Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease

December 21, 2009 updated by: Forest Laboratories

A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)

The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

265

Phase

  • Phase 4

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

  • Australia
    • New South Wales
      • East Gosford, New South Wales, Australia, 2250
        • Forest Investigative Site
      • Hornsby, New South Wales, Australia, 2077
        • Forest Investigative Site
      • Kogarah, New South Wales, Australia, 2217
        • Forest Investigative Site
      • Newcastle, New South Wales, Australia, 2300
        • Forest Investigative Site
      • Randwick, New South Wales, Australia, 2031
        • Forest Investigative Site
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Forest Investigative Site
      • Toowoomba, Queensland, Australia, 4350
        • Forest Investigative Site
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Forest Investigative Site
      • Woodville, South Australia, Australia, 5011
        • Forest Investigative Site
    • Victoria
      • Box Hill, Victoria, Australia, 3182
        • Forest Investigative Site
      • Frankston, Victoria, Australia, 3199
        • Forest Investigative Site
      • Heidelberg West, Victoria, Australia, 3081
        • Forest Investigative Site
      • Kew, Victoria, Australia, 3101
        • Forest Investigative Site
    • Western Australia
      • Perth, Western Australia, Australia, 6001
        • Forest Investigative Site
  • New Zealand
      • Christchurch, New Zealand, 8022
        • Forest Investigative Site
      • North Shore, New Zealand, 0622
        • Forest Investigative Site
      • Timaru, New Zealand, 8022
        • Forest Investigative Site
  • South Africa
    • E. Cape
      • George, E. Cape, South Africa, 6529
        • Forest Investigative Site
      • Port Elizabeth, E. Cape, South Africa, 6014
        • Forest Investigative Site
    • Gauteng
      • Johannesburg, Gauteng, South Africa, 2052
        • Forest Investigative Site
      • Johannesburg, Gauteng, South Africa, 4001
        • Forest Investigative Site
      • Pretoria, Gauteng, South Africa, 0182
        • Forest Investigative Site
    • KZ-Natal
      • Durban, KZ-Natal, South Africa, 4001
        • Forest Investigative Site
    • W. Cape
      • Cape Town, W. Cape, South Africa, 7500
        • Forest Investigative Site
      • Cape Town, W. Cape, South Africa, 7530
        • Forest Investigative Site

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Male and female outpatients, 50 years or older, native English speakers, meeting National Institute of Neurological and Communicative Disorders and Stroke--Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA) criteria for probable AD with a Mini Mental State Examination (MMSE) score of 10 to 19 at Screening and Baseline

Exclusion Criteria:

  • Current Diagnostic and Statistical Manual of Mental Disorders--Fourth Edition (DSM-IV) Axis I disorder other than AD
  • Previous imaging results not consistent with the diagnosis of AD
  • Modified Hachinski Ischemia Score greater than 4
  • Evidence of other neurologic disorders
  • Clinically significant systemic disease
  • A known or suspected history of alcohol or drug abuse in the past 5 years
  • Taking excluded medication
  • Previous treatment with commercial memantine

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: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1
Memantine 20mg (10mg twice daily) oral administration for 12 weeks
Drug: Memantine
Memantine 20mg (10mg twice daily) oral administration for 12 weeks
Other Names:
  • Namenda®
Placebo Comparator: 2
Placebo oral administration twice daily for 12 weeks
Drug: placebo
Placebo oral administration twice daily for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12
Time Frame: Baseline to Week 12
FLCI is a standardized & validated instrument for evaluating functional communication in pts with moderate-to-severe Alzheimer's that can be used to obtain Baseline information & to track patients' capabilities thereafter. The FLCI evaluates 10 areas: greeting and naming, answering questions, writing, sign comprehension, object-to-picture matching, word reading and comprehension, following commands, pantomime, gesture, and conversation. The FLCI total score ranges from 0 to 87, a higher score denotes better functional communication, and takes approximately 30 minutes to complete.
Baseline to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) [Total Score of Social Communication and Communication of Basic Needs Subscores] at Week 12
Time Frame: Baseline to Week 12
The ASHA FACS assesses & measures functional communication skills of adults with speech, language, & cognitive communication disorders. The measure, which comprises 43 items and takes approximately 20 minutes to complete, assesses functional communication in four areas: social communication; communication of basic needs; reading, writing, and number concepts; and daily planning. Total score of subdomains [Social Communication and Communication of Basic Needs] ranges from 0-196. A higher score denotes better communication.
Baseline to Week 12

Collaborators and Investigators

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

Sponsor

Forest Laboratories

Investigators

  • Principal Investigator: F C Potocnik

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

April 1, 2007

Primary Completion (Actual)

November 1, 2008

Study Completion (Actual)

November 1, 2008

Study Registration Dates

First Submitted

May 2, 2007

First Submitted That Met QC Criteria

May 3, 2007

First Posted (Estimate)

May 4, 2007

Study Record Updates

Last Update Posted (Estimate)

December 24, 2009

Last Update Submitted That Met QC Criteria

December 21, 2009

Last Verified

December 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MEM-MD-71

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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