Status:
COMPLETED
Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training
Lead Sponsor:
NYU Langone Health
Collaborating Sponsors:
Forest Laboratories
Fisher Center for Alzheimer's Research Foundation
Conditions:
Alzheimer's Disease
Eligibility:
All Genders
50+ years
Phase:
PHASE4
Brief Summary
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 dwellin...
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00120874
Start Date
August 1 2006
End Date
November 1 2011
Last Update
October 25 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Fisher Alzheimer's Program, New York University School of Medicine
New York, New York, United States, 10016