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

NYU Langone Health

Status and phase

Completed

Phase 4

Conditions

Alzheimer's Disease

Treatments

Behavioral: Individualized management of AD including caregiver training

Drug: Memantine

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00120874

NAM MD 18 (Other Grant/Funding Number)

H12444-01 A

Details and patient eligibility

About

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.

Full 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 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.

Enrollment

20 patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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