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Memantine and Comprehensive,Individualized Management of Alzheimer's Patients and Caregiver Training

This study is currently recruiting participants.
Verified by New York University School of Medicine, July 2007

Sponsors and Collaborators: New York University School of Medicine
Forest Laboratories
Fisher Center for Alzheimer's Research Foundation
Information provided by: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT00120874
  Purpose

The purpose of this study is to determine whether a comprehensive, individualized management approach with caregiver training and medication with memantine will alleviate symptoms in community dwelling patients with moderate to severe Alzheimer's disease.


Condition Intervention Phase
Alzheimer's Disease
Behavioral: Caregiver Training Home visits: exercising, doing activities
Drug: memantine
Phase IV

Genetics Home Reference related topics:   Alzheimer disease   

MedlinePlus related topics:   Alzheimer's Caregivers    Alzheimer's Disease    Caregivers    Dementia   

Drug Information available for:   Memantine    Memantine hydrochloride   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Other, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:   Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial

Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) global score at baseline, 4, 12, and 28 weeks
  • the changes from baseline to week 28 in the Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory modified for severe dementia (ADCS-ADLsev) assessed at 0, 4, 12, 28 weeks.

Secondary Outcome Measures:
  • Severe Impairment Battery
  • Mini-Mental State Examination
  • Functional Assessment Staging
  • Global Deterioration Scale
  • Behavioral Pathology in Alzheimer's Disease-Frequency Weighted
  • Memory and Behavior Problems Checklist
  • All secondary outcomes scored at baseline, 4, 12, and 28 weeks

Estimated Enrollment:   20
Study Start Date:   August 2006
Estimated Study Completion Date:   December 2008

Detailed Description:

Presently some 4.5 million people are afflicted with Alzheimer's disease in the United States. At present pharmacologic treatment, although beneficial, is not curative. Certain nonpharmacologic treatments have assisted caregivers of AD patients by reducing their stress and burden, and others have aided patients, by improving their mood and physical functioning. Comprehensive, individualized approaches to improving Alzheimer's patients' symptomatology and caregiver stress and burden have not been systematically investigated in Alzheimer's patient care. This study seeks to train and counsel caregivers as well as develop an individualized, comprehensive management program that will seek to enhance the functioning of each patient participant.

  Eligibility
Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

  • Patients, 50 years of age or greater, residing in the community
  • Presence of a family and/or professional caregiver willing and able to participate in all aspects of this study
  • A diagnosis of probable Alzheimer's disease by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV) and NINCDS-ADRDA (McKhann,et al., Neurology,1984;34: 939-944) criteria
  • A CT or MRI brain scan and medical work up compatible with the DSM-IV and NINCDS-ADRDA diagnostic criteria for Alzheimer's disease
  • Mini-Mental State Examination scores of 3-14
  • Global Deterioration Scale stages of 5 or 6
  • A stage of 6a or greater on the Functional Assessment Staging instrument signifying the presence of dementia deficits in the ability to perform one or more basic activities of daily living

Exclusion Criteria:

  • Non-English speaking patients and/or caregivers
  • Subjects with a diagnosis of dementia due to conditions other than Alzheimer's disease.
  • Subjects with a diagnosis of vascular dementia or a score greater than 4 on the modified Hachinski Ischemic Rating scale
  • Patients with a major depressive disorder
  • Patients with clinically significant laboratory abnormalities
  • Patients receiving investigational pharmacologic agents
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00120874

Contacts
Contact: Sunnie Kenowsky, D.V.M.     212-263-7164     sunnie.kenowsky@med.nyu.edu    
Contact: Thet Oo, M.D.     212-263-8088     thet.oo@med.nyu.edu    

Locations
United States, New York
Fisher Alzheimer's Program, New York University School of Medicine     Recruiting
      New York, New York, United States, 10016
      Contact: Sunnie Kenowsky, D.V.M.     212-263-7164     sunnie.kenowsky@med.nyu.edu    
      Contact: Thet Oo, M.D.     212-263-8088     thet.oo@med.nyu.edu    

Sponsors and Collaborators
New York University School of Medicine
Forest Laboratories
Fisher Center for Alzheimer's Research Foundation

Investigators
Principal Investigator:     Barry Reisberg, M.D.     New York University School of Medicine    
Study Director:     Sunnie Kenowsky, D.V.M.     New York University School of Medicine    
  More Information


Publications:

Study ID Numbers:   H12444-01 A
First Received:   July 12, 2005
Last Updated:   July 17, 2007
ClinicalTrials.gov Identifier:   NCT00120874
Health Authority:   United States: Institutional Review Board

Keywords provided by New York University School of Medicine:
Alzheimer's disease  
caregiver training  
caregiver counseling  
individualized management
memantine
dementia

Study placed in the following topic categories:
Excitatory Amino Acids
Dopamine
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Alzheimer Disease
Memantine
Central Nervous System Diseases
Neurodegenerative Diseases
Brain Diseases
Dementia
Cognition Disorders
Delirium

Additional relevant MeSH terms:
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Dyskinesia Agents
Nervous System Diseases
Physiological Effects of Drugs
Antiparkinson Agents
Excitatory Amino Acid Agents
Pharmacologic Actions
Therapeutic Uses
Dopamine Agents
Tauopathies
Central Nervous System Agents
Excitatory Amino Acid Antagonists

ClinicalTrials.gov processed this record on October 28, 2008




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