Alzheimer's Disease Clinical Trial
Official title:
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.
Patients are randomly placed into one of two groups. Both groups receive memantine and
comprehensive evaluations at baseline, 4, 12,28 and 52 weeks. Additionally, group 1 receives
an individualized management program, which consists of home visits to get the patient
exercising, doing enjoyable activities and cognitive stimulation, educational sessions for
caregivers on coping with difficult situations and a caregiver support group to help with
questions and emotional concerns.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)
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