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

• Status: Completed
• Trial end date: 2011-11-01
• Target enrollment: 0
• Participant gender: All

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 dwelling patients with moderate to severe Alzheimer's disease.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Collaborators: Fisher Center for Alzheimer's Research Foundation; Forest Laboratories
• Treatments: Memantine

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