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

This study is ongoing, but not recruiting participants.
Sponsor:
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: February 18, 2014
Last verified: February 2014
  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: June 2014
Primary Completion Date: December 2012 (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:
  • Namenda
  • Activity therapy
  • Cognitive stimulation therapy
  • Exercise
  • Caregiver support
  • Alzheimer's
  • Alzheimer's Disease
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: February 18, 2014
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 July 24, 2014