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

Primary Purpose

Alzheimer's Disease

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
Memantine
placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alzheimer's Disease focused on measuring memantine, Alzheimer's Disease, communication

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Memantine 20mg (10mg twice daily) oral administration for 12 weeks

Placebo oral administration twice daily for 12 weeks

Outcomes

Primary Outcome Measures

Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at 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.

Secondary Outcome Measures

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
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.

Full Information

First Posted
May 2, 2007
Last Updated
December 21, 2009
Sponsor
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00469456
Brief Title
Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
Official Title
A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Forest Laboratories

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease
Keywords
memantine, Alzheimer's Disease, communication

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Memantine 20mg (10mg twice daily) oral administration for 12 weeks
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo oral administration twice daily for 12 weeks
Intervention Type
Drug
Intervention Name(s)
Memantine
Other Intervention Name(s)
Namenda®
Intervention Description
Memantine 20mg (10mg twice daily) oral administration for 12 weeks
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Placebo oral administration twice daily for 12 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12
Description
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.
Time Frame
Baseline to Week 12
Secondary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
F C Potocnik
Official's Role
Principal Investigator
Facility Information:
Facility Name
Forest Investigative Site
City
East Gosford
State/Province
New South Wales
ZIP/Postal Code
2250
Country
Australia
Facility Name
Forest Investigative Site
City
Hornsby
State/Province
New South Wales
ZIP/Postal Code
2077
Country
Australia
Facility Name
Forest Investigative Site
City
Kogarah
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Forest Investigative Site
City
Newcastle
State/Province
New South Wales
ZIP/Postal Code
2300
Country
Australia
Facility Name
Forest Investigative Site
City
Randwick
State/Province
New South Wales
ZIP/Postal Code
2031
Country
Australia
Facility Name
Forest Investigative Site
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Forest Investigative Site
City
Toowoomba
State/Province
Queensland
ZIP/Postal Code
4350
Country
Australia
Facility Name
Forest Investigative Site
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
Forest Investigative Site
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Forest Investigative Site
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3182
Country
Australia
Facility Name
Forest Investigative Site
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
Forest Investigative Site
City
Heidelberg West
State/Province
Victoria
ZIP/Postal Code
3081
Country
Australia
Facility Name
Forest Investigative Site
City
Kew
State/Province
Victoria
ZIP/Postal Code
3101
Country
Australia
Facility Name
Forest Investigative Site
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6001
Country
Australia
Facility Name
Forest Investigative Site
City
Christchurch
ZIP/Postal Code
8022
Country
New Zealand
Facility Name
Forest Investigative Site
City
North Shore
ZIP/Postal Code
0622
Country
New Zealand
Facility Name
Forest Investigative Site
City
Timaru
ZIP/Postal Code
8022
Country
New Zealand
Facility Name
Forest Investigative Site
City
George
State/Province
E. Cape
ZIP/Postal Code
6529
Country
South Africa
Facility Name
Forest Investigative Site
City
Port Elizabeth
State/Province
E. Cape
ZIP/Postal Code
6014
Country
South Africa
Facility Name
Forest Investigative Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
2052
Country
South Africa
Facility Name
Forest Investigative Site
City
Johannesburg
State/Province
Gauteng
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Forest Investigative Site
City
Pretoria
State/Province
Gauteng
ZIP/Postal Code
0182
Country
South Africa
Facility Name
Forest Investigative Site
City
Durban
State/Province
KZ-Natal
ZIP/Postal Code
4001
Country
South Africa
Facility Name
Forest Investigative Site
City
Cape Town
State/Province
W. Cape
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Forest Investigative Site
City
Cape Town
State/Province
W. Cape
ZIP/Postal Code
7530
Country
South Africa

12. IPD Sharing Statement

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

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