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.
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- (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.
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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
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- (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
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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
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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. |
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Recruiting |
20 |
December 2008 |
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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
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Both |
50 Years and older |
No |
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United States |
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NCT00120874 |
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New York University School of Medicine |
- Forest Laboratories
- Fisher Center for Alzheimer's Research Foundation
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Principal Investigator: |
Barry Reisberg, M.D. |
New York University School of Medicine |
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Study Director: |
Sunnie Kenowsky, D.V.M. |
New York University School of Medicine |
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New York University School of Medicine |
July 2007 |