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

Alzheimer's Disease Clinical Trial

Official title:

Memantine and Comprehensive, Individualized, Patient Centered Management of Alzheimer's Disease: A Randomized Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00120874
• Other study ID #: H12444-01 A
• Secondary ID: NAM MD 18
• Status: Active, not recruiting
• Phase: Phase 4
• First received: July 12, 2005
• Last updated: September 4, 2014
• Start date: August 2006
• Est. completion date: February 2015

Study information

• Verified date: September 2014
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: February 2015
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease

Intervention

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.

Drug:
• Memantine
Patients receive 10 milligrams of memantine twice daily.

Locations

Country	Name	City	State
United States	Fisher Alzheimer's Program, New York University School of Medicine	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York University School of Medicine	Fisher Center for Alzheimer's Research Foundation, Forest Laboratories

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinician Interview-Based Assessment of Change Plus Caregiver Input (CIBIC-Plus) global score at baseline, 4, 12,28 and 52 weeks		Baseline, 4, 12, 28, 52 weeks	No
Primary	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.		Baseline, 4, 12, 28, 52 weeks	No
Secondary	Severe Impairment Battery		Baseline, 4, 12, 28, 52 weeks	No
Secondary	Mini-Mental State Examination		Baseline, 4, 12, 28, 52 weeks	No
Secondary	Functional Assessment Staging		Baseline, 4, 12, 28, 52 weeks	No
Secondary	Global Deterioration Scale		Baseline, 4, 12, 28, 52 weeks	No
Secondary	Behavioral Pathology in Alzheimer's Disease-Frequency Weighted		Baseline, 4, 12, 28, 52 weeks	No
Secondary	Memory and Behavior Problems Checklist		Baseline, 4, 12, 28, 52 weeks	No
Secondary	All secondary outcomes scored at baseline, 4, 12, and 28 weeks		Baseline, 4, 12, 28, 52 weeks	No