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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: September 4, 2014
Last verified: September 2014

July 12, 2005
September 4, 2014
August 2006
December 2012   (final data collection date for primary outcome 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 ] [ 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 ]
  • (1)Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) global score at baseline, 4, 12, and 28 weeks
  • (2)the changes from baseline to week 28 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.
Complete list of historical versions of study NCT00120874 on ClinicalTrials.gov Archive Site
  • 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 ]
  • (1)Severe Impairment Battery
  • (2)Mini-Mental State Examination
  • (3)Functional Assessment Staging
  • (4)Global Deterioration Scale
  • (5)Behavioral Pathology in Alzheimer's Disease-Frequency Weighted
  • (6)Memory and Behavior Problems Checklist
  • All secondary outcomes scored at baseline, 4, 12, and 28 weeks
Not Provided
Not Provided
 
Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training
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.

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Alzheimer's Disease
  • 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
  • Experimental: Group 1
    Individualized Management including caregiver training and Memantine
    Interventions:
    • Behavioral: Individualized management of AD including caregiver training
    • Drug: Memantine
  • Active Comparator: Group 2
    Only Memantine
    Intervention: Drug: Memantine

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
20
February 2015
December 2012   (final data collection date for primary outcome measure)

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
Both
50 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00120874
H12444-01 A, NAM MD 18
Yes
New York University School of Medicine
New York University School of Medicine
  • Forest Laboratories
  • Fisher Center for Alzheimer's Research Foundation
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
New York University School of Medicine
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP