Clinical trial NCT00120874: Memantine and Comprehensive, Individualized Management of Alzheimer's Disease and Caregiver Training
Official title: Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease
caregiver training
caregiver counseling
individualized management
memantine
dementia
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Forest Laboratories
name: Fisher Center for Alzheimer's Research Foundation
First posted: 2005-07-19
Enrollment: 20
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief 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.

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 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

Primary outcomes:
measure: Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
timeFrame: Baseline to 28 weeks
measure: Change From Baseline in Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) Global Score (New York Univeristy Version)
timeFrame: Baseline to 52 weeks
measure: Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
timeFrame: Baseline to 28 weeks
measure: Change From Baseline of The Alzheimer's Disease Cooperative Study Activities of Daily Living Inventory Modified for Severe Dementia Abbreviated Version (ADCS-ADLsev-abv)
timeFrame: Baseline to 52 weeks
Secondary outcomes:
measure: Change From Baseline of the Severe Impairment Battery (SIB)
timeFrame: Baseline to 28 weeks
measure: Change From Baseline of the Severe Impairment Battery (SIB)
timeFrame: Baseline to 52 weeks
measure: Change From Baseline of the Mini-Mental State Examination (MMSE)
timeFrame: Baseline to 28 weeks
measure: Change From Baseline of the Mini-Mental State Examination (MMSE)
timeFrame: Baseline to 52 weeks
measure: Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
timeFrame: Baseline to 28 weeks
measure: Change From Baseline of the Functional Assessment Staging Disability Score (FAST-DS)
timeFrame: Baseline to 52 weeks
measure: Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
timeFrame: Baseline to 28 weeks
measure: Change From Baseline of The Behavioral Pathology in Alzheimer's Disease Frequency Weighted Severity Scale (BEHAVE-AD-FW)
timeFrame: Baseline to 52 weeks
measure: Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
timeFrame: Baseline to 28 weeks
measure: Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
timeFrame: Baseline to 28 weeks
measure: Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Frequency
timeFrame: Baseline to 52 weeks
measure: Change From Baseline of the Revised Memory and Behavior Problems Checklist (RMBPC): Caregiver Reaction
timeFrame: Baseline to 52 weeks
Other outcomes:
Locations:
city: New York
country: United States
facility: Fisher Alzheimer's Program, New York University School of Medicine
state: New York
Study officials:
affiliation: NYU Langone Health
name: Barry Reisberg, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: NYU Langone Health
name: Sunnie Kenowsky, D.V.M.
role: STUDY_DIRECTOR
References:
citation: Reisberg B, Kenowsky S, Franssen EH, Auer SR, Souren LE. Towards a science of Alzheimer's disease management: a model based upon current knowledge of retrogenesis. Int Psychogeriatr. 1999 Mar;11(1):7-23. doi: 10.1017/s1041610299005554.
citation: Teri L, Gibbons LE, McCurry SM, Logsdon RG, Buchner DM, Barlow WE, Kukull WA, LaCroix AZ, McCormick W, Larson EB. Exercise plus behavioral management in patients with Alzheimer disease: a randomized controlled trial. JAMA. 2003 Oct 15;290(15):2015-22. doi: 10.1001/jama.290.15.2015.