Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease
This study has been completed.
Sponsor:
Forest Laboratories
Information provided by:
Forest Laboratories
ClinicalTrials.gov Identifier:
NCT00469456
First received: May 2, 2007
Last updated: December 21, 2009
Last verified: December 2009
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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:
Genetics Home Reference related topics:
Alzheimer disease
MedlinePlus related topics:
Alzheimer's Disease
U.S. FDA Resources
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
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 Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Memantine Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on June 18, 2013