Effect of Memantine on Functional Communication in Patients With Alzheimer's Disease - Full Text View

Sponsored by:	Forest Laboratories
Information provided by:	Forest Laboratories
ClinicalTrials.gov Identifier:	NCT00469456

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 IV

Genetics Home Reference related topics: Alzheimer disease

MedlinePlus related topics: Alzheimer's Disease

Drug Information available for: Memantine Memantine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized, Double-Blind, Placebo-Controlled Evaluation of the Efficacy of Memantine on Functional Communication in Patients With Alzheimer's Disease

Further study details as provided by Forest Laboratories:

Primary Outcome Measures:

Functional Linguistic Communication Inventory (FLCI) at Week 12 [ Time Frame: Week 12 ]

Secondary Outcome Measures:

American Speech-Language-Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS) at Week 12 [ Time Frame: Week 12 ]

Estimated Enrollment:	250
Study Start Date:	April 2007
Estimated Study Completion Date:	November 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Memantine oral administration twice daily for 12 weeks	Drug: Memantine Memantine oral administration twice daily for 12 weeks
2: Placebo Comparator 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
No 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
Newcastle, New South Wales, Australia, 2300
Forest Investigative Site
Hornsby, New South Wales, Australia, 2077
Forest Investigative Site
Randwick, New South Wales, Australia, 2031
Forest Investigative Site
Kogarah, New South Wales, Australia, 2217
Forest Investigative Site
East Gosford, New South Wales, Australia, 2250
Australia, Queensland
Forest Investigative Site
Chermside, Queensland, Australia, 4032
Forest Investigative Site
Toowoomba, Queensland, Australia, 4350
Australia, South Australia
Forest Investigative Site
Woodville, South Australia, Australia, 5011
Forest Investigative Site
Adelaide, South Australia, Australia, 5000
Australia, Victoria
Forest Investigative Site
Heidelberg West, Victoria, Australia, 3081
Forest Investigative Site
Box Hill, Victoria, Australia, 3182
Forest Investigative Site
Kew, Victoria, Australia, 3101
Forest Investigative Site
Frankston, Victoria, Australia, 3199
Australia, Western Australia
Forest Investigative Site
Perth, Western Australia, Australia, 6001
New Zealand
Forest Investigative Site
North Shore, New Zealand, 0622
Forest Investigative Site
Christchurch, New Zealand, 8022
Forest Investigative Site
Timaru, New Zealand, 8022
South Africa, E. Cape
Forest Investigative Site
George, E. Cape, South Africa, 6529
Forest Investigative Site
Port Elizabeth, E. Cape, South Africa, 6014
South Africa, Gauteng
Forest Investigative Site
Johannesburg, Gauteng, South Africa, 4001
Forest Investigative Site
Johannesburg, Gauteng, South Africa, 2052
Forest Investigative Site
Pretoria, Gauteng, South Africa, 0182
South Africa, KZ-Natal
Forest Investigative Site
Durban, KZ-Natal, South Africa, 4001
South Africa, W. Cape
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

Unaffiliated

More Information

No publications provided

Responsible Party:	Forest Research Institute, a division of Forest Laboratories, Inc. ( Stephen Graham, PhD, Sr. Director )
Study ID Numbers:	MEM-MD-71
Study First Received:	May 2, 2007
Last Updated:	September 17, 2008
ClinicalTrials.gov Identifier:	NCT00469456 History of Changes
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

Study placed in the following topic categories:

Excitatory Amino Acids
Neurotransmitter Agents
Alzheimer Disease
Central Nervous System Diseases
Brain Diseases
Neurodegenerative Diseases
Cognition Disorders

Delirium, Dementia, Amnestic, Cognitive Disorders
Dopamine
Mental Disorders
Memantine
Dopamine Agents
Dementia
Delirium

Additional relevant MeSH terms:

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Alzheimer Disease
Nervous System Diseases
Antiparkinson Agents
Central Nervous System Diseases
Excitatory Amino Acid Agents
Brain Diseases
Neurodegenerative Diseases

Pharmacologic Actions
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Therapeutic Uses
Memantine
Dopamine Agents
Dementia
Tauopathies
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on May 06, 2009