Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training
This study is ongoing, but not recruiting participants.
Sponsor:
New York University School of Medicine
Collaborators:
Forest Laboratories
Fisher Center for Alzheimer's Research Foundation
Information provided by (Responsible Party):
New York University School of Medicine
ClinicalTrials.gov Identifier:
NCT00120874
First received: July 12, 2005
Last updated: June 18, 2012
Last verified: June 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Alzheimer's Disease |
Behavioral: Individualized management of AD including caregiver training Drug: Memantine |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) |
| Official Title: | Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by New York University School of Medicine:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Severe Impairment Battery [ Time Frame: Baseline, 4, 12, 28, 52 weeks ] [ Designated as safety issue: No ]
- Mini-Mental State Examination [ Time Frame: Baseline, 4, 12, 28, 52 weeks ] [ Designated as safety issue: No ]
- Functional Assessment Staging [ Time Frame: Baseline, 4, 12, 28, 52 weeks ] [ Designated as safety issue: No ]
- Global Deterioration Scale [ Time Frame: Baseline, 4, 12, 28, 52 weeks ] [ Designated as safety issue: No ]
- Behavioral Pathology in Alzheimer's Disease-Frequency Weighted [ Time Frame: Baseline, 4, 12, 28, 52 weeks ] [ Designated as safety issue: No ]
- Memory and Behavior Problems Checklist [ Time Frame: Baseline, 4, 12, 28, 52 weeks ] [ Designated as safety issue: No ]
- All secondary outcomes scored at baseline, 4, 12, and 28 weeks [ Time Frame: Baseline, 4, 12, 28, 52 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 20 |
| Study Start Date: | August 2006 |
| Estimated Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Individualized Management and Memantine
|
Behavioral: Individualized management of AD including caregiver training
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.
Other Names:
Drug: Memantine
Patients receive 10 milligrams of memantine twice daily.
Other Name: Namenda
|
|
Active Comparator: Group 2
Only Memantine
|
Drug: Memantine
Patients receive 10 milligrams of memantine twice daily.
Other Name: Namenda
|
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 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.
Eligibility| Ages Eligible for Study: | 50 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00120874
Locations
| United States, New York | |
| Fisher Alzheimer's Program, New York University School of Medicine | |
| New York, New York, United States, 10016 | |
Sponsors and Collaborators
New York University School of Medicine
Forest Laboratories
Fisher Center for Alzheimer's Research Foundation
Investigators
| Principal Investigator: | Barry Reisberg, M.D. | New York University School of Medicine |
| Study Director: | Sunnie Kenowsky, D.V.M. | New York University School of Medicine |
More Information
Publications:
| Responsible Party: | New York University School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00120874 History of Changes |
| Other Study ID Numbers: | H12444-01 A, NAM MD 18 |
| Study First Received: | July 12, 2005 |
| Last Updated: | June 18, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by New York University School of Medicine:
|
Alzheimer's disease caregiver training caregiver counseling |
individualized management memantine dementia |
Additional relevant MeSH terms:
|
Alzheimer Disease Dementia Brain Diseases Central Nervous System Diseases Nervous System Diseases Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders Memantine Dopamine Agents |
Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Physiological Effects of Drugs Excitatory Amino Acid Antagonists Excitatory Amino Acid Agents Antiparkinson Agents Anti-Dyskinesia Agents Central Nervous System Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on October 16, 2012
