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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00469456
First Posted: May 4, 2007
Last Update Posted: December 24, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Forest Laboratories
  Purpose
The objective of this study is to evaluate the effect of memantine versus placebo on functional communication in patients with Alzheimer's Disease

Condition Intervention Phase
Alzheimer's Disease Drug: Memantine Drug: placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease (AD)

Resource links provided by NLM:


Further study details as provided by Forest Laboratories:

Primary Outcome Measures:
  • Change From Baseline in Functional Linguistic Communication Inventory (FLCI) at Week 12 [ Time Frame: Baseline to Week 12 ]

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 [ Time Frame: Baseline to Week 12 ]

Enrollment: 265
Study Start Date: April 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Namenda®
Placebo Comparator: 2
Placebo oral administration twice daily for 12 weeks
Drug: placebo
Placebo oral administration twice daily for 12 weeks

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00469456


Locations
Australia, New South Wales
Forest Investigative Site
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
Australia, Queensland
Forest Investigative Site
Chermside, Queensland, Australia, 4032
Forest Investigative Site
Toowoomba, Queensland, Australia, 4350
Australia, South Australia
Forest Investigative Site
Adelaide, South Australia, Australia, 5000
Forest Investigative Site
Woodville, South Australia, Australia, 5011
Australia, Victoria
Forest Investigative Site
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
Australia, Western Australia
Forest Investigative Site
Perth, Western Australia, Australia, 6001
New Zealand
Forest Investigative Site
Christchurch, New Zealand, 8022
Forest Investigative Site
North Shore, New Zealand, 0622
Forest Investigative Site
Timaru, New Zealand, 8022
South Africa
Forest Investigative Site
George, E. Cape, South Africa, 6529
Forest Investigative Site
Port Elizabeth, E. Cape, South Africa, 6014
Forest Investigative Site
Johannesburg, Gauteng, South Africa, 2052
Forest Investigative Site
Johannesburg, Gauteng, South Africa, 4001
Forest Investigative Site
Pretoria, Gauteng, South Africa, 0182
Forest Investigative Site
Durban, KZ-Natal, South Africa, 4001
Forest Investigative Site
Cape Town, W. Cape, South Africa, 7500
Forest Investigative Site
Cape Town, W. Cape, South Africa, 7530
Sponsors and Collaborators
Forest Laboratories
Investigators
Principal Investigator: F C Potocnik
  More Information

Responsible Party: Stephen Graham, PhD, Sr. Director, Forest Research Institute, a division of Forest Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT00469456     History of Changes
Other Study ID Numbers: MEM-MD-71
First Submitted: May 2, 2007
First Posted: May 4, 2007
Results First Submitted: November 3, 2009
Results First Posted: December 7, 2009
Last Update Posted: December 24, 2009
Last Verified: December 2009

Keywords provided by Forest Laboratories:
memantine
Alzheimer's Disease
communication

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders
Memantine
Antiparkinson Agents
Anti-Dyskinesia Agents
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents