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	Behavior: caregiver training, education, counseling and support	Phase IV

Further Study Details: 

Primary Outcomes: (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.
Secondary Outcomes: (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
Expected Total Enrollment:  20

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.

Ages Eligible for Study:  50 Years and above,  Genders Eligible for Study:  Both

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

Please refer to this study by ClinicalTrials.gov identifier  NCT00120874

Sunnie Kenowsky, D.V.M.      212-263-7164    sunnie.kenowsky@med.nyu.edu
Robyn Waters, B.A      212-263-8088    robyn.waters@med.nyu.edu

New York
      Fisher Alzheimer''''s Program, New York University School of Medicine, New York,  New York,  10016,  United States

Study chairs or principal investigators

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

Study ID Numbers:  H12444-01 A
Record last reviewed:  July 2005
Last Updated:  July 25, 2005
Record first received:  July 18, 2005
ClinicalTrials.gov Identifier:  NCT00120874
Health Authority: United States: Institutional Review Board
ClinicalTrials.gov processed this record on 2005-07-26