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Memantine and Comprehensive,Individualized Management of Alzheimer's Patients and Caregiver Training
This study is currently recruiting participants.
Study NCT00120874   Information provided by New York University School of Medicine
First Received: July 12, 2005   Last Updated: July 17, 2007   History of Changes
This Tabular View shows the required WHO registration data elements as marked by

July 12, 2005
July 17, 2007
August 2006
  • 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.
  • (1)Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) global score at baseline, 4, 12, and 28 weeks
  • (2)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.
Complete list of historical versions of study NCT00120874 on ClinicalTrials.gov Archive Site
  • 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
  • (1)Severe Impairment Battery
  • (2)Mini-Mental State Examination
  • (3)Functional Assessment Staging
  • (4)Global Deterioration Scale
  • (5)Behavioral Pathology in Alzheimer's Disease-Frequency Weighted
  • (6)Memory and Behavior Problems Checklist
  • All secondary outcomes scored at baseline, 4, 12, and 28 weeks
 
Memantine and Comprehensive,Individualized Management of Alzheimer's Patients and Caregiver Training
Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial

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.

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.

Phase IV
Interventional
Other, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Alzheimer's Disease
  • Behavioral: Caregiver Training Home visits: exercising, doing activities
  • Drug: memantine
 
Reisberg B, Kenowsky S, Franssen EH, Auer SR, Souren LE. Towards a science of Alzheimer's disease management: a model based upon current knowledge of retrogenesis. Int Psychogeriatr. 1999 Mar;11(1):7-23.

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
20
December 2008
 

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
Both
50 Years and older
No
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
United States
 
 
NCT00120874
 
 
New York University School of Medicine
  • Forest Laboratories
  • Fisher Center for Alzheimer's Research Foundation
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
New York University School of Medicine
July 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.