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

This study has been completed.
Sponsor:
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00469456
First received: May 2, 2007
Last updated: December 21, 2009
Last verified: December 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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, 4001
Forest Investigative Site
Johannesburg, Gauteng, South Africa, 2052
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, 7530
Forest Investigative Site
Cape Town, W. Cape, South Africa, 7500
Sponsors and Collaborators
Forest Laboratories
Investigators
Principal Investigator: F C Potocnik
  More Information

No publications provided

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
Study First Received: May 2, 2007
Results First Received: November 3, 2009
Last Updated: December 21, 2009
Health Authority: Australia: Human Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
South Africa: National Health Research Ethics Council
South Africa: Medicines Control Council
New Zealand: Health Research Council
New Zealand: Medsafe

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

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

ClinicalTrials.gov processed this record on October 23, 2014