Overview

This trial is active, not recruiting.

Condition alzheimer's disease
Treatments individualized management of ad including caregiver training, memantine
Phase phase 4
Sponsor New York University School of Medicine
Collaborator Forest Laboratories
Start date August 2006
End date December 2012
Trial size 20 participants
Trial identifier NCT00120874, H12444-01 A, NAM MD 18

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Experimental)
Individualized Management including caregiver training and Memantine
individualized management of ad including caregiver training Namenda
Individualized management program: 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.
memantine Namenda
Patients receive 10 milligrams of memantine twice daily.
(Active Comparator)
Only Memantine
memantine Namenda
Patients receive 10 milligrams of memantine twice daily.

Primary Outcomes

Measure
Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) global score at baseline, 4, 12,28 and 52 weeks
time frame: Baseline, 4, 12, 28, 52 weeks
the changes from baseline to weeks 28 & 52 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.
time frame: Baseline, 4, 12, 28, 52 weeks

Secondary Outcomes

Measure
Severe Impairment Battery
time frame: Baseline, 4, 12, 28, 52 weeks
Mini-Mental State Examination
time frame: Baseline, 4, 12, 28, 52 weeks
Functional Assessment Staging
time frame: Baseline, 4, 12, 28, 52 weeks
Global Deterioration Scale
time frame: Baseline, 4, 12, 28, 52 weeks
Behavioral Pathology in Alzheimer's Disease-Frequency Weighted
time frame: Baseline, 4, 12, 28, 52 weeks
Memory and Behavior Problems Checklist
time frame: Baseline, 4, 12, 28, 52 weeks
All secondary outcomes scored at baseline, 4, 12, and 28 weeks
time frame: Baseline, 4, 12, 28, 52 weeks

Eligibility Criteria

Male or female participants at least 50 years old.

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

Additional Information

Official title Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial
Principal investigator Barry Reisberg, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by New York University School of Medicine.