202
      • Mexico City, Federal District, Mexico, 14050
        • Forest Investigative Site 207
    • Guanajuato
      • Leon, Guanajuato, Mexico, 37000
        • Forest Investigative Site 211
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44610
        • Forest Investigative Site 205
      • Zapopan, Jalisco, Mexico, 45200
        • Forest Investigative Site 203
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 44610
        • Forest Investigative Site 208
      • Monterrey, Nuevo Leon, Mexico, 64710
        • Forest Investigative Site 204
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80400
        • Forest Investigative Site 213
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Forest Investigative Site 010
    • California
      • Costa Mesa, California, United States, 92626
        • Forest Investigative Site 062
      • Fresno, California, United States, 93720
        • Forest Investigative Site 050
      • San Francisco, California, United States, 94118
        • Forest Investigative Site 024
      • Santa Ana, California, United States, 92705
        • Forest Investigative Site 071
    • Colorado
      • Denver, Colorado, United States, 80262
        • Forest Investigative Site 002
    • Florida
      • Boca Raton, Florida, United States, 33486
        • Forest Investigative Site 021
      • Boynton Beach, Florida, United States, 33426
        • Forest Investigative Site 052
      • Delray Beach, Florida, United States, 33445
        • Forest Investigative Site 070
      • Fort Myers, Florida, United States, 33912
        • Forest Investigative Site 065
      • Hallandale Beach, Florida, United States, 33009
        • Forest Investigative Site 043
      • Hallandale Beach, Florida, United States, 33009
        • Forest Investigative Site 044
      • Miami, Florida, United States, 33137
        • Forest Investigative Site 001
      • North Miami, Florida, United States, 33161
        • Forest Investigative Site 034
      • Orlando, Florida, United States, 32806
        • Forest Investigative Site 068
      • Palm Beach Gardens, Florida, United States, 33410
        • Forest Investigative Site 038
      • Saint Petersburg, Florida, United States, 33709
        • Forest Investigative Site 008
      • Tampa, Florida, United States, 33617
        • Forest Investigative Site 028
    • Georgia
      • Snellville, Georgia, United States, 30078
        • Forest Investigative Site 009
    • Illinois
      • Joliet, Illinois, United States, 60435
        • Forest Investigative Site 069
    • Michigan
      • Kalamazoo, Michigan, United States, 49048
        • Forest Investigative Site 045
    • Missouri
      • Saint Loius, Missouri, United States, 63104
        • Forest Investigative Site 014
    • New Jersey
      • Long Branch, New Jersey, United States, 07742
        • Forest Investigative Site 064
      • Morristown, New Jersey, United States, 07960
        • Forest Investigative Site 011
      • New Brunswick, New Jersey, United States, 08903
        • Forest Investigative Site 003
    • New York
      • Albany, New York, United States, 12205
        • Forest Investigative Site 048
      • Buffalo, New York, United States, 14215
        • Forest Investigative Site 006
      • White Plains, New York, United States, 10605
        • Forest Investigative Site 004
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Forest Investigative Site 027
      • Toledo, Ohio, United States, 43623
        • Forest Investigative Site 012
    • Oregon
      • Portland, Oregon, United States, 97210
        • Forest Investigative Site 020
    • Pennsylvania
      • Greensburg, Pennsylvania, United States, 15601
        • Forest Investigative Site 032
      • Jenkintown, Pennsylvania, United States, 19046
        • Forest Investigative Site 018
    • Rhode Island
      • East Providence, Rhode Island, United States, 02914
        • Forest Investigative Site 067
    • Texas
      • Austin, Texas, United States, 78757
        • Forest Investigative Site 041
      • San Antonio, Texas, United States, 78229
        • Forest Investigative Site 017
    • Virginia
      • Richmond, Virginia, United States, 23229
        • Forest Investigative Site 013
    • Washington
      • Tacoma, Washington, United States, 98405
        • Forest Investigative Site 026

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ambulatory patients aged >/= 50 years
  • Diagnostic evidence of probable Alzheimer's disease consistent with criteria from the National Institute of Neurological and Communicative Disorders and Stroke-Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) and the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, Text Revision (DSM-IV-TR)
  • Confirmatory magnetic resonance imaging (MRI) or computed tomographic (CT) scan within the prior 12 months.
  • Mini-Mental State Examination (MMSE) scores >/= 3 and </= 14 at Screening (Visit 1) and Baseline (Visit 2)
  • Ongoing daily acetylcholinesterase inhibitor (AChEI) therapy at a stable dose for at least 3 months prior to Screening (Visit 1). It is preferred that patients continue to receive the same AChEI therapy for the duration of the study.

