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

• 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.

• 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

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.

• 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 and Memantine
  Interventions:

  • Behavioral: Individualized management of AD including caregiver training
  • Drug: Memantine
• Active Comparator: Group 2
  Only Memantine
  Intervention: Drug: Memantine

• 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.
• 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.

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

• Forest Laboratories
• Fisher Center for Alzheimer's Research Foundation