Exclusion Criteria:

  • Patients with a modified Hachinski Ischemia Score greater than 4 at Screening.
  • Patients who have taken memantine within one month of Screening (Visit 1)
  • Patients who have a known hypersensitivity to memantine, neramexane, rimantadine, or amantadine.
  • Patients whose AChEI therapy is likely to be interrupted or discontinued during the course of the study.
  • Patients who are receiving therapy with more than one AChEI.
  • Patients with computed tomography (CT) or magnetic resonance imaging (MRI) evidence of hydrocephalus, stroke, a space-occupying lesion, cerebral infection, or any clinically significant central nervous system disease other than Alzheimer's disease.
  • Patients with a DSM-IV Axis I disorder other than Alzheimer's disease, including amnestic disorders, schizophrenia or schizoaffective disorder, bipolar disorder, current major depressive episode, psychosis, panic, or post-traumatic stress disorder.
  • Patients who, in the clinician's judgement, are likely to be placed in a nursing home within the next 6 months.
  • Patients who had evidence of other neurological disorders that included, but were not limited to, stroke, Parkinson's disease, seizure disorder, or head injury with loss of consciousness within the prior 5 years
  • Patients who had dementia that was complicated by other organic disease
  • Patients who had dementia complicated by the presence of predominant delusions

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 Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Oral administration, once daily.
Drug: Placebo
Matching placebo oral administration once daily.
Active Comparator: Memantine ER
28mg, once daily. Oral administration for 24 weeks.
Drug: memantine ER
28mg(7mg capsules) once daily and oral administration for 24 weeks.
Other Names:
  • Namenda XR

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Severe Impairment Battery (SIB) at Week 24 (LOCF)
Time Frame: Baseline to week 24
The SIB was developed for the evaluation of cognitive function in patients with more advanced dementia, and evaluates the areas of memory, language, praxis, orientation, and attention. The SIB test items consist of simple, one-step commands presented with gestural cues that are repeated if necessary. The test contains 51 items, and the range of possible scores is 0 to 100 (with 0 being the worst result). The SIB has been shown to be a valid and reliable instrument sensitive to longitudinal change.
Baseline to week 24
Clinician's Interview-Based Impression of Change With Caregiver Input (CIBIC-plus) at Week 24 (LOCF)
Time Frame: Week 24
The CIBIC-Plus is a measure of an overall clinical effect and is based on a comprehensive evaluation at Baseline and later visits of four domains: general (overall clinical status), functional (including activities of daily living), cognitive, and behavioral. A skilled clinician interviews the patient, and includes information supplied by a knowledgeable caregiver. The CIBIC-Plus is a rating of the patient's global status relative to Baseline, ranging from a score of 1, indicating "marked improvement" to a score of 4, indicating "no change" to a score of 7, indicating "marked worsening."
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in the 19-Item Alzheimer's Disease Cooperative Study-Activities of Daily Living (ADCS-ADL19) Scale at Week 24 (LOCF)
Time Frame: Baseline to week 24
The ADCS-ADL19 modified inventory consists of 19 items used to measure the functional capabilities of patients with moderate to severe dementia. Each activity-of-daily-living (ADL) item comprises a series of hierarchical subquestions ranging from the highest level of independent performance to complete loss of ability to perform the ADL Inventory. The inventory is performed by interviewing a person in close contact with the patient and covers the most usual and consistent performance of the patient over the preceding 4 weeks. Response range is 0 (total disability) to 54 (total independence).
Baseline to week 24

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Forest Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Stephen M Graham, PhD, Forest Laboratories

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2005

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2007

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2006

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 4, 2006

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 5, 2006

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 16, 2010

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 25, 2010

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEM-MD-50

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